Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies
NCT ID: NCT01688960
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2012-10-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
nesvacumab (REGN910/ SAR307746)
Dose level 1
aflibercept (ziv-aflibercept)
Dose level 1
Cohort 2
nesvacumab (REGN910/ SAR307746)
Dose level 2
aflibercept (ziv-aflibercept)
Dose level 1
Cohort 3a
nesvacumab (REGN910/ SAR307746)
Dose level 3
aflibercept (ziv-aflibercept)
Dose level 1
Cohort 3b
nesvacumab (REGN910/ SAR307746)
Dose level 2
aflibercept (ziv-aflibercept)
Dose level 2
Cohort 4
nesvacumab (REGN910/ SAR307746)
Dose level 3
aflibercept (ziv-aflibercept)
Dose level 2
Interventions
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nesvacumab (REGN910/ SAR307746)
Dose level 1
nesvacumab (REGN910/ SAR307746)
Dose level 2
nesvacumab (REGN910/ SAR307746)
Dose level 3
aflibercept (ziv-aflibercept)
Dose level 1
aflibercept (ziv-aflibercept)
Dose level 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
3. Adequate hepatic, renal and bone marrow function
4. Resolution of toxicity from prior therapy (except alopecia) to grade less than or equal to 1
Exclusion Criteria
2. Either systolic BP greater than 140 mm Hg or diastolic BP greater than 90 mm Hg
3. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
4. Patients with deep vein thrombosis or pulmonary embolism within last 3 months
5. Patients with serious non healing wound or acute ulcer
6. 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
7. Patients with history of abdominal or tracheal-esophageal fistula
8. Prior treatment with aflibercept (ziv-aflibercept), Ang2 or Tie2 inhibitors
9. Prior treatment with bevacizumab within last 6 weeks
10. Pregnant or breast-feeding women
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Indianapolis, Indiana, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
San Antonio, Texas, United States
Toronto, , Canada
Countries
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Other Identifiers
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R910-ST-1114
Identifier Type: -
Identifier Source: org_study_id
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