Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-11 @ 11:34 PM
Study NCT ID:
NCT02129205
Status:
TERMINATED
Last Update Posted:
2019-03-29
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711077', 'term': 'PF-06650808'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was prematurely terminated as a business decision prior to the start of the dose expansion stage.'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'PF-06650808 0.2 mg/kg', 'description': 'PF-06650808 0.2 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-06650808 0.4 mg/kg', 'description': 'PF-06650808 0.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-06650808 0.8 mg/kg', 'description': 'PF-06650808 0.8 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-06650808 1.6 mg/kg', 'description': 'PF-06650808 1.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'PF-06650808 2.0 mg/kg', 'description': 'PF-06650808 2.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'PF-06650808 2.4 mg/kg', 'description': 'PF-06650808 2.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'PF-06650808 3.0 mg/kg', 'description': 'PF-06650808 3.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'PF-06650808 3.6 mg/kg', 'description': 'PF-06650808 3.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.', 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7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 21', 'description': 'Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting \\>7 days; Febrile neutropenia; Grade\\>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia \\>=72 hours or platelets\\<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade\\>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Objective Response (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '97.5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '64.1'}, {'value': '14.3', 'groupId': 'OG005', 'lowerLimit': '0.4', 'upperLimit': '57.9'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '20.0', 'groupId': 'OG007', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years', 'description': 'Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \\>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who received at least 1 dose of study medication and had both baseline and at least 1 post-baseline tumor assessments. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'title': 'All causalities AE Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'All causalities AE Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'All causalities AE Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'All causalities AE Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'All causalities AE Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'All causalities SAE Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'All causalities SAE Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'All causalities SAE Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'All causalities SAE Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'All causalities SAE Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related AE Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related AE Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related AE Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related AE Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related AE Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related SAE Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related SAE Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related SAE Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related SAE Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Treatment related SAE Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Hemoglobin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Lymphocyte count increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}, {'title': 'Neutrophils count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Patelets count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'White blood cells decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. The participants who experienced laboratory test abnormalities were determined by investigators.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'title': 'Alanine aminotransferase (ALT) increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Alkaline phosphatase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Aspartate aminotransferase (AST) increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Bilirubin (Total) increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Creatinine increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypercalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hyperkalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypermagnesemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypernatremia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypoalbuminemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Hypocalcemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypokalemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypomagnesemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Hypophosphatemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus, bicarbonate or carbon dioxide, total protein and lactate dehydrogenase. The participants who experienced laboratory test abnormalities were determined by investigators.