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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: Active Phase 2 study of Head and Neck Squamous Cell Carcinoma and Oral Mucositis, sponsored by MitoImmune Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
severe OM (WHO criteria Grade 3 or higher) at a cumulative radiation dose of 60 Gy
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-06-21 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04651634 still lists
NCT04651634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (49% lower).
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 lists 16 locations in 9 states (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.
Learn More About Clinical Trials
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Where NCT04651634's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma 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.
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