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Brief Title: Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
Official Title: A Phase 1/2 Open-label, Biomarker-defined Cohort Trial to Evaluate the Safety, Determine the Recommended Combination Dosing, and Assess Early Antitumor Activity of Tipifarnib and Alpelisib for the Treatment of Adult Participants Who Have HRAS-overexpressing and/or PIK3CA-mutated and/or - Amplified Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Study ID: NCT04997902
Brief Summary: This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Lake Nona DDU (Florida Cancer Specialists), Orlando, Florida, United States
University of Maryland School of Medicine (Marlene and Stewart Greenebaum Comprehensive Cancer Center), Baltimore, Maryland, United States
Johns Hopkins University School of Medicine (Sidney Kimmel Comprehensive Cancer Center), Baltimore, Maryland, United States
Dana-Farber Cancer Institute (Head and Neck Cancer Treatment Center), Boston, Massachusetts, United States
Washington University, School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center (Harold C. Simmons Comprehensive Cancer Center), Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States