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NCT01283334 · ClinicalTrials.gov registry record · Phase 1
A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01283334: Completed Phase 1 study, sponsored by Emory University.
NCT01283334 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01283334, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to test the drug RAD001 in combination with other chemotherapy drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination. The investigators will test the safety of RAD001 in combination with Carboplatin and Cetuximab and see what effects (good and/or bad) it has on your cancer, and find the highest dose of RAD001 that can be given without causing bad side effects. The doses of Carboplatin and Cetuximab will not be varied as both these drugs are considered to be part of the current standard of care for patients with your condition.
Primary Outcome
This phase 1 clinical trial used a standard 3 + 3 design. Four dose levels of everolimus were planned to be evaluated, and the standard 3 + 3 design with dose de-escalation was used in the trial. Namely, 3 patients were assigned to starting dose level 1. If no dose-limiting toxicity (DLT) was observed, the trial proceeded to the next dose level, and another cohort of 3 patients was enrolled. If at least 2 of the 3 patients experienced at least 1 DLT, then the dose level decreased; otherwise, if
Interventions
- DRUG Carboplatin
- DRUG Cetuximab
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01283334 record still lists
NCT01283334 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT01283334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01283334 about?
NCT01283334 is a clinical study titled "A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer". The purpose of this study is to test the drug RAD001 in combination with other chemotherapy drugs, Carboplatin and Cetuximab. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination. The investigators will test the safety of RAD0...
What is the current status of trial NCT01283334?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-01. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01283334?
The interventions under investigation include: Carboplatin (DRUG), Cetuximab (DRUG), RAD001 (DRUG).
Who is sponsoring clinical trial NCT01283334?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01283334's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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