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Urinalysis included urine protein. Microscopic analyses were performed if dipstick was abnormal. The participants who experienced laboratory test abnormalities were determined by investigators.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'title': 'Sitting Systolic BP < 90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Sitting Diastolic BP < 50 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Sitting Pulse Rate < 40 BPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Sitting Pulse Rate > 120 BPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Supine Systolic BP < 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Supine Diastolic BP < 50 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Supine Pulse Rate < 40 BPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Supine Pulse Rate > 120 BPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Systolic BP < 90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Diastolic BP < 50 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Pulse Rate < 40 BPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Pulse Rate > 120 BPM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Increase: Sitting Systolic BP >= 30 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Increase: Sitting Diastolic BP >= 20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Increase: Systolic BP >= 30 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Increase: Diastolic BP >= 20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Decrease: Sitting Systolic BP >= 30 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Decrease: Sitting Diastolic BP >= 20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'Decrease: Systolic BP >= 30 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Decrease: Diastolic BP >= 20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (\\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\\<) 90 mm Hg; diastolic BP (DBP) \\>=20 mm Hg change from baseline, diastolic \\<50 mm Hg; 2), supine and standing pulse rate \\<40 or greater than (\\>) 120 beats per minute (bpm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'title': 'Serum PF-06650808 (ADC)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 6200 and 4290 ng/mL, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 11000 and 8030 ng/mL, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 18100 and 19400 ng/mL, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 34600 and 34900 ng/mL, respectively.', 'groupId': 'OG003'}, {'value': '59440', 'spread': '33', 'groupId': 'OG004'}, {'value': '54220', 'spread': '29', 'groupId': 'OG005'}, {'value': '76480', 'spread': '27', 'groupId': 'OG006'}, {'value': '71390', 'spread': '38', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 141000 and 92200 ng/mL, respectively', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06460005 (Total Antibody)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 5000 and 3690 ng/mL, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 8920 and 7860 ng/mL, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 21600 and 17700 ng/mL, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 30800 and 26800 ng/mL, respectively.', 'groupId': 'OG003'}, {'value': '48840', 'spread': '29', 'groupId': 'OG004'}, {'value': '54120', 'spread': '17', 'groupId': 'OG005'}, {'value': '93530', 'spread': '53', 'groupId': 'OG006'}, {'value': '65810', 'spread': '35', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 99600 and 62400 ng/mL, respectively.', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06380101 (Unconjugated Payload)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.735 and 0.627 ng/mL, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1.180 and 0.536 ng/mL, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.530 and 2.900 ng/mL, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.430 and 6.450 ng/mL, respectively.', 'groupId': 'OG003'}, {'value': '6.495', 'spread': '75', 'groupId': 'OG004'}, {'value': '5.916', 'spread': '81', 'groupId': 'OG005'}, {'value': '10.680', 'spread': '30', 'groupId': 'OG006'}, {'value': '9.060', 'spread': '82', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 26.100 and 14.400 ng/mL, respectively.', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06650808 (ADC)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 11400 ng/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 18200 ng/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 36700 and 38100 ng/mL, respectively.', 'groupId': 'OG003'}, {'value': '46240', 'spread': '12', 'groupId': 'OG004'}, {'value': '43910', 'spread': '17', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 36100 and 64900 ng/mL, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Serum PF-06460005 (Total Antibody)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 9920 ng/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 11900 ng/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 35100 and 51500 ng/mL, respectively.', 'groupId': 'OG003'}, {'value': '41610', 'spread': '34', 'groupId': 'OG004'}, {'value': '50640', 'spread': '23', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 62400 and 108000 ng/mL, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Serum PF-06380101 (Unconjugated Payload)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 1.200 ng/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 2.180 ng/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.220 and 4.730 ng/mL, respectively.', 'groupId': 'OG003'}, {'value': '4.518', 'spread': '78', 'groupId': 'OG004'}, {'value': '4.081', 'spread': '54', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.800 and 15.700 ng/mL, respectively.