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NCT04651634 · ClinicalTrials.gov registry record · Phase 2

MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients

A Phase 2 study of Head and Neck Squamous Cell Carcinoma and Oral Mucositis, sponsored by MitoImmune Therapeutics.

Active
Registry status
Phase 2
Development phase
60
Enrollment target
16
Study locations

NCT04651634 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Oral Mucositis that is active but no longer recruiting, run by MitoImmune Therapeutics. The registered enrollment target is 60 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (49% lower). The trial reports 16 study locations across 9 states.

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The verdict

NCT04651634, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Oral Mucositis, is active but no longer recruiting, sponsored by MitoImmune Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
16
Study locations

Study Summary

The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are undergoing concurrent chemoradiotherapy (CCRT).

Conditions Studied

Head and Neck Squamous Cell Carcinoma Oral Mucositis

Interventions

  • DRUG MIT-001 plus CCRT

Study Locations (16)

Other

  • Keimyung University Dongsan Hospital - Daegu
  • Chungnam National University Hospital - Daejeon
  • National Cancer Center - Goyang-si
  • Seoul National University Bundang Hospital - Gyeonggi-do
  • Inha University Hospital - Incheon
  • Seoul National University Hospital - Seoul
  • Korea University Guro Hospital - Seoul
  • Hanyang University Seoul Hospital - Seoul

Arizona

  • Banner MD Anderson Cancer Center - Gilbert

California

  • Norris Comprehensive Cancer Center - Los Angeles

Kansas

  • Cancer Center of Kansas - Wichita

New York

  • James P. Wilmot Cancer Center - Rochester

North Carolina

  • Wake Forest Baptist Health - Comprehensive Cancer Center - Winston-Salem

Ohio

  • James Cancer Hospital Solove Research Institute - Columbus

Gyeonggi-do

  • The Catholic University of Korea Saint Vincent's Hospital - Suwon

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-06-21
Est. Completion 2025-12-31
Phase Phase 2

Sponsor

MitoImmune Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04651634

The ClinicalTrials.gov registry entry for NCT04651634 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (49% lower). The listed sponsor is MitoImmune Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which MIT-001 plus CCRT is the first listed.

NCT04651634 reports 16 study locations spanning 9 distinct geographic areas - top geographies include Other, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT04651634 about?

NCT04651634 is a clinical study titled "MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients". The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo in prevention of oral mucositis (OM) in patients with HNSCC who are unde...

What is the current status of trial NCT04651634?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-06-21. Estimated completion is 2025-12-31.

What conditions does trial NCT04651634 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Oral Mucositis.

What interventions are being tested in trial NCT04651634?

The interventions under investigation include: MIT-001 plus CCRT (DRUG).

Who is sponsoring clinical trial NCT04651634?

This trial is sponsored by MitoImmune Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04651634 being conducted?

This trial has 16 study locations across Arizona, California, Kansas, New York, North Carolina. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.