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NCT05966194 · ClinicalTrials.gov registry record · Phase 2

RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

A Phase 2 study of Oral Mucositis, sponsored by EpicentRx.

Recruiting
Registry status
Phase 2
Development phase
216
Enrollment target
14
Study locations

NCT05966194 is a Phase 2 study of Oral Mucositis that is actively recruiting participants, run by EpicentRx. The registered enrollment target is 216 participants, above the 86-participant average among 10 other Oral Mucositis trials with a reported enrollment target (151% higher). The trial reports 14 study locations across 13 states.

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The verdict

NCT05966194, a Phase 2 study of Oral Mucositis, is actively recruiting participants, sponsored by EpicentRx.

RECRUITING
Registry status
Phase 2
Development phase
216 participants
Enrollment target
14
Study locations

Study Summary

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.

Conditions Studied

Interventions

  • RADIATION Intensity Modulated Radiation Therapy (IMRT)
  • DRUG RRx-001
  • DRUG Cisplatin for injection 100 mg/m2

Study Locations (14)

Arizona

  • Banner MD Anderson Cancer Center - Gilbert
  • The University of Arizona Cancer Center - Tucson

Florida

  • Miami Cancer Institute - Miami

Illinois

  • Northwestern University Feinberg School of Medicine - Chicago

Indiana

  • Parkview Cancer Institute - Fort Wayne

Louisiana

  • Willis Knighton Cancer Center - Shreveport

Maryland

  • Sandra and Malcolm Berman Cancer Institute - Baltimore

Michigan

  • University of Michigan - Ann Arbor

Nevada

  • Renown Regional Medical Center - Reno

Trial Details

FieldValue
Enrollment Target 216 participants
Start Date 2024-04-02
Est. Completion 2025-10-01
Phase Phase 2

Sponsor

EpicentRx

15 total trials

What the Registry Record Tells You About NCT05966194

The ClinicalTrials.gov registry entry for NCT05966194 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 86-participant average among 10 other Oral Mucositis trials with a reported enrollment target (151% higher). The listed sponsor is EpicentRx, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Oral Mucositis appearing as the primary indexed condition, and to 3 interventions - of which Intensity Modulated Radiation Therapy (IMRT) is the first listed.

NCT05966194 reports 14 study locations spanning 13 distinct geographic areas - top geographies include Arizona, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT05966194 about?

NCT05966194 is a clinical study titled "RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer". The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with th...

What is the current status of trial NCT05966194?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2024-04-02. Estimated completion is 2025-10-01.

What conditions does trial NCT05966194 study?

This clinical trial studies the following conditions: Oral Mucositis.

What interventions are being tested in trial NCT05966194?

The interventions under investigation include: Intensity Modulated Radiation Therapy (IMRT) (RADIATION), RRx-001 (DRUG), Cisplatin for injection 100 mg/m2 (DRUG).

Who is sponsoring clinical trial NCT05966194?

This trial is sponsored by EpicentRx, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05966194 being conducted?

This trial has 14 study locations across Arizona, Florida, Illinois, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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