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NCT04533750 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
A Phase 1 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Advanced Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 20
- Study locations
NCT04533750: Active Phase 1 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Advanced Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT04533750 is a Phase 1 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Advanced Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 221-participant average among 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04533750, a Phase 1 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Advanced Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- OTHER Fludeoxyglucose F-18
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Peposertib
Study Locations (20)
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic Hospital in Arizona - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Illinois
- Carle at The Riverfront - Danville
- Carle Physician Group-Effingham - Effingham
- Carle Physician Group-Mattoon/Charleston - Mattoon
- Carle Cancer Center - Urbana
New York
- NYU Langone Hospital - Long Island - Mineola
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
- Highland Hospital - Rochester
- University of Rochester - Rochester
California
- UC San Diego Moores Cancer Center - La Jolla
- Stanford Cancer Institute Palo Alto - Palo Alto
Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
Kentucky
- The James Graham Brown Cancer Center at University of Louisville - Louisville
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2026-12-15 |
| Phase | Phase 1 |
What the registry record for NCT04533750 still lists
NCT04533750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 221-participant average among 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials with a reported enrollment target (90% lower).
The record links to 10 conditions, with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT04533750 names 20 study sites across 8 states, led by Arizona, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT04533750 about?
NCT04533750 is a clinical study titled "Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin". 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 bl...
What is the current status of trial NCT04533750?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2021-12-20. Estimated completion is 2026-12-15.
What conditions does trial NCT04533750 study?
This clinical trial studies the following conditions: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Advanced Head and Neck Squamous Cell Carcinoma, Stage III Laryngeal Cancer AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Hypopharyngeal Carcinoma AJCC v8.
What interventions are being tested in trial NCT04533750?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Fludeoxyglucose F-18 (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Peposertib (DRUG).
Who is sponsoring clinical trial NCT04533750?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04533750 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04533750's enrollment target sits among peer trials
21 10th of 12 higher than 3 of 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 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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