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4', 'description': 'Maximum observed serum concentration (Cmax) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data. PF-06650808 is comprised of an antibody (PF-06460005) and a cytotoxic agent (PF-06380101).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'title': 'Serum PF-06650808 (ADC)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.967', 'groupId': 'OG000', 'lowerLimit': '0.950', 'upperLimit': '0.983'}, {'value': '0.974', 'groupId': 'OG001', 'lowerLimit': '0.917', 'upperLimit': '1.03'}, {'value': '0.967', 'groupId': 'OG002', 'lowerLimit': '0.967', 'upperLimit': '0.967'}, {'value': '1.01', 'groupId': 'OG003', 'lowerLimit': '0.983', 'upperLimit': '1.03'}, {'value': '0.967', 'groupId': 'OG004', 'lowerLimit': '0.917', 'upperLimit': '1.08'}, {'value': '1.03', 'groupId': 'OG005', 'lowerLimit': '0.933', 'upperLimit': '4.05'}, {'value': '1.06', 'groupId': 'OG006', 'lowerLimit': '0.967', 'upperLimit': '4.00'}, {'value': '1.04', 'groupId': 'OG007', 'lowerLimit': '0.917', 'upperLimit': '4.08'}, {'value': '1.45', 'groupId': 'OG008', 'lowerLimit': '1.15', 'upperLimit': '1.75'}]}]}, {'title': 'Serum PF-06460005 (Total Antibody)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.967', 'groupId': 'OG000', 'lowerLimit': '0.950', 'upperLimit': '0.983'}, {'value': '0.974', 'groupId': 'OG001', 'lowerLimit': '0.917', 'upperLimit': '1.03'}, {'value': '0.967', 'groupId': 'OG002', 'lowerLimit': '0.967', 'upperLimit': '0.967'}, {'value': '1.01', 'groupId': 'OG003', 'lowerLimit': '0.983', 'upperLimit': '1.03'}, {'value': '1.08', 'groupId': 'OG004', 'lowerLimit': '0.917', 'upperLimit': '4.02'}, {'value': '1.02', 'groupId': 'OG005', 'lowerLimit': '0.933', 'upperLimit': '3.98'}, {'value': '1.04', 'groupId': 'OG006', 'lowerLimit': '0.967', 'upperLimit': '4.00'}, {'value': '1.04', 'groupId': 'OG007', 'lowerLimit': '0.950', 'upperLimit': '4.08'}, {'value': '1.45', 'groupId': 'OG008', 'lowerLimit': '1.15', 'upperLimit': '1.75'}]}]}, {'title': 'Serum PF-06380101 (Unconjugated Payload)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '25.2', 'upperLimit': '25.4'}, {'value': '24.6', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '25.8'}, {'value': '48.5', 'groupId': 'OG002', 'lowerLimit': '24.8', 'upperLimit': '72.1'}, {'value': '24.6', 'groupId': 'OG003', 'lowerLimit': '23.8', 'upperLimit': '25.4'}, {'value': '24.0', 'groupId': 'OG004', 'lowerLimit': '22.1', 'upperLimit': '71.6'}, {'value': '24.3', 'groupId': 'OG005', 'lowerLimit': '23.0', 'upperLimit': '72.3'}, {'value': '57.9', 'groupId': 'OG006', 'lowerLimit': '23.1', 'upperLimit': '75.9'}, {'value': '69.1', 'groupId': 'OG007', 'lowerLimit': '22.4', 'upperLimit': '73.0'}, {'value': '47.7', 'groupId': 'OG008', 'lowerLimit': '23.8', 'upperLimit': '71.6'}]}]}, {'title': 'Serum PF-06650808 (ADC)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.917', 'groupId': 'OG001', 'lowerLimit': '0.917', 'upperLimit': '0.917'}, {'value': '0.917', 'groupId': 'OG002', 'lowerLimit': '0.917', 'upperLimit': '0.917'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '0.900', 'upperLimit': '1.10'}, {'value': '2.34', 'groupId': 'OG004', 'lowerLimit': '0.933', 'upperLimit': '5.00'}, {'value': '1.03', 'groupId': 'OG005', 'lowerLimit': '0.917', 'upperLimit': '1.07'}, {'value': '2.47', 'groupId': 'OG007', 'lowerLimit': '0.933', 'upperLimit': '4.00'}]}]}, {'title': 'Serum PF-06460005 (Total Antibody)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.917', 'groupId': 'OG001', 'lowerLimit': '0.917', 'upperLimit': '0.917'}, {'value': '0.917', 'groupId': 'OG002', 'lowerLimit': '0.917', 'upperLimit': '0.917'}, {'value': '2.55', 'groupId': 'OG003', 'lowerLimit': '1.10', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '0.933', 'upperLimit': '1.05'}, {'value': '1.05', 'groupId': 'OG005', 'lowerLimit': '0.917', 'upperLimit': '22.1'}, {'value': '0.925', 'groupId': 'OG007', 'lowerLimit': '0.917', 'upperLimit': '0.933'}]}]}, {'title': 'Serum PF-06380101 (Unconjugated Payload)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '23.4', 'upperLimit': '23.4'}, {'value': '24.6', 'groupId': 'OG002', 'lowerLimit': '24.6', 'upperLimit': '24.6'}, {'value': '13.5', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '23.0'}, {'value': '23.5', 'groupId': 'OG004', 'lowerLimit': '21.9', 'upperLimit': '25.2'}, {'value': '46.4', 'groupId': 'OG005', 'lowerLimit': '5.00', 'upperLimit': '70.0'}, {'value': '23.6', 'groupId': 'OG007', 'lowerLimit': '23.1', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4', 'description': 'Tmax of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data as time of first occurrence.