Ruxolitinib in Operable Head and Neck Cancer
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT03153982
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib — DRUGGiven orally
Study Details
The purpose of this study is to assess the safety and efficacy of ruxolitinib in patients with operable Head and neck squamous cell carcinoma (HNSCC) who are planned for definitive surgery.
Key Dates
- Start date
- Jun 8, 2018
- Status verified
- Aug 2024
- Primary completion
- Oct 18, 2023
- Completion
- Oct 18, 2023
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Neoadjuvant RuxolitinibParticipants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.
Primary Outcome Measure
Proportional Percent Change in Tumor Size by Group [ Time Frame: Up to 4 weeks ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | - |
| University of California, San Francisco | San Francisco | California | 94143 | - |
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