Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

  • End date
    Sep 21, 2024
  • participants needed
  • sponsor
    Kura Oncology, Inc.
Updated on 21 July 2022


This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.

Condition HNSCC
Treatment Tipifarnib, Alpelisib
Clinical Study IdentifierNCT04997902
SponsorKura Oncology, Inc.
Last Modified on21 July 2022


Yes No Not Sure

Inclusion Criteria

At least 18 years of age
Histologically confirmed head and neck cancer of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
Documented treatment failure from at least 1 prior systemic therapy in the R/M setting, unless determined not appropriate
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Has a tumor that is dependent upon HRAS and/or PIK3CA
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Acceptable liver, renal, endocrine, and hematologic function
Must be able to swallow alpelisib whole tablet or oral suspension containing crushed tablets. Feeding tube may not be used for alpelisib administration
Other protocol defined inclusion criteria may apply

Exclusion Criteria

Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (eg, mucosal melanoma)
Ongoing treatment with certain anticancer agents
Prior treatment (at least 1 full treatment cycle) with an FTI or PI3K, mTOR, or AKT inhibitor
Received treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months
Non-tolerable Grade 2, or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery
Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
Participant with an established diagnosis of diabetes mellitus Type 1 or not controlled Type 2
Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs based on Investigator discretion
Participant has currently documented pneumonitis/interstitial lung disease
Participant has a history of severe cutaneous reaction, such as Stevens-Johnson Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Other protocol defined exclusion criteria may apply
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