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ACTIVE NOT RECRUITING Phase 1

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

NCT04533750 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 21 participants
Start Date 2021-12-20
Est. Completion 2026-12-15
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04533750

The ClinicalTrials.gov registry entry for NCT04533750 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04533750 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Arizona, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04533750?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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