Solid Tumors Clinical Trial
Official title:
A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.
Status | Completed |
Enrollment | 53 |
Est. completion date | May 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Confirmed diagnosis of advanced solid malignancy. 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: 1. Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Regeneron Pharmaceuticals | Sanofi |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies | 28 days | Yes | |
Secondary | PK/PD profile | 28 days | No | |
Secondary | Immunogenicity | 28 days | Yes | |
Secondary | Anti-tumor activity | 28 days | No | |
Secondary | Correlative biomarkers | 28 days | No |
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