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'title': 'Serum PF-06650808 (ADC)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 partipants had reportable parameter values. Individual participant values are 156000 and 105000 ng.hr/mL, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 394000 and 255000 ng.hr/mL, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 515000 and 567000 ng.hr/mL, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1290000 and 1070000 ng.hr/mL, respectively.', 'groupId': 'OG003'}, {'value': '1786000', 'spread': '17', 'groupId': 'OG004'}, {'value': '2147000', 'spread': '33', 'groupId': 'OG005'}, {'value': '3659000', 'spread': '31', 'groupId': 'OG006'}, {'value': '2956000', 'spread': '39', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 4180000 ng.hr/mL.', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06460005 (Total Antibody)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 122000 ng.hr/mL.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 particpants had reportable parameter values. Individual participant values are 371000 and 265000 ng.hr/mL, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 689000 ng.hr/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1290000 and 1070000 ng.hr/mL, respectively.', 'groupId': 'OG003'}, {'value': '2385000', 'spread': '24', 'groupId': 'OG004'}, {'value': '3078000', 'spread': '36', 'groupId': 'OG005'}, {'value': '5116000', 'spread': '31', 'groupId': 'OG006'}, {'value': '3571000', 'spread': '48', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 4270000 ng.hr/mL.', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06380101 (Unconjugated Payload)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 76.300 and 46.600 ng.hr/mL, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 48.900 ng.hr/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 291.000 and 228.000 ng.hr/mL, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 300.000 and 576.000 ng.hr/mL, respectively.', 'groupId': 'OG003'}, {'value': '814.700', 'spread': '96', 'groupId': 'OG004'}, {'value': '671.500', 'spread': '103', 'groupId': 'OG005'}, {'value': '1307.000', 'spread': '19', 'groupId': 'OG006'}, {'value': '1082.000', 'spread': '88', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2060.000 ng.hr/mL.', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06650808 (ADC)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 365000 ng.hr/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 578000 ng.hr/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participants values are 1550000 and 1150000 ng.hr/mL, respectively.', 'groupId': 'OG003'}, {'value': '1690000', 'spread': '18', 'groupId': 'OG004'}, {'value': '1899000', 'spread': '31', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1400000 and 2600000 ng.hr/mL, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Serum PF-06460005 (Total Antibody)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 399000 ng.hr/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 593000 ng.hr/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2130000 and 1720000 ng.hr/mL, respectively.', 'groupId': 'OG003'}, {'value': '2234000', 'spread': '20', 'groupId': 'OG004'}, {'value': '2901000', 'spread': '33', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants reportable parameter values. Individual participant values are 3160000 and 6060000 ng.hr/mL, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Serum PF-06380101 (Unconjugated Payload)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 113.00 ng.hr/mL.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 186.000 ng.hr/mL.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 304.000 and 403.000 ng.hr/mL, respectively.', 'groupId': 'OG003'}, {'value': '507.400', 'spread': '90', 'groupId': 'OG004'}, {'value': '486.600', 'spread': '78', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 273.000 and 2040.000 ng.hr/mL, respectively.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4', 'description': 'Tau refers to the dosing interval, and it equals to 504 hours (3 weeks) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were determined using linear/log trapezoidal method.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 partipants had reportable parameter values. Individual participant values are 0.118 and 0.143 L/hr, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0798 and 0.0808 L/hr, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.106 and 0.0703 L/hr, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0894 and 0.124 L/hr, respectively.', 'groupId': 'OG003'}, {'value': '0.08368', 'spread': '25', 'groupId': 'OG004'}, {'value': '0.07545', 'spread': '26', 'groupId': 'OG005'}, {'value': '0.07924', 'spread': '30', 'groupId': 'OG006'}, {'value': '0.07517', 'spread': '38', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0947 L/hr.', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL was calculated as dose/AUCinf, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. CL was only for PF-06650808 (ADC) and Cycle 1.