Viewing Study NCT00437203

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Ignite Creation Date: 2025-12-24 @ 7:25 PM

Ignite Modification Date: 2025-12-25 @ 5:05 PM

Study NCT ID: NCT00437203

Status: TERMINATED

Last Update Posted: 2012-04-03

First Post: 2007-02-16

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C532366', 'term': 'PF 00477736'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, '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 due to business reasons.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 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'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myoclonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Venoocclusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 + Gemcitabine 750 mg/m^2', 'description': 'PF-00477736 infusion 50 mg, 65 mg or 80 mg IV administered over 3 hrs on Days 1 and 8 of Cycle 0 (21 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle), or PF-00477736 infusion 80 mg, 120 mg, 180 mg, 270 mg or 340 mg IV administered over 24 hrs on Days 1 and 8 of Cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 750 mg/m\\^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 + Gemcitabine 1000 mg/m^2', 'description': 'PF-00477736 infusion 180 mg or 225 mg IV administered over 24 hrs on Days 2 and 9 of each cycle (21 days cycle) along with gemcitabine infusion 1000 mg/m\\^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'MTD could not be determined as study was prematurely terminated.', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 21 Cycle 1', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62', 'description': 'OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(\\>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:\\>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', '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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Trough Concentration (Cmin)', '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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', '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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'paramType': 'MEDIAN', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0', 'description': 'AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]', '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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG006', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'description': 'AUC (0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', '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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}, {'type': 'SECONDARY', 'title': 'Concentration of PF-00477736 in Urine', '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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2)', '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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'paramType': 'MEAN', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}, {'type': 'SECONDARY', 'title': 'Metabolite Profile of PF-00477736 in Plasma and Urine', '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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'OG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'OG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'paramType': 'NUMBER', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'unitOfMeasure': 'percentage of recovered metabolite', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed, as study was terminated due to business reasons.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 milligram (mg) 3 hours (hrs) infusion intravenously (IV) on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg per square meter (mg/m\\^2) 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'FG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'FG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'FG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'FG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'FG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'FG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'FG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'FG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'FG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Objective progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '43', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)', 'description': 'PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'BG001', 'title': 'PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)', 'description': 'PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'BG002', 'title': 'PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)', 'description': 'PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'BG003', 'title': 'PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)', 'description': 'PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'BG004', 'title': 'PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)', 'description': 'PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'BG005', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)', 'description': 'PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'BG006', 'title': 'PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)', 'description': 'PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'BG007', 'title': 'PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)', 'description': 'PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.'}, {'id': 'BG008', 'title': 'PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)', 'description': 'PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'BG009', 'title': 'PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)', 'description': 'PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m\\^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '55.0', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '45.0', 'spread': '3.6', 'groupId': 'BG003'}, {'value': '55.0', 'spread': '11.5', 'groupId': 'BG004'}, {'value': '44.3', 'spread': '12.1', 'groupId': 'BG005'}, {'value': '54.0', 'spread': '8.9', 'groupId': 'BG006'}, {'value': '55.7', 'spread': '4.6', 'groupId': 'BG007'}, {'value': '46.0', 'spread': '6.9', 'groupId': 'BG008'}, {'value': '49.5', 'spread': '7.1', 'groupId': 'BG009'}, {'value': '53.7', 'spread': '10.7', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '23', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '20', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-06', 'studyFirstSubmitDate': '2007-02-16', 'resultsFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2007-02-16', 'lastUpdatePostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-06', 'studyFirstPostDateStruct': {'date': '2007-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine', 'timeFrame': 'Up to Day 21 Cycle 1'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Objective Response (OR)', 'timeFrame': 'Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62', 'description': 'OR based assessment of confirmed complete response(CR)/confirmed partial response(PR)/stable disease(SD)/progressive disease(PD) as per Response Evaluation Criteria in Solid Tumors(RECIST).CR:disappearance of target lesions;PR:at least(\\>=) 30% decrease in sum of longest dimensions of target lesions(reference:baseline sum of longest dimensions);PD:\\>=20% increase in sum of longest dimensions of target lesions(reference:smallest sum of longest dimensions recorded since treatment started)/appearance of any new lesions;SD:no adequate shrinkage to qualify for PR/adequate increase to qualify for PD.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin)', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0', 'description': 'AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-48)]', 'timeFrame': '0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'description': 'AUC (0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).'}, {'measure': 'Concentration of PF-00477736 in Urine', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Metabolite Profile of PF-00477736 in Plasma and Urine', 'timeFrame': '0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced cancer'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of PF-00477736 that can be safely given in combination with gemcitabine. This is the first study of PF-00477736 in humans.', 'detailedDescription': 'The study was closed to enrollment as of 17 May 2010 due to business reasons. The patient on study continued treatment until 19 April 2011 when stopped for complete response. Premature closure was not prompted by any safety or efficacy concerns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytopathological diagnosis of solid malignancy that is refractory to standard therapy or for which no curative therapy exists.\n* ECOG performance status 0 or 1.\n* Adequate blood cell counts, kidney function and liver function.\n\nExclusion Criteria:\n\n* Prior treatment with gemcitabine.\n* Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.\n* NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis.\n* NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC Grade 3 hypertension that is well controlled.\n* Known human immunodeficiency virus (HIV) seropositivity.\n* Concurrent treatment with anticoagulants or known coagulopathy'}, 'identificationModule': {'nctId': 'NCT00437203', 'briefTitle': 'PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies', 'orgStudyIdInfo': {'id': 'A8211001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: PF-00477736', 'Drug: gemcitabine']}], 'interventions': [{'name': 'PF-00477736', 'type': 'DRUG', 'description': '* Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).\n* If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion.', 'armGroupLabels': ['1']}, {'name': 'gemcitabine', 'type': 'DRUG', 'description': 'gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-6984', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}