Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04533750
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Head and Neck Squamous Cell Carcinoma
  • Advanced Hypopharyngeal Squamous Cell Carcinoma
  • Advanced Laryngeal Squamous Cell Carcinoma
  • Advanced Oral Cavity Squamous Cell Carcinoma
  • Advanced Oropharyngeal Squamous Cell Carcinoma
  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Stage III Hypopharyngeal Carcinoma AJCC v8
  • Stage III Laryngeal Cancer AJCC v8
  • Stage III Lip and Oral Cavity Cancer AJCC v8
  • Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVA Hypopharyngeal Carcinoma AJCC v8
  • Stage IVA Laryngeal Cancer AJCC v8
  • Stage IVA Lip and Oral Cavity Cancer AJCC v8
  • Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVB Hypopharyngeal Carcinoma AJCC v8
  • Stage IVB Laryngeal Cancer AJCC v8
  • Stage IVB Lip and Oral Cavity Cancer AJCC v8
  • Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Fludeoxyglucose F-18 — OTHER
    Given IV
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Peposertib — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

This phase I trial investigates the side effects and best dose of peposertib when given together with radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced) who cannot take cisplatin. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This trial aims to see whether adding peposertib to radiation therapy is safe and works well in treating patients with head and neck cancer.

Key Dates

Start date
Dec 20, 2021
Status verified
Dec 2025
Primary completion
Dec 7, 2025
Completion
Dec 15, 2026

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (peposertib, IMRT)
    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.

Primary Outcome Measure

Dose-limiting toxicity [ Time Frame: Up to 28 days after the end of intensity-modulated radiation therapy (IMRT) ]

Locations (27)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
Banner University Medical Center - TucsonTucsonArizona85719-
University of Arizona Cancer Center-North CampusTucsonArizona85719-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Stanford Cancer Institute Palo AltoPalo AltoCalifornia94304-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Carle at The RiverfrontDanvilleIllinois61832-
Carle Physician Group-EffinghamEffinghamIllinois62401-
Carle Physician Group-Mattoon/CharlestonMattoonIllinois61938-
Carle Cancer CenterUrbanaIllinois61801-
The James Graham Brown Cancer Center at University of LouisvilleLouisvilleKentucky40202-
NYU Langone Hospital - Long IslandMineolaNew York11501-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
Highland HospitalRochesterNew York14620-
University of RochesterRochesterNew York14642-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Providence Portland Medical CenterPortlandOregon97213-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Sanford Cancer Center Oncology ClinicSioux FallsSouth Dakota57104-
Sanford USD Medical Center - Sioux FallsSioux FallsSouth Dakota57117-5134-
M D Anderson Cancer CenterHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZMayo Clinic Hospital in Arizona· Phoenix, AZBanner University Medical Center - Tucson· Tucson, AZUniversity of Arizona Cancer Center-North Campus· Tucson, AZUC San Diego Moores Cancer Center· La Jolla, CAStanford Cancer Institute Palo Alto· Palo Alto, CA

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