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A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) With HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC
Kura Oncology, Inc.
The first study cohort, named AIM-HN, will include patients with HRAS mutated Head and Neck Squamous Cell Carcinoma (HNSCC) HRAS. Patients enrolled in AIM-HN, will receive treatment with tipifarnib, Dose Level 1 orally, on days 1-7 and 15-21 of 28-day treatment cycles.
The second study cohort, SEQ-HN, is an observational sub-study and includes 2 types of patients: (1) the historical record of first line therapy in AIM-HN (HRAS mutant HNSCC) subjects in whom first line outcome data are available and (2) matched control HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.