Study of Nesvacumab (REGN910/ SAR307746)
This study is currently recruiting participants.
Verified May 2013 by Regeneron Pharmaceuticals
Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01271972
First received: January 5, 2011
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: nesvacumab (REGN910/ SAR307746) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies |
Resource links provided by NLM:
Further study details as provided by Regeneron Pharmaceuticals:
Primary Outcome Measures:
- Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- PK/PD profile [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Immunogenicity [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Anti-tumor activity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Correlative biomarkers [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Dose 1
|
Drug: nesvacumab (REGN910/ SAR307746) |
|
Experimental: Cohort 2
Dose 2
|
Drug: nesvacumab (REGN910/ SAR307746) |
|
Experimental: Cohort 3
Dose 3
|
Drug: nesvacumab (REGN910/ SAR307746) |
|
Experimental: Cohort 4
Dose 4
|
Drug: nesvacumab (REGN910/ SAR307746) |
|
Experimental: Cohort 5
Dose 5
|
Drug: nesvacumab (REGN910/ SAR307746) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed diagnosis of advanced solid malignancy.
- ECOG performance status 0 - 1
- Adequate hepatic, renal and bone marrow function
- At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy
- At least 6 weeks since last dose of bevacizumab
- At least 4 weeks since last surgery
- At least 4 weeks since last dose of investigational treatment
Exclusion Criteria:
- Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
- Patients with serious non healing wound or acute ulcer
- Either systolic blood pressure >150 mm Hg or diastolic blood pressure >95 mm Hg
- Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
- Patients with deep vein thrombosis or pulmonary embolism within last 6 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271972
Contacts
| Contact: Clinical Trials Administrator | clinicaltrials@regeneron.com |
Locations
| United States, California | |
| Recruiting | |
| San Francisco, California, United States | |
| United States, Texas | |
| Recruiting | |
| San Antonio, Texas, United States | |
| Canada, Ontario | |
| Recruiting | |
| Toronto, Ontario, Canada | |
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01271972 History of Changes |
| Other Study ID Numbers: | R910-ST-1010 |
| Study First Received: | January 5, 2011 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
ClinicalTrials.gov processed this record on May 23, 2013