Viewing Study NCT01647828

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Ignite Creation Date: 2025-12-26 @ 10:32 AM
Ignite Modification Date: 2025-12-31 @ 7:43 PM
Study NCT ID: NCT01647828
Status: COMPLETED
Last Update Posted: 2023-02-15
First Post: 2012-07-11
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
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': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606143', 'term': 'tarextumab'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}], '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'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'imran.chaudhry@oncomed.com', 'phone': '6509958322', 'title': 'Manager, Regulatory Affairs', 'organization': 'OncoMed Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From date of first dose to date of last dose plus 30 days (up to approximately 17 months)', 'description': "An adverse event was defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the participant's participation in the research, whether or not considered related to the subject's participation in the research.\n\nThe Safety Population comprised all participants who received at least 1 partial dose of tarextumab or placebo.", 'eventGroups': [{'id': 'EG000', 'title': 'P1B: OMP-59R5 2.5 mg/kg + Gem', 'description': 'Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'P1B: OMP-59R5 5 mg/kg + Gem', 'description': 'Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'P1B: OMP-59R5 5 mg/kg + Nab-P + Gem', 'description': 'Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem', 'description': 'Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'P1B: OMP-59R5 10 mg/kg + Nab-P + Gem', 'description': 'Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 6, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem', 'description': 'Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'P1B: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 10, 'seriousNumAffected': 9}, {'id': 'EG007', 'title': 'P2: Placebo + Nab-P + Gem', 'description': 'Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 88, 'otherNumAffected': 85, 'seriousNumAtRisk': 85, 'deathsNumAffected': 60, 'seriousNumAffected': 51}, {'id': 'EG008', 'title': 'P2: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 89, 'otherNumAffected': 87, 'seriousNumAtRisk': 87, 'deathsNumAffected': 71, 'seriousNumAffected': 58}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 38}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 46}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 42}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 41}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 71}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 47}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 32}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 26}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 21}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Gastrooesphageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 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{'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 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[{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'P1B: OMP-59R5 2.5 mg/kg + Gem', 'description': 'Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'OG001', 'title': 'P1B: OMP-59R5 5 mg/kg + Gem', 'description': 'Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'OG002', 'title': 'P1B: OMP-59R5 5 mg/kg + Nab-P + Gem', 'description': 'Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'OG003', 'title': 'P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem', 'description': 'Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'OG004', 'title': 'P1B: OMP-59R5 10 mg/kg + Nab-P + Gem', 'description': 'Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'OG005', 'title': 'P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem', 'description': 'Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'OG006', 'title': 'P1B: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year in absence of unacceptable toxicity or disease progression.', 'description': 'Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT Evaluable Population comprised all participants who received at least 1 partial dose of tarextumab during the Phase 1b dose escalation portion of the study (enrolled before the MTD was determined) and who completed Day 15 of Cycle 1 tarextumab administration or discontinued due to drug-related toxicity.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Overall Survival (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'P2: Placebo + Nab-P + Gem', 'description': 'Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'OG001', 'title': 'P2: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}], 'classes': [{'title': 'Number of subjects who died', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Number of subjects who did not die', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year in absence of unacceptable toxicity or disease progression.', 'description': 'To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phase 2: Median OS by Notch 3 Percentile (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'P2: Placebo + Nab-P + Gem', 'description': 'Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'OG001', 'title': 'P2: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}], 'classes': [{'title': 'Notch 3 ≥ 75th percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '187.5', 'comment': 'Upper 95% CI was not reached', 'groupId': 'OG000', 'lowerLimit': '95.0', 'upperLimit': 'NA'}, {'value': '228.0', 'groupId': 'OG001', 'lowerLimit': '101.0', 'upperLimit': '453.0'}]}]}, {'title': 'Notch 3 ≥ 50th percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '220.5', 'groupId': 'OG000', 'lowerLimit': '135.0', 'upperLimit': '329.0'}, {'value': '151.0', 'groupId': 'OG001', 'lowerLimit': '101.0', 'upperLimit': '258.0'}]}]}, {'title': 'Notch 3 ≥ 25th percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '206.0', 'groupId': 'OG000', 'lowerLimit': '146.0', 'upperLimit': '312.0'}, {'value': '165.0', 'groupId': 'OG001', 'lowerLimit': '123.0', 'upperLimit': '252.