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
• Interventions: Biological: IMC-A12

• 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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-10
• Study Completion: 2007-11
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-12
• Last Update Posted: 2011-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMC-A12	IMC-A12	All patients will receive intravenous infusions of IMC-A12, with the dose depending on which cohort they are enrolled into a minimum of three patients will be enrolled in each Cohort. When all patients complete a cohort, dose escalation to the next Cohort will occur. A treatment cycle will consist of IMC-A12 administered intravenously, once every other week for 4 weeks, for a total of 2 doses; followed by a 2-week observation period.

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