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The AIM-HN and SEQ-HN Study: 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 (SEQ-HN).
This is an international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. 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 subjects with HRAS mutant HNSCC participating in Cohort 1 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.
Primary Objective: To determine the ORR of tipifarnib in subjects with HNSCC with HRAS mutations as assessed by IRF. Secondary Objectives: To determine the anti-tumor activity of tipifarnib in terms of: time to response, DOR, TTP, PFS, one year progression free rate, one year survival and OS. To investigate the safety and tolerability of tipifarnib according to the NCI CTCAE v5.0. To assess population PK of tipifarnib in subjects with HNSCC with HRAS mutations. Exploratory Objectives: To identify HRAS mutations and assess their effect on the ORR of first line systemic therapy in patients with recurrent/metastatic HNSCC. To assess the treatment outcome to first line systemic therapy in terms of PFS, DOR, and OS in patients with recurrent/metastatic HNSCC with HRAS mutations. To describe demographic characteristics prevalent in patients with HNSCC with HRAS mutations. To explore the frequency and treatment outcome interaction of other HNSCC genetic alterations. To identify trends in the data that may suggest relationships between covariates of interest and treatment outcome in patients with HNSCC with HRAS mutations.