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.43 and 3.45 L, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 2.71 and 2.87 L, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.51 and 2.20 L, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.39 and 3.81 L, respectively.', 'groupId': 'OG003'}, {'value': '3.428', 'spread': '26', 'groupId': 'OG004'}, {'value': '3.232', 'spread': '28', 'groupId': 'OG005'}, {'value': '3.800', 'spread': '30', 'groupId': 'OG006'}, {'value': '3.481', 'spread': '36', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values is 5.04.', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1', 'description': 'Vss was calculated as dose/(AUCinf × kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Vss was only for PF-06650808 (ADC) and Cycle 1.', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'title': 'Serum PF-06650808 (ADC)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 20.4 and 16.8 hr, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 23.5 and 24.9 hr, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 21.4 and 20.7 hr, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 27.2 and 20.1 hr, respectively.', 'groupId': 'OG003'}, {'value': '29.52', 'spread': '5.2320', 'groupId': 'OG004'}, {'value': '30.72', 'spread': '5.0245', 'groupId': 'OG005'}, {'value': '35.12', 'spread': '4.1282', 'groupId': 'OG006'}, {'value': '32.72', 'spread': '5.1266', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 40.8 hr.', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06460005 (Total Antibody)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 19.1 hr.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 28.7 and 28.7 hr, respectively.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 28.4 hr.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 37.0 and 26.7 hr, respectively.', 'groupId': 'OG003'}, {'value': '33.62', 'spread': '3.4487', 'groupId': 'OG004'}, {'value': '40.93', 'spread': '9.5650', 'groupId': 'OG005'}, {'value': '49.06', 'spread': '13.670', 'groupId': 'OG006'}, {'value': '39.80', 'spread': '9.2477', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 61.1 hr.', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06380101 (Unconjugated Payload)_Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 45.2 and 26.5 hr, respectively.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 40.4 hr.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 50.3 and 39.9 hr, respectively.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 47.5 and 39.4 hr, respectively.', 'groupId': 'OG003'}, {'value': '53.06', 'spread': '6.0260', 'groupId': 'OG004'}, {'value': '53.11', 'spread': '8.5249', 'groupId': 'OG005'}, {'value': '59.18', 'spread': '7.0486', 'groupId': 'OG006'}, {'value': '53.52', 'spread': '3.4434', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 71.8 hr.', 'groupId': 'OG008'}]}]}, {'title': 'Serum PF-06650808 (ADC)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 20.4 hr.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 18.5 hr.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 28.4 and 20.7 hr, respectively.', 'groupId': 'OG003'}, {'value': '28.50', 'spread': '4.9349', 'groupId': 'OG004'}, {'value': '30.33', 'spread': '4.0991', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 30.8 and 35.8 hr, respectively.', 'groupId': 'OG007'}]}]}, {'title': 'Serum PF-06460005 (Total Antibody)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 26.1 hr.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 24.6 hr.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 33.2 and 23.4 hr, respectively', 'groupId': 'OG003'}, {'value': '38.85', 'spread': '3.7108', 'groupId': 'OG004'}, {'value': '40.80', 'spread': '2.5060', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 41.8 and 59.2 hr, respectively', 'groupId': 'OG007'}]}]}, {'title': 'Serum PF-06380101 (Unconjugated Payload)_Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 43.8 hr.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 38.8 hr.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 45.7 and 49.2 hr, respectively.', 'groupId': 'OG003'}, {'value': '52.40', 'spread': '7.9461', 'groupId': 'OG004'}, {'value': '53.83', 'spread': '6.5961', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 48.7 and 61.5 hr, respectively.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4', 'description': 'Terminal elimination half-life was defined as the time measured for the serum concentration to decrease by one half, and calculated as loge(2)/kel.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG001', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG002', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'OG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years', 'description': 'Assays to assess for anti drug (anti PF-06650808) antibodies (ADA) were performed. Positive ADA: titer\\>=1.88.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who received at least 1 dose of study medication and had at least 1 post-dose ADA measurements. