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ATR Inhibitor

Peposertib + Radiation for Advanced Head and Neck Cancer

Phase 1

Recruiting

Led By Maura L Gillison

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Known HIV infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and CD4 T cell count >= 200

Age >= 70 with moderate to severe comorbidity, defined as having one or more of the specified conditions within 30 days prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months and 1 year

Awards & highlights

Study Summary

This trial is testing the safety and efficacy of peposertib as a treatment for head and neck cancer that has spread to other parts of the body.

Who is the study for?

This trial is for adults with advanced head and neck cancer who can't take cisplatin. Participants must be HIV-positive on effective treatment, able to swallow tablets, willing to use contraception, have certain types of oropharynx cancer stages, measurable disease per RECIST 1.1 criteria, specific blood cell counts within range, and no history of distant metastatic disease.Check my eligibility

What is being tested?

The trial tests the safety and optimal dose of peposertib combined with intensity-modulated radiation therapy in patients with advanced head and neck cancer. It aims to determine if this combination is more effective than radiation alone for those unable to receive cisplatin.See study design

What are the potential side effects?

Potential side effects include reactions related to blocking enzymes needed for cell growth (which may affect normal cells as well), typical risks associated with radiation such as skin irritation or damage at the treatment site, fatigue, nausea, and other symptoms depending on which organs are affected by the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am HIV positive, on treatment, with undetectable viral load and CD4 count >= 200.

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I am 70 or older with one or more serious health conditions.

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My cancer is in the early to mid stages and located in my mouth, throat, or voice box.

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I cannot take cisplatin due to health reasons.

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I have been mostly active and able to carry out all pre-disease activities without restriction in the last 30 days.

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I am 18 or older and cannot take cisplatin due to health reasons.

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I can swallow pills without any issues.

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My throat cancer is p16 positive and falls within specific stages.

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My cancer is confirmed in the mouth, throat, voice box, or below the voice box.

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My oropharynx cancer is p16 positive, confirmed by a specific test.

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I am 18 years old or older.

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I am under 70 and have two or more severe health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity

Secondary outcome measures

Clinical response rate

Incidence of acute toxicity

Incidence of late toxicity

+2 more

Other outcome measures

Pharmacokinetic (PK) parameter of M3814 (peposertib)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (peposertib, IMRT)Experimental Treatment6 Interventions

Beginning 60-90 minutes before each radiation treatment, patients receive peposertib PO QD and undergo IMRT daily Monday-Friday for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or 18F-FDG PET/CT during screening and follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peposertib

2021

Completed Phase 1

~20

Computed Tomography

2017

Completed Phase 2

~2720