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NCT03515538 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers

A Phase 2 study, sponsored by EpicentRx.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT03515538 is a Phase 2 study that has completed, run by EpicentRx. The registered enrollment target is 53 participants.

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The verdict

NCT03515538, a Phase 2 study, has completed, sponsored by EpicentRx.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

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 duration or length 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 in arms 1, 2 and 3 will also receive RRx-001 on different schedules.

Interventions

  • RADIATION Radiation Therapy
  • DRUG RRx-001
  • DRUG Cisplatin for injection

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2018-07-12
Est. Completion 2020-10-08
Phase Phase 2

Sponsor

EpicentRx

15 total trials

What the Registry Record Tells You About NCT03515538

The ClinicalTrials.gov registry entry for NCT03515538 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EpicentRx, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Radiation Therapy is the first listed.

NCT03515538 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03515538 about?

NCT03515538 is a clinical study titled "Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers". The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length 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 give...

What is the current status of trial NCT03515538?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2018-07-12. Estimated completion is 2020-10-08.

What interventions are being tested in trial NCT03515538?

The interventions under investigation include: Radiation Therapy (RADIATION), RRx-001 (DRUG), Cisplatin for injection (DRUG).

Who is sponsoring clinical trial NCT03515538?

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

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

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