A Study of Tipifarnib in Patients with Head and Neck Cancers with HRAS Mutations

Full Title

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).

Purpose

The purpose of this study is to assess the effectiveness of the investigational drug tipifarnib in patients with head and neck cancers that contain mutations in the HRAS gene and continue to grow despite platinum-containing drugs or cannot be treated with this standard therapy. In HRAS-mutant cancers, HRAS proteins are inappropriately activated to cause normal cells to grow uncontrollably and become cancer cells.

Tipifarnib works by blocking an important enzyme involved in activating the mutated HRAS protein. By blocking this enzyme, tipifarnib might switch off the HRAS-mutant protein and block the growth of cancer cells. Tipifarnib is taken orally (by mouth).

Researchers in this study will also study how the HRAS gene mutation affects the response to other treatments compared to patients without an HRAS mutation.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HRAS-mutant head and neck cancer that continues to grow despite platinum-containing therapy, or cannot be treated with platinum-containing therapy and cannot be cured with another standard therapy.
  • At least 2 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alan Ho at 646-888-4235.

Protocol

19-121

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators