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NCT05245682 · ClinicalTrials.gov registry record · Early Phase 1
Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer
A Early Phase 1 study of Head and Neck Carcinoma of Unknown Primary and Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by Emory University.
- Active
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05245682: Active Early Phase 1 study of Head and Neck Carcinoma of Unknown Primary and Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by Emory University.
NCT05245682 is a Early Phase 1 study of Head and Neck Carcinoma of Unknown Primary and Locally Advanced Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Emory University. The registered enrollment target is 10 participants, below the 71-participant average among 6 other Head and Neck Carcinoma of Unknown Primary trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05245682, a Early Phase 1 study of Head and Neck Carcinoma of Unknown Primary and Locally Advanced Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This early-phase trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past (previously untreated), has spread to nearby tissue or lymph nodes (locally advanced) and cannot receive cisplatin (cisplatin-ineligible). Tolinapant may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving tolinapant and radiation therapy may kill more tumor cells.
Primary Outcome
Safety will be assessed on clinical examination and measurement of laboratory parameters. All safety assessments including adverse events, clinical laboratory evaluations, and vital signs will be summarized with descriptive statistics, where appropriate, and listed in the data listings using MedDRA terms.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Tolinapant
Study Locations (1)
Georgia
- Emory University/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-02-17 |
| Est. Completion | 2026-07-21 |
| Phase | Early Phase 1 |
What the registry record for NCT05245682 still lists
NCT05245682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 71-participant average among 6 other Head and Neck Carcinoma of Unknown Primary trials with a reported enrollment target (86% lower).
The record links to 6 conditions, with Head and Neck Carcinoma of Unknown Primary appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT05245682 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05245682 about?
NCT05245682 is a clinical study titled "Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer". This early-phase trial tests the safety and side effects of a tolinapant given together with radiation therapy in treating patients with head and neck cancer for which the patient has not received treatment in the past (previously untreated), has spread to nearby tissue or lymph nodes (locally advan...
What is the current status of trial NCT05245682?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2022-02-17. Estimated completion is 2026-07-21.
What conditions does trial NCT05245682 study?
This clinical trial studies the following conditions: Head and Neck Carcinoma of Unknown Primary, Locally Advanced Head and Neck Squamous Cell Carcinoma, Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Locally Advanced Laryngeal Squamous Cell Carcinoma, Locally Advanced Oropharyngeal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05245682?
The interventions under investigation include: Radiation Therapy (RADIATION), Tolinapant (DRUG).
Who is sponsoring clinical trial NCT05245682?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05245682 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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