Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)
Phase 2
Terminated
- Conditions
- Renal Cell CarcinomaMetastases
- Interventions
- Registration Number
- NCT00100685
- Lead Sponsor
- Abbott
- Brief Summary
This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 2 Volociximab (anti-α5β1 integrin monoclonal antibody) Volociximab administered intravenously at a dose of 15 mg/kg qwk Arm 1 Volociximab (anti-α5β1 integrin monoclonal antibody) Volociximab administered intravenously at a dose of 10 mg/kg qowk
- Primary Outcome Measures
Name Time Method The proportion of patients with a confirmed tumor response at any time during the study Any time during the study
- Secondary Outcome Measures
Name Time Method Duration of tumor response Up to 104 weeks Time to disease progression Up to 104 weeks Pharmacokinetics (PK) of M200 Day 0 through Study Termination Immunogenicity Day 0 through Study Termination
Trial Locations
- Locations (3)
Site Reference ID/Investigator# 70400
🇺🇸Los Angeles, California, United States
Site Reference ID/Investigator# 70399
🇺🇸Cleveland, Ohio, United States
Site Reference ID/Investigator# 70401
🇺🇸New York, New York, United States