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NCT02567422 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer
A Phase 1 study of Head and Neck Squamous Cell Carcinoma and Head and Neck Carcinoma of Unknown Primary, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 19
- Study locations
NCT02567422: Active Phase 1 study of Head and Neck Squamous Cell Carcinoma and Head and Neck Carcinoma of Unknown Primary, sponsored by National Cancer Institute (NCI).
NCT02567422 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Head and Neck Carcinoma of Unknown Primary that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 43 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (63% lower). The trial reports 19 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02567422, a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Head and Neck Carcinoma of Unknown Primary, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 19
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of berzosertib (M6620) when given together with cisplatin and radiation therapy in treating patients with head and neck squamous cell carcinoma that has spread from where it started to nearby tissue or lymph nodes (locally advanced). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving M6620 together with cisplatin and radiation therapy may work better in treating patients with locally advanced head and neck squamous cell carcinoma.
Primary Outcome
According to the Cancer Therapy Evaluation Program National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v. 5). The highest grade experienced by the participant will be reported.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- PROCEDURE Magnetic Resonance Imaging
- OTHER Laboratory Biomarker Analysis
- DRUG Berzosertib
Study Locations (19)
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
California
- City of Hope Comprehensive Cancer Center - Duarte
- University of California Davis Comprehensive Cancer Center - Sacramento
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Ohio
- Case Western Reserve University - Cleveland
- Ohio State University Comprehensive Cancer Center - Columbus
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2017-04-17 |
| Est. Completion | 2026-05-14 |
| Phase | Phase 1 |
What the registry record for NCT02567422 still lists
NCT02567422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 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 (63% lower).
The record links to 10 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT02567422 lists 19 locations in 13 states (Connecticut, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT02567422 about?
NCT02567422 is a clinical study titled "Testing the Addition of M6620 (VX-970, Berzosertib) to Usual Chemotherapy and Radiation for Head and Neck Cancer". This phase I trial studies the side effects and best dose of berzosertib (M6620) when given together with cisplatin and radiation therapy in treating patients with head and neck squamous cell carcinoma that has spread from where it started to nearby tissue or lymph nodes (locally advanced). M6620 ma...
What is the current status of trial NCT02567422?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2017-04-17. Estimated completion is 2026-05-14.
What conditions does trial NCT02567422 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Head and Neck Carcinoma of Unknown Primary, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7.
What interventions are being tested in trial NCT02567422?
The interventions under investigation include: Computed Tomography (PROCEDURE), Cisplatin (DRUG), Magnetic Resonance Imaging (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Berzosertib (DRUG).
Who is sponsoring clinical trial NCT02567422?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02567422 being conducted?
This trial has 19 study locations across California, Connecticut, Georgia, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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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