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival and Overall Survival (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'timeFrame': '3 years', 'description': 'Progression Free Survival was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of disease progression or to death due to any cause, whichever occurs first. Overall survival was defined as the time from initial dose until death from any cause, and is measured in the intent to treat population.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated prior to the start of dose expansion phase (Part 2).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'FG009', 'title': 'PF-06650808 2.4mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the maximum tolerated dose (MTD). The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '40', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-06650808 0.2 mg/kg (Part 1)', 'description': 'PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG001', 'title': 'PF-06650808 0.4 mg/kg (Part 1)', 'description': 'PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG002', 'title': 'PF-06650808 0.8 mg/kg (Part 1)', 'description': 'PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG003', 'title': 'PF-06650808 1.6 mg/kg (Part 1)', 'description': 'PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG004', 'title': 'PF-06650808 2.0 mg/kg (Part 1)', 'description': 'PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG005', 'title': 'PF-06650808 2.4 mg/kg (Part 1)', 'description': 'PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG006', 'title': 'PF-06650808 3.0 mg/kg (Part 1)', 'description': 'PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG007', 'title': 'PF-06650808 3.6 mg/kg (Part 1)', 'description': 'PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG008', 'title': 'PF-06650808 4.68 mg/kg (Part 1)', 'description': 'PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.'}, {'id': 'BG009', 'title': 'PF-06650808 2.4 mg/kg (Part 2)', 'description': 'Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '69.5', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '55', 'spread': '24', 'groupId': 'BG002'}, {'value': '49.5', 'spread': '2.1', 'groupId': 'BG003'}, {'value': '51.9', 'spread': '14.7', 'groupId': 'BG004'}, {'value': '59.9', 'spread': '9.8', 'groupId': 'BG005'}, {'value': '59.3', 'spread': '13.8', 'groupId': 'BG006'}, {'value': '60.8', 'spread': '4.7', 'groupId': 'BG007'}, {'value': '42', 'spread': '28.3', 'groupId': 'BG008'}, {'value': '57.2', 'spread': '12.5', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '35', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '32', 'groupId': 'BG010'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG010'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline analysis population included all participants who received at least 1 dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-07', 'size': 2209508, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-13T09:13', 'hasProtocol': True}, {'date': '2014-11-17', 'size': 1872455, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-13T09:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'The study was terminated due to a change in sponsor prioritization.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-21', 'studyFirstSubmitDate': '2014-04-30', 'resultsFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2014-04-30', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-21', 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)', 'timeFrame': 'Day 1 up to Day 21', 'description': 'Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting \\>7 days; Febrile neutropenia; Grade\\>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia \\>=72 hours or platelets\\<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade\\>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.'}, {'measure': 'Percentage of Participants With Objective Response (Part 1 and Part 2)', 'timeFrame': 'Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years', 'description': 'Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \\>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)', 'timeFrame': '3 years', 'description': 'AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.'}, {'measure': 'Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)', 'timeFrame': '3 years', 'description': 'Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. The participants who experienced laboratory test abnormalities were determined by investigators.'}, {'measure': 'Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)', 'timeFrame': '3 years', 'description': 'Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus, bicarbonate or carbon dioxide, total protein and lactate dehydrogenase. The participants who experienced laboratory test abnormalities were determined by investigators.'}, {'measure': 'Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2)', 'timeFrame': '3 years', 'description': 'Urinalysis included urine protein. Microscopic analyses were performed if dipstick was abnormal. The participants who experienced laboratory test abnormalities were determined by investigators.'