Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
Summary
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.