Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

Completed · Phase 2

Conditions studied: HRAS Gene Mutation, HNSCC

In brief

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 including 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.

Key facts

Study ID

NCT03719690

Run by

Kura Oncology, Inc.

People needed

296

Starts

2019-03-15

Expected to finish

2023-05-02

Last updated by the study team

2024-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AIM-HN
• At least 18 years of age.
• Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
• Documented treatment failure from most recent prior therapy (e.g. tumor progression, clinical deterioration, or recurrence), and from at least one prior platinum-containing regimen, in any treatment setting.
• Known tumor missense HRAS mutation.
• Measurable disease by RECIST v1.1.
• ECOG performance status of 0-1.
• Acceptable liver, renal and hematological function
• Other protocol defined inclusion criteria may apply.

You may not qualify if…

• Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
• Received treatment for unstable angina within prior year, myocardial infarction within the prior year, cerebro-vascular attack within the prior year, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
• Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
• Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy. Known history of infection with human immunodeficiency virus or an active infection with hepatitis B or hepatitis C.
• Received treatment for non-cancer related liver disease within prior year.
• Other protocol defined exclusion criteria may apply
• Inclusion Criteria: SEQ-HN
• At least 18 years of age.
• Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.
• Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC.
• HRAS wildtype (i.e., have no identified tumor missense HRAS mutation).
• Other protocol defined inclusion criteria may apply
• Exclusion Criteria: SEQ-HN
• Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
• Other protocol defined exclusion criteria may apply

Where it is running

• UCLA - Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• UCSF - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• The Oncology Institute of Hope and Innovation - Anaheim — Whittier, California, United States
• Miami Cancer Institute — Miami, Florida, United States
• University of South Florida H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University Of Kansas Medical Center — Westwood, Kansas, United States
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Marlene and Stewart Greenebaum Cancer Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Siteman Cancer Center - Washington University Medical Campus — St Louis, Missouri, United States
• New York University Langone Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center-Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• San Antonio Military Medical Center — Fort Sam Houston, Texas, United States
• University of Southern California Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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