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NCT01255800 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01255800: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT01255800 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01255800, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in combination with cetuximab in patients with advanced head and neck cancer.
Primary Outcome
Cohorts of 3. The first cohort will receive dose level 1. A full safety evaluation will be conducted after 6 weeks. If 0/3 have a Dose limiting toxicity (DLT), then a new cohort will receive the next dose level. If 1/3 have DLT then 3 more patients will be treated at this dose level. If none has DLT then the next dose level will be administered to the next cohort; otherwise the inferior dose level will be considered the maximum tolerated dose (MTD). If 2/3 have a DLT, then the inferior dose leve
Interventions
- DRUG IPI-926 and Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01255800 record still lists
NCT01255800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which IPI-926 and Cetuximab is the first listed.
NCT01255800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01255800 about?
NCT01255800 is a clinical study titled "Pilot Study of Cetuximab and the Hedgehog Inhibitor IPI-926 in Recurrent Head and Neck Cancer". This study will evaluate the clinical activity of the combination of ipilimumab (IPI) -926 in combination with cetuximab in patients with advanced head and neck cancer.
What is the current status of trial NCT01255800?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01255800?
The interventions under investigation include: IPI-926 and Cetuximab (DRUG).
Who is sponsoring clinical trial NCT01255800?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01255800's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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