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Ruxolitinib in Operable Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:
Pharmacodynamic Effects and Predictive Biomarkers of Janus Kinases (JAK)/Signal Transducer and Activator of Transcription (STAT) Inhibition With Ruxolitinib in Operable Head and Neck Cancer: a Window Trial

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To identify baseline and/or pharmacodynamic biomarkers of response to ruxolitinib, based upon association with quantitative change in tumor size following 14-21 days of neoadjuvant ruxolitinib in patients with operable HNSCC as determined by quantitative change in Tumor size. SECONDARY OBJECTIVES: I. To describe the tolerability of brief neoadjuvant exposure to ruxolitinib II. To assess the effect of ruxolitinib on the tumoral Ki-67 proliferation index III. To evaluate additional candidate biomarkers of ruxolitinib response or resistance in HNSCC patients as determined by quantitative change in Tumor size, including: - Baseline activation and/or modulation of additional JAK/STAT3 signaling pathway proteins - Baseline SHP-2 overexpression - Reverse-phase protein array (RPPA) will be conducted on paired pre- and post-treatment tissue as a source of unbiased biomarker discovery. OUTLINE: Participants will be assigned neoadjuvant ruxolitinib based on participant platelet counts at baseline. Participants with a platelet count of 200,000 or greater will take 20 mg twice daily and participants with a platelet count between 150,000 and 200,000 will take 15 mg twice daily. Participants may continue treatment for up to 4 weeks from the time of study entry to time of planned standard of care surgery for cancer. Participants will be followed up for 12-weeks post-operation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03153982
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 2
Start date June 8, 2018
Completion date October 18, 2023
View Details
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