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
53 participants
INTERVENTIONAL
2011-01-31
2015-05-31
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
Dose 1
nesvacumab (REGN910/ SAR307746)
Cohort 2
Dose 2
nesvacumab (REGN910/ SAR307746)
Cohort 3
Dose 3
nesvacumab (REGN910/ SAR307746)
Cohort 4
Dose 4
nesvacumab (REGN910/ SAR307746)
Cohort 5
Dose 5
nesvacumab (REGN910/ SAR307746)
Expansion Cohort 1
Dose 4
nesvacumab (REGN910/ SAR307746)
Expansion Cohort 2
Dose 5
nesvacumab (REGN910/ SAR307746)
Interventions
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nesvacumab (REGN910/ SAR307746)
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0 - 1
3. Adequate hepatic, renal and bone marrow function
4. At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy
5. At least 6 weeks since last dose of bevacizumab
6. At least 4 weeks since last surgery
7. At least 4 weeks since last dose of investigational treatment
Exclusion Criteria
2. Patients with serious non healing wound or acute ulcer
3. Either systolic blood pressure \>150 mm Hg or diastolic blood pressure \>95 mm Hg
4. Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
5. Patients with deep vein thrombosis or pulmonary embolism within last 6 months
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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San Francisco, California, United States
San Antonio, Texas, United States
Toronto, Ontario, Canada
Countries
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Other Identifiers
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R910-ST-1010
Identifier Type: -
Identifier Source: org_study_id
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