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NCT03601507 · ClinicalTrials.gov registry record · Phase 2
Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer
A Phase 2 study, sponsored by University of Arizona.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03601507: Clinical Trial Phase 2 study, sponsored by University of Arizona.
NCT03601507 is a Phase 2 study that was terminated before completion, run by University of Arizona. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03601507, a Phase 2 study, was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This phase II trial studies how well alpelisib works in treating participants with human papillomavirus(HPV)-associated stage I-IVA head and neck cancer that can be removed by surgery. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Measurable index lesions on paired, pre-and post-treatment computed tomography scans (delta change in T) with size treated as a continuous variable. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD) is the sum of target lesions have increased by \>=20% and \>
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Therapeutic Conventional Surgery
- DRUG Alpelisib
- OTHER Pharmacodynamic Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-03-11 |
| Est. Completion | 2022-05-24 |
| Phase | Phase 2 |
Why NCT03601507 stopped before completion
NCT03601507 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03601507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03601507 about?
NCT03601507 is a clinical study titled "Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer". This phase II trial studies how well alpelisib works in treating participants with human papillomavirus(HPV)-associated stage I-IVA head and neck cancer that can be removed by surgery. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT03601507?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2019-03-11. Estimated completion is 2022-05-24.
What interventions are being tested in trial NCT03601507?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Alpelisib (DRUG), Pharmacodynamic Study (OTHER).
Who is sponsoring clinical trial NCT03601507?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03601507's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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