Study of Nesvacumab (REGN910/ SAR307746)
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | January 2011 |
| End Date: | July 2014 |
| Contact: | Clinical Trials Administrator |
| Email: | clinicaltrials@regeneron.com |
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.
SAR307746) administered IV every 2 weeks.
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
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