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NCT01160458 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01160458: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01160458 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160458, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Interventions
- DRUG IMC-A12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-06-02 |
| Est. Completion | 2017-02-24 |
| Phase | Phase 2 |
What the finished NCT01160458 record still lists
NCT01160458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which IMC-A12 is the first listed.
NCT01160458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01160458 about?
NCT01160458 is a clinical study titled "Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy". 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 respon...
What is the current status of trial NCT01160458?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2010-06-02. Estimated completion is 2017-02-24.
What interventions are being tested in trial NCT01160458?
The interventions under investigation include: IMC-A12 (DRUG).
Who is sponsoring clinical trial NCT01160458?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01160458's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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