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Anti-cancer agent

ACR-368 + Gemcitabine for Head and Neck Cancer

Phase 2

Recruiting

Led By Christine Chung, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see how well ACR-368 (prexasertib) works with gemcitabine in patients with Head and Neck Squamous Cell Carcinoma. Patients will receive

Who is the study for?

This trial is for individuals with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). Participants should not have had previous chemotherapy for their recurrent/metastatic disease, must be able to receive medication intravenously, and have measurable disease as per RECIST criteria. Key exclusions include prior treatment with ACR-368 or gemcitabine in the metastatic setting, active infections, significant cardiovascular disease, or other serious medical conditions.

What is being tested?

The study is testing the effectiveness and safety of a combination therapy: ACR-368 (prexasertib) alongside low dose gemcitabine. Patients will be treated every two weeks over four-week cycles. The goal is to see how well this combo works against HNSCC compared to standard treatments.

What are the potential side effects?

Potential side effects may include fatigue, nausea, hair loss from gemcitabine; increased risk of infection due to lowered white blood cell counts; and possible liver enzyme changes. Side effects specific to ACR-368 are not detailed but could overlap with those known from similar drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate: Cohort A

Overall Response Rate: Cohort B

Secondary study objectives

Duration of response (DOR)

Overall Survival (OS)

Progression Free Survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B (p16/HPV-pos)Experimental Treatment2 Interventions

Participants with p16/HPV-positive R/M HNSCC will be assigned to Cohort B. Participants will be administered lead-in low dose gemcitabine (LDG) 10 mg/m2 IV Day -7 (+/- 3 days, before Cycle 1 only) followed by ACR-368 105 mg/m2 IV every 2 weeks and LDG 10 mg/m2 every 2 weeks until discontinuation due to disease progression, intolerability, or consent withdrawal. When delay or discontinuation of the treatment is necessary, both ACR-368 and LDG will be delayed or discontinued together.

Group II: Cohort A (p16/HPV-neg)Experimental Treatment2 Interventions

Participants with p16/HPV-negative recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) will be assigned to Cohort A. Participants will be administered lead-in low dose gemcitabine (LDG) 10 mg/m2 IV Day -7 (+/- 3 days, before Cycle 1 only) followed by ACR-368 105 mg/m2 IV every 2 weeks and LDG 10 mg/m2 every 2 weeks until discontinuation due to disease progression, intolerability, or consent withdrawal. When delay or discontinuation of the treatment is necessary, both ACR-368 and LDG will be delayed or discontinued together.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

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