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 1 year in absence of unacceptable toxicity or disease progression.', 'description': 'To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population comprised all participants who received at least 1 partial dose of tarextumab. Here, Overall Number of Participants Analyzed = number of participants with Notch 3 ≥ 25th percentile, and Number Analyzed = number of participants in each Notch 3 percentile subset.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'P1B: OMP-59R5 2.5 mg/kg + Gem', 'description': 'Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'FG001', 'title': 'P1B: OMP-59R5 5 mg/kg + Gem', 'description': 'Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'FG002', 'title': 'P1B: OMP-59R5 5 mg/kg + Nab-P + Gem', 'description': 'Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'FG003', 'title': 'P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem', 'description': 'Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'FG004', 'title': 'P1B: OMP-59R5 10 mg/kg + Nab-P + Gem', 'description': 'Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'FG005', 'title': 'P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem', 'description': 'Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'FG006', 'title': 'P1B: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'FG007', 'title': 'P2: Placebo + Nab-P + Gem', 'description': 'Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'FG008', 'title': 'P2: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '88'}, {'groupId': 'FG008', 'numSubjects': '89'}]}, {'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'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '88'}, {'groupId': 'FG008', 'numSubjects': '89'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '71'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}]}, {'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': '1'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', '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': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Phase 1b: A total of 40 subjects were planned and enrolled. Phase 2: Approximately 160 subjects were planned to be randomized. A total of 177 subjects were enrolled/randomized.\n\nTotal: 217 subjects were enrolled/randomized (Phase 1b and Phase 2)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '88', 'groupId': 'BG007'}, {'value': '89', 'groupId': 'BG008'}, {'value': '217', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'P1B: OMP-59R5 2.5 mg/kg + Gem', 'description': 'Cohort 1: Subjects receive OMP-59R5 2.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG001', 'title': 'P1B: OMP-59R5 5 mg/kg + Gem', 'description': 'Cohort 2: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG002', 'title': 'P1B: OMP-59R5 5 mg/kg + Nab-P + Gem', 'description': 'Cohort 3: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG003', 'title': 'P1B: OMP-59R5 7.5 mg/kg + Nab-P + Gem', 'description': 'Cohort 4: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG004', 'title': 'P1B: OMP-59R5 10 mg/kg + Nab-P + Gem', 'description': 'Cohort 5: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG005', 'title': 'P1B: OMP-59R5 12.5 mg/kg + Nab-P + Gem', 'description': 'Cohort 6: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG006', 'title': 'P1B: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Expansion Cohort: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG007', 'title': 'P2: Placebo + Nab-P + Gem', 'description': 'Placebo Arm: Subjects receive placebo (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG008', 'title': 'P2: OMP-59R5 15 mg/kg + Nab-P + Gem', 'description': 'Active Arm: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 and Day 15 of each 28-day treatment cycle) along with 125 mg/m2 Nab-Paclitaxel (Day 1, Day 8, and Day 15 of every 28-day treatment cycle) and 1000 mg/mg2 of Gemcitabine (Day 1, Day 8, and Day 15 of every 28-day treatment cycle).'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '75'}, {'value': '68', 'groupId': 'BG001', 'lowerLimit': '61', 'upperLimit': '84'}, {'value': '68', 'groupId': 'BG002', 'lowerLimit': '55', 'upperLimit': '76'}, {'value': '66', 'groupId': 'BG003', 'lowerLimit': '55', 'upperLimit': '79'}, {'value': '67', 'groupId': 'BG004', 'lowerLimit': '49', 'upperLimit': '83'}, {'value': '58', 'groupId': 'BG005', 'lowerLimit': '41', 'upperLimit': '70'}, {'value': '59', 'groupId': 'BG006', 'lowerLimit': '45', 'upperLimit': '76'}, {'value': '66', 'groupId': 'BG007', 'lowerLimit': '40', 'upperLimit': '82'}, {'value': '66', 'groupId': 'BG008', 'lowerLimit': '34', 'upperLimit': '88'}, {'value': '66', 'groupId': 'BG009', 'lowerLimit': '34', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '34', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}, {'value': '91', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '54', 'groupId': 'BG007'}, {'value': '50', 'groupId': 'BG008'}, {'value': '126', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '81', 'groupId': 'BG007'}, {'value': '87', 'groupId': 'BG008'}, {'value': '204', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '17', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '80', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}, {'value': '191', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat Population: All patients who met eligibility requirements and gave written informed consent.