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Spots Global Cancer Trial Database for Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

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Trial Identification

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

Conditions

HNSCC

Interventions

Tipifarnib
Alpelisib

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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