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NCT01287130 · ClinicalTrials.gov registry record · Phase 1
AZD6244 With Cetuximab for Solid Tumors and Colorectal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01287130: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01287130 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01287130, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: \- The experimental cancer treatment drug AZD6244 has been shown to block signals that tell cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon, and rectum, also blocks signals that tell cancer cells to grow. Researchers are investigating the highest safe dose of AZD6244 to give with cetuximab, and will also investigate the effectiveness of this drug combination in individuals who have colorectal cancer that involves a particular protein known as the K-RAS protein. Cetuximab is not used to treat colorectal cancer with K-RAS tumors because it has not been shown to be effective, but researchers believe that adding AZD6244 to cetuximab may improve how well cetuximab works, even in people with K-RAS tumors. Objectives: * To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for solid tumors that have not responded to standard treatment. * To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for colorectal cancer that involves the K-RAS protein and has not responded to standard treatment. Eligibility: * Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatment. * Individuals at least 18 years of age who have been diagnosed with colorectal cancer that has not responded to standard treatment. Design: * This protocol will involve two separate studies: an initial study to establish the highest safe and effective dose of AZD6244 and cetuximab in individuals with solid tumors, and an expansion study of AZD6244 and cetuximab in individuals with colorectal cancer involving the K-RAS protein. * Participants will be screened with a full medical history and physical examination, blood samples, imaging studies, and other tests as required by the researchers. * AZD6244 is a capsule to be swallowed once or twice a day, every day, with water on an empty stomach. Cetuximab will be given intravenously once a w
Interventions
- DRUG Cetuximab
- DRUG AZD6244
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-01-07 |
| Est. Completion | 2013-08-27 |
| Phase | Phase 1 |
What the finished NCT01287130 record still lists
NCT01287130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT01287130 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01287130 about?
NCT01287130 is a clinical study titled "AZD6244 With Cetuximab for Solid Tumors and Colorectal Cancer". Background: \- The experimental cancer treatment drug AZD6244 has been shown to block signals that tell cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon, and rectum, also blocks signals that tell cancer cells to grow. Researchers are investigating the highes...
What is the current status of trial NCT01287130?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-01-07. Estimated completion is 2013-08-27.
What interventions are being tested in trial NCT01287130?
The interventions under investigation include: Cetuximab (DRUG), AZD6244 (DRUG).
Who is sponsoring clinical trial NCT01287130?
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 NCT01287130's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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