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2012-07-11', 'resultsFirstSubmitDate': '2018-03-12', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-19', 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Ib: Number of Participants With Dose-limiting Toxicities (DLT)', 'timeFrame': 'Up to 1 year in absence of unacceptable toxicity or disease progression.', 'description': 'Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).'}, {'measure': 'Phase 2: Overall Survival (ITT Population)', 'timeFrame': 'Up to 1 year in absence of unacceptable toxicity or disease progression.', 'description': 'To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer.'}, {'measure': 'Phase 2: Median OS by Notch 3 Percentile (ITT Population)', 'timeFrame': 'Up to 1 year in absence of unacceptable toxicity or disease progression.', 'description': 'To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Newly diagnosed Stage IV Pancreatic Cancer'], 'conditions': ['Stage IV Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '31347292', 'type': 'DERIVED', 'citation': "Hu ZI, Bendell JC, Bullock A, LoConte NK, Hatoum H, Ritch P, Hool H, Leach JW, Sanchez J, Sohal DPS, Strickler J, Patel R, Wang-Gillam A, Firdaus I, Yu KH, Kapoun AM, Holmgren E, Zhou L, Dupont J, Picozzi V, Sahai V, O'Reilly EM. A randomized phase II trial of nab-paclitaxel and gemcitabine with tarextumab or placebo in patients with untreated metastatic pancreatic cancer. Cancer Med. 2019 Sep;8(11):5148-5157. doi: 10.1002/cam4.2425. Epub 2019 Jul 26."}]}, 'descriptionModule': {'briefSummary': 'The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage IV pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet all of the following major inclusion criteria to be eligible for the study:\n\n1. 18 years of age or older\n2. Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas.\n3. Performance Status (ECOG) 0 or 1\n4. FFPE tumor tissue from metastatic site(s\n5. Adequate organ function\n6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation.\n7. For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration.\n8. Male subjects must be surgically sterile or must agree to use physician-approved contraception from 30 days prior to the first study drug administration to 30 days following the last study drug administration.\n\nExclusion Criteria:\n\nSubjects who meet any of the following major exclusion criteria will not be eligible for participation in the study:\n\n1. Neuroendocrine tumors (i.e., carcinoid, islet cell cancer) of the pancreas.\n2. Known brain metastases.\n3. Prior therapy, including systemic therapy, surgical resection or radiation for newly diagnosed stage IV pancreatic cancer.\n4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).\n5. Any disorder that would significantly compromise protocol compliance.\n6. Prior non-pancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery and/or radiotherapy alone must be in remission ≥3 years. The following prior malignancies are allowable irrespective of when they occurred: in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic skin cancer.\n7. Known human immunodeficiency virus (HIV) infection.\n8. Females who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT01647828', 'acronym': 'ALPINE', 'briefTitle': 'A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mereo BioPharma'}, 'officialTitle': 'A Phase 1b/2 Study of OMP-59R5 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer', 'orgStudyIdInfo': {'id': '59R5-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OMP-59R5 plus Gemcitabine and Nab-Paclitaxel', 'description': 'OMP-59R5 plus Gemcitabine and Nab-Paclitaxel', 'interventionNames': ['Drug: OMP-59R5', 'Drug: Gemcitabine', 'Drug: Nab-Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcitabine and Nab-Paclitaxel plus Placebo', 'description': 'Gemcitabine and Nab-Paclitaxel plus Placebo', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Placebo', 'Drug: Nab-Paclitaxel']}], 'interventions': [{'name': 'OMP-59R5', 'type': 'DRUG', 'description': 'OMP-59R5 administered intravenously', 'armGroupLabels': ['OMP-59R5 plus Gemcitabine and Nab-Paclitaxel']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'administered intravenously', 'armGroupLabels': ['Gemcitabine and Nab-Paclitaxel plus Placebo', 'OMP-59R5 plus Gemcitabine and Nab-Paclitaxel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'administered IV', 'armGroupLabels': ['Gemcitabine and Nab-Paclitaxel plus Placebo']}, {'name': 'Nab-Paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane'], 'description': 'administered intravenously', 'armGroupLabels': ['Gemcitabine and Nab-Paclitaxel plus Placebo', 'OMP-59R5 plus Gemcitabine and Nab-Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85338', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Western Regional Medical Center, Inc.', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St Jude Heritage Healthcare Virginia K. 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