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NCT06597565 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC
A Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT06597565: Recruiting Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06597565 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 43 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06597565, a Phase 2 study of Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to determine the activity and safety of ACR-368 (prexasertib) in combination with gemcitabine in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Participants will receive the study drugs ACR-368 and a low dose of gemcitabine once every 2 weeks in 4-week cycles and will continue on treatment unless the disease deteriorates.
Primary Outcome
The overall response rate will be determined by investigator review (IR) and blinded independent central review (BICR).
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG ACR-368
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2024-09-25 |
| Est. Completion | 2028-08-23 |
| Phase | Phase 2 |
What NCT06597565 shows while recruiting
NCT06597565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT06597565 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06597565 about?
NCT06597565 is a clinical study titled "A Phase II Study of ACR-368 and Low Dose Gemcitabine in R/M HNSCC". The purpose of the study is to determine the activity and safety of ACR-368 (prexasertib) in combination with gemcitabine in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Participants will receive the study drugs ACR-368 and a low dose of gemcitabine once every 2 weeks in 4-week c...
What is the current status of trial NCT06597565?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2024-09-25. Estimated completion is 2028-08-23.
What conditions does trial NCT06597565 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT06597565?
The interventions under investigation include: Gemcitabine (DRUG), ACR-368 (DRUG).
Who is sponsoring clinical trial NCT06597565?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06597565 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Squamous Cell Carcinoma
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Where NCT06597565's enrollment target sits among peer trials
43 74th of 124 higher than 49 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma 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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