A Phase I/II Study of Tipifarnib and Alpelisib in People with Head and Neck Cancer

Share
Print

Full Title

A Phase 1/2 Open-label, Biomarker-defined Cohort Trial to Evaluate the Safety, Determine the Recommended Combination Dosing, and Assess Early Antitumor Activity of Tipifarnib and Alpelisib for the Treatment of Adult Participants who have HRAS Overexpressing and/or PIK3CA-mutated and/or -amplified Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (the Kurrent Trial)

Purpose

The purpose of this study is to assess the safety and effectiveness of giving the drugs tipifarnib and alpelisib together in people with head and neck cancer that has come back or continued to grow despite treatment. Participants in this study will have cancer with alterations in the PIK3CA or HRAS genes.

Alpelisib blocks the PI3K protein and tipifarnib blocks the HRAS protein. These proteins can promote cancer cell growth and spread. By blocking them, tipifarnib and alpelisib may stop cancer cells from growing and dividing. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have recurrent or persistent squamous cell carcinoma of the head and neck that contains either a change or extra copies of the PIK3CA gene or makes more than the usual amount of the HRAS protein.
  • At least 2 weeks must pass since the completion of prior therapies and receipt of the study medications.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Alan Ho at 646-608-3774.

Protocol

21-512

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators