Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamo… (NCT04997902) | Clinical Trial Compass
CompletedPhase 1/2
Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
United States45 participantsStarted 2021-12-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age.
✓. Histologically confirmed head and neck cancer of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
✓. Documented treatment failure from at least 1 prior systemic therapy in the R/M setting, unless determined not appropriate.
✓. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
✓. Has a tumor that is dependent upon HRAS and/or PIK3CA.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓. Acceptable liver, renal, endocrine, and hematologic function.
✓. Must be able to swallow alpelisib whole tablet or oral suspension containing crushed tablets. Feeding tube may not be used for alpelisib administration.
✕. Ongoing treatment with certain anticancer agents.
✕. Prior treatment (at least 1 full treatment cycle) with an FTI or PI3K, mTOR, or AKT inhibitor.
✕. Received treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months.
What they're measuring
1
Dose-limiting toxicity (DLT)
Timeframe: First 28 days (1 cycle) of combination therapy
2
Descriptive statistics of Adverse Events (AEs)
Timeframe: From Cycle 1 Day 1 until 30 days after last trial intervention dose or 30 days after trial completion, whichever comes first, assessed up to 2 years