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NCT01758731 · ClinicalTrials.gov registry record · Phase 1
Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01758731: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT01758731 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01758731, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a research study that plans to learn more about the safety and tolerability of an investigational drug called Olaparib, in combination with radiation therapy and cetuximab. Hypothesis: Intensity modulated radiotherapy with concurrent C225 and Olaparib represents a feasible, biologically-based alternative to standard chemoradiation, with acceptable toxicity, for treatment of locally-advanced HNSCC in patients having a ≥ 10 pack-year smoking history.
Primary Outcome
Maximum tolerated dose (MTD) of Olaparib to be used for Phase II clinical testing.
Interventions
- DRUG Olaparib
- RADIATION Radiation Therapy
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-10-22 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 1 |
What the finished NCT01758731 record still lists
NCT01758731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Olaparib is the first listed.
NCT01758731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01758731 about?
NCT01758731 is a clinical study titled "Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History". This is a research study that plans to learn more about the safety and tolerability of an investigational drug called Olaparib, in combination with radiation therapy and cetuximab. Hypothesis: Intensity modulated radiotherapy with concurrent C225 and Olaparib represents a feasible, biologically-bas...
What is the current status of trial NCT01758731?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2012-10-22. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT01758731?
The interventions under investigation include: Olaparib (DRUG), Radiation Therapy (RADIATION), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT01758731?
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 NCT01758731's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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