Study on Combining Tipifarnib and Alpelisib for Adults with Recurrent or Metastatic Head and Neck Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of head and neck squamous cell carcinoma that cannot be treated with surgery or radiation to cure it.
• Have previously tried at least one other treatment for the cancer that did not work, unless not suitable.
• Have measurable cancer according to specific medical criteria.
• Have a tumor that relies on HRAS and/or PIK3CA.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have acceptable liver, kidney, hormone, and blood function.
• Must be able to swallow the medication in tablet form or as a liquid made from crushed tablets. Cannot use a feeding tube for taking the medication.
• Other specific criteria may apply as defined by the study protocol.

Exclusion Criteria

• Have a confirmed diagnosis of certain other types of cancer, such as salivary gland or thyroid cancer.
• Currently receiving certain other cancer treatments.
• Have previously been treated with similar types of drugs (FTI, PI3K, mTOR, or AKT inhibitors).
• Have had a heart attack or stroke within the last 6 months.
• Have significant nerve problems or unstable neurological symptoms recently.
• Have had major surgery recently without full recovery.
• Have active, uncontrolled infections needing treatment.
• Have uncontrolled diabetes or Type 1 diabetes.
• Have digestive issues that could affect drug absorption.
• Have lung diseases like pneumonitis or interstitial lung disease.
• Have a history of severe skin reactions.
• Other specific criteria may apply as defined by the study protocol.