CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
IMC-A12drug
Likely dose
IMC-A12 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01160458
NCT01160458Phase 2Completed

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

National Cancer Institute (NCI)·interventional·Posted Jul 12, 2010·Updated Apr 10, 2018

In Brief

A Phase 2 clinical trial evaluating IMC-A12 for Pleural Mesothelioma and Peritoneal Mesothelioma. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Background: Background: \- IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration, is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide. Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy. Objectives: \- To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy. Design: * Eligible participants will be screened with a full physical examination and medical history, blood and urine samples, and imaging studies. * Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be evaluated before the start of each new cycle with blood tests and imaging studies if needed. * Treatment cycles will continue for as long as needed, unless severe side effects develop or the disease progresses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2010
Enrollment StartJun 2, 2010
Primary CompletionAug 13, 2016
Study CompletionFeb 24, 2017
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 16.0 years ago

Interventions

IMC-A12drug

20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)