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

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 Ruxolitinib
    Participants 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)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-
University of California, San FranciscoSan FranciscoCalifornia94143-

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