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NCT04169074 · ClinicalTrials.gov registry record · Phase 2
Immune Modulation by Abemaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC). (AIM Trial)
A Phase 2 study, sponsored by University of Arizona.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT04169074: Clinical Trial Phase 2 study, sponsored by University of Arizona.
NCT04169074 is a Phase 2 study that was terminated before completion, run by University of Arizona. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04169074, a Phase 2 study, was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a Phase II single-arm window trial to assess the clinical and biological effects of neoadjuvant abemaciclib in patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).
Primary Outcome
To evaluate the clinical activity of abemaciclib in patients with operable, HPV-negative HNSCC as measured by quantitative change in tumor size (∆T) following 10-21 (+7) days of neoadjuvant exposure. ∆T will be measured as a continuous variable, based upon the percent change in RECIST v1.1 metrics for index lesions. Index lesions will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumor (RECIST) Committee.
Interventions
- DRUG Abemaciclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-07-07 |
| Est. Completion | 2025-01-13 |
| Phase | Phase 2 |
Why NCT04169074 stopped before completion
NCT04169074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Abemaciclib is the first listed.
NCT04169074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04169074 about?
NCT04169074 is a clinical study titled "Immune Modulation by Abemaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC). (AIM Trial)". This is a Phase II single-arm window trial to assess the clinical and biological effects of neoadjuvant abemaciclib in patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).
What is the current status of trial NCT04169074?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2021-07-07. Estimated completion is 2025-01-13.
What interventions are being tested in trial NCT04169074?
The interventions under investigation include: Abemaciclib (DRUG).
Who is sponsoring clinical trial NCT04169074?
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 NCT04169074's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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