A Study of IMC-A12 Every 2 Weeks in Patients With Tumors Who No Longer Respond to Treatment or No Treatment is Available
Phase 1
Completed
- Conditions
- Advanced Solid Tumors
- Registration Number
- NCT00785941
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to determine if IMC-A12 is safe for patients, and also to determine the best dose of IMC-A12 to give to patients.
- Detailed Description
The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-IGF-IR monoclonal antibody IMC-A12 administered every other week in patients with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) 8 weeks Maximum Tolerated Dose 8 weeks
- Secondary Outcome Measures
Name Time Method Half-life (t 1/2), cohorts 1, 2, 3, 4, and 5 8 weeks Maximum concentration (Cmax), cohorts 1, 2, 3, 4, and 5 8 weeks Minimum concentration (Cmin), cohorts 1, 2, 3, 4, and 5 8 weeks Area under concentration (AUC), cohorts 1, 2, 3, 4, and 5 8 weeks Clearance (Cl) rate drug is completely removed, cohorts 1, 2, 3, 4, and 5 8 weeks Volume of distribution (Vss) at steady state, cohorts 1, 2, 3, 4, and 5 8 weeks Serum Anti-IMC-A12 Antibody Assessment (immunogenicity) 8 weeks Change in tumor size from Baseline Measurement 8 weeks
Trial Locations
- Locations (1)
ImClone Investigational Site
🇺🇸Nashville, Tennessee, United States
ImClone Investigational Site🇺🇸Nashville, Tennessee, United States