Ruxolitinib in Operable Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03153982|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Drug: Ruxolitinib||Phase 2|
Patients will take ruxolitinib twice daily during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tablets (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.
Dose will be assigned based on participant platelet count at baseline:
- Patients with a platelet count of 200,000 or greater will take 20 mg twice daily (four 5mg tablets in the morning and four 5mg tablets in the evening);
- Patients with a platelet count between150,000 and 200,000 will take 15 mg twice daily (three 5 mg tablets in the morning and three 5 mg tablets in the evening).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 8, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Head and neck squamous cell carcinoma
Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window. 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).
15 mg or 20 mg (three or four 5 mg tablets) by mouth twice daily
Other Name: Jakafi
- Change in Tumor Size [ Time Frame: Over the duration of the study, which is estimated to be approximately 24 months. ]Measured as a proportional percent (range -100% to +100%) from baseline to day of final dose of ruxolitinib
- Safety- toxicity, surgical complications, and length of hospital stay [ Time Frame: Over the duration of the study, which is estimated to be approximately 24 months. ]Safety will be reported descriptively, including tabulation of toxicities according to NCI CTCAE v.4, surgical complications, and length of hospital stay.
- Ki-67 [ Time Frame: Over the duration of the study, which is estimated to be approximately 24 months. ]The Ki-67 proliferative index will be measured in baseline and post-treatment tumor tissue.
- Biomarkers [ Time Frame: Over the duration of the study, which is estimated to be approximately 24 months. ]Biomarkers of ruxolitinib response or resistance will be analyzed for correlations with change in tumor size and change in Ki-67. Biomarkers to be analyzed included baseline activation and/or modulation of additional JAK/STAT3 signaling pathway proteins, baseline Src homology 2 domain-containing protein tyrosine phosphatase 2 (SHP-2) overexpression, and Reverse-phase protein array (RPPA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153982
|Contact: William Ryan, MDemail@example.com|
|Contact: Carter Hultmanfirstname.lastname@example.org|
|United States, Arizona|
|University of Arizona Cancer Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: Clinical Trials Office 866-278-1554 UACC-C3@uacc.arizona.edu|
|Sub-Investigator: Julie Bauman, MD|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Carter Hultman, CCRC 415-502-4707 Carter.Hultman@ucsf.edu|
|Principal Investigator:||William Ryan, MD||University of California, San Francisco|