Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Pharmacodynamic Effects and Predictive Biomarkers of JAK/STAT Inhibition With Ruxolitinib in Operable Head and Neck Cancer: a Window Trial
This study will 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.
In this study, ruxolitinib will be administered for a short period of 2-3 weeks prior to planned surgical resection of HNSCC. The dose will be 20 mg twice daily, the FDA-approved dose in myelofibrosis. The brief treatment duration is within the expected window of time that elapses from initial patient evaluation by a surgeon to performance of surgery. In the phase 0 or window trial model, a paired specimen analysis permits ex vivo evaluation of target modulation and pharmacodynamic changes in downstream or parallel molecular pathways.32 This study design is optimal in order to assess the biochemical and immunomodulatory effects of ruxolitinib on HNSCC. Furthermore, predictive biomarkers can be developed as related to a clinical endpoint or a biochemical, pharmacodynamic endpoint. ;
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