Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT01688960
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2012-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2012-09-17', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerable Dose (MTD) or Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'Day 1 to Day 28', 'description': 'Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) administered in combination with aflibercept (ziv-aflibercept) in patients with advanced solid malignancies'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK)', 'timeFrame': 'Day 1 to Day 170', 'description': 'To assess PK parameters such as concentration of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept).'}, {'measure': 'Immunogenicity', 'timeFrame': 'Day 1 to Day 170', 'description': 'To assess the anti-drug antibodies of nesvacumab (REGN910/ SAR307746) and aflibercept (ziv-aflibercept)'}, {'measure': 'Antitumor activity', 'timeFrame': 'Day 1 to Day 170', 'description': 'Objective tumor response according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1'}, {'measure': 'Pharmacodynamics (PD)', 'timeFrame': 'Day 1 to Day 170', 'description': 'Target inhibition biomarker changes, serum tumor markers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria include, but are not limited to, the following:\n\n1. Confirmed diagnosis of solid tumor malignancy\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n3. Adequate hepatic, renal and bone marrow function\n4. Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to, the following:\n\n1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement\n2. Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg\n3. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia\n4. Patients with deep vein thrombosis or pulmonary embolism within last 3 months\n5. Patients with serious non healing wound or acute ulcer\n6. Patients with treatment resistant or bleeding peptic ulcer disease, erosive esophagitis or gastritis, grade 3 or gastrointestinal bleeding/hemorrhage, infectious or inflammatory bowel disease, diverticulitis, or other uncontrolled thromboembolic event within last 3 months\n7. Patients with history of abdominal or tracheal-esophageal fistula\n8. Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors\n9. Prior treatment with bevacizumab within last 6 weeks\n10. Pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT01688960', 'briefTitle': 'Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 1b Study of Combined Angiogenesis Inhibition by Administering REGN910 and Aflibercept (Ziv-aflibercept) in Patients With Advanced Solid Malignancies', 'orgStudyIdInfo': {'id': 'R910-ST-1114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'interventionNames': ['Drug: nesvacumab (REGN910/ SAR307746)', 'Drug: aflibercept (ziv-aflibercept)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'interventionNames': ['Drug: nesvacumab (REGN910/ SAR307746)', 'Drug: aflibercept (ziv-aflibercept)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3a', 'interventionNames': ['Drug: nesvacumab (REGN910/ SAR307746)', 'Drug: aflibercept (ziv-aflibercept)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3b', 'interventionNames': ['Drug: nesvacumab (REGN910/ SAR307746)', 'Drug: aflibercept (ziv-aflibercept)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'interventionNames': ['Drug: nesvacumab (REGN910/ SAR307746)', 'Drug: aflibercept (ziv-aflibercept)']}], 'interventions': [{'name': 'nesvacumab (REGN910/ SAR307746)', 'type': 'DRUG', 'description': 'Dose level 1', 'armGroupLabels': ['Cohort 1']}, {'name': 'nesvacumab (REGN910/ SAR307746)', 'type': 'DRUG', 'description': 'Dose level 2', 'armGroupLabels': ['Cohort 2', 'Cohort 3b']}, {'name': 'nesvacumab (REGN910/ SAR307746)', 'type': 'DRUG', 'description': 'Dose level 3', 'armGroupLabels': ['Cohort 3a', 'Cohort 4']}, {'name': 'aflibercept (ziv-aflibercept)', 'type': 'DRUG', 'otherNames': ['In US: aflibercept is known as ziv-aflibercept'], 'description': 'Dose level 1', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3a']}, {'name': 'aflibercept (ziv-aflibercept)', 'type': 'DRUG', 'otherNames': ['In US: aflibercept is known as ziv-aflibercept'], 'description': 'Dose level 2', 'armGroupLabels': ['Cohort 3b', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Toronto', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}