}, {'measure': 'Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)', 'timeFrame': '3 years', 'description': 'Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (\\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\\<) 90 mm Hg; diastolic BP (DBP) \\>=20 mm Hg change from baseline, diastolic \\<50 mm Hg; 2), supine and standing pulse rate \\<40 or greater than (\\>) 120 beats per minute (bpm).'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4', 'description': 'Maximum observed serum concentration (Cmax) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data. PF-06650808 is comprised of an antibody (PF-06460005) and a cytotoxic agent (PF-06380101).'}, {'measure': 'Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4', 'description': 'Tmax of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data as time of first occurrence.'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4', 'description': 'Tau refers to the dosing interval, and it equals to 504 hours (3 weeks) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were determined using linear/log trapezoidal method.'}, {'measure': 'Clearance (CL) (Part 1 and Part 2)', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL was calculated as dose/AUCinf, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. CL was only for PF-06650808 (ADC) and Cycle 1.'}, {'measure': 'Volume of Distribution at Steady State (Vss) (Part 1 and Part 2)', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1', 'description': 'Vss was calculated as dose/(AUCinf × kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Vss was only for PF-06650808 (ADC) and Cycle 1.'}, {'measure': 'Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)', 'timeFrame': 'Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4', 'description': 'Terminal elimination half-life was defined as the time measured for the serum concentration to decrease by one half, and calculated as loge(2)/kel.'}, {'measure': 'Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2)', 'timeFrame': '3 years', 'description': 'Assays to assess for anti drug (anti PF-06650808) antibodies (ADA) were performed. Positive ADA: titer\\>=1.88.'}, {'measure': 'Progression Free Survival and Overall Survival (Part 2)', 'timeFrame': '3 years', 'description': 'Progression Free Survival was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of disease progression or to death due to any cause, whichever occurs first. Overall survival was defined as the time from initial dose until death from any cause, and is measured in the intent to treat population.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['solid tumors', 'triple negative breast cancer', 'PF-06650808', 'Phase 1'], 'conditions': ['Neoplasms', 'Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '30887250', 'type': 'DERIVED', 'citation': 'Rosen LS, Wesolowski R, Baffa R, Liao KH, Hua SY, Gibson BL, Pirie-Shepherd S, Tolcher AW. A phase I, dose-escalation study of PF-06650808, an anti-Notch3 antibody-drug conjugate, in patients with breast cancer and other advanced solid tumors. Invest New Drugs. 2020 Feb;38(1):120-130. doi: 10.1007/s10637-019-00754-y. Epub 2019 Mar 18.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7501001&StudyName=A%20Dose%20Escalation%20Study%20of%20PF-06650808%20in%20Patients%20with%20Advanced%20Solid%20Tumors%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available\n* Previously treated metastatic triple negative breast cancer that expresses Notch3 with at least one measurable lesion\n* Adequate bone marrow, renal and liver function\n\nExclusion Criteria:\n\n* Major surgery, radiation therapy or systemic anti-cancer therapy within 4 weeks of starting study treatment\n* Patients with known symptomatic brain metastases requiring steroids\n* Prior treatment with a compound of the same mechanism'}, 'identificationModule': {'nctId': 'NCT02129205', 'briefTitle': 'A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06650808 IN PATIENTS WITH ADVANCED SOLID TUMORS', 'orgStudyIdInfo': {'id': 'B7501001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-06650808', 'interventionNames': ['Drug: PF-06650808']}], 'interventions': [{'name': 'PF-06650808', 'type': 'DRUG', 'description': 'Dose Escalation Phase \\[Part 1\\] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.', 'armGroupLabels': ['PF-06650808']}, {'name': 'PF-06650808', 'type': 'DRUG', 'description': 'Dose Expansion Phase \\[Part 2\\] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.', 'armGroupLabels': ['PF-06650808']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center, Drug Information Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology/Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Westwood Bowyer Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica - UCLA Medical Center & Orthopaedic Hospital', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology/Oncology - Santa Monica', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University James Cancer Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The OSU Investigational Drug Services', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The OSU Stephanie Spielman Comprehensive Breast Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Martha Morehouse Medical Plaza', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics, LLC (START)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}