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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 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.

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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.

Conditions Studied

Head and Neck Squamous Cell Carcinoma

Interventions

  • DRUG Gemcitabine
  • DRUG ACR-368

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2024-09-25
Est. Completion 2028-08-23
Phase Phase 2

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

502 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06597565

The ClinicalTrials.gov registry entry for NCT06597565 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (63% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.