Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations

Completed · Phase 2

Conditions studied: Thyroid Cancer, Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), HRAS Mutant Tumor, Other Squamous Cell Carcinoma (SCC) With HRAS Mutant Tumor

In brief

Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available.

Key facts

Study ID

NCT02383927

Run by

Kura Oncology, Inc.

People needed

63

Starts

2015-05-13

Expected to finish

2020-12-14

Last updated by the study team

2024-07-11

Who can join

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

You may qualify if…

• histologically or cytologically confirmed diagnosis of thyroid cancer (cohort 1) or Squamous Cell Carcinoma head and neck cancer (cohort 2) or Squamous Cell Carcinoma other than HNSCC (cohort 3) for which there is no curative therapy available.
• tumor that carries a missense HRAS mutation ith a variant allele frequency (VAF) > 20%.
• Subject consents to provide at least 10 unstained tumor slides for retrospective testing of HRAS gene tumor status
• Subject has measurable disease according to RECIST v1.1 and has relapsed or is refractory to prior therapy.
• At least 2 weeks since the last systemic therapy or radiotherapy regimen prior to enrolment
• ECOG PS 0 or 1
• Acceptable liver function
• Acceptable renal function
• Acceptable hematologic status • Serum albumin ≥ 3.5 g/dL. Subjects with tumors potentially highly sensitive to tipifarnib (HRAS mutant VAF ≥ 35%) may be enrolled despite a serum albumin < 3.5 g/dL.

You may not qualify if…

• Prior treatment with an FTase inhibitor
• History of relevant coronary heart disease or myocardial infarction within last 3 years, NYHA Grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or serious cardiac arrhythmia requiring medication except atrial fibrillation.
• Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Day 1.
• Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks first dose
• Major surgery, other than diagnostic surgery, within 4 weeks prior to first dose, without complete recovery.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Wihship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Oklahoma University Health Sciences Center — Oklahoma City, Oklahoma, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University Hospital Antwerp — Antwerp, Belgium
• Cliniques universitaires Saint-Luc — Brussels, Belgium
• CHU — Yvoir, Belgium
• Insitut Bergonie — Bordeaux, France
• Centre Léon Bérard — Lyon, France
• Centre Antoine Lacassagne — Nice, France
• Institute Gustave Roussy (IGR) — Paris, France
• University Hospital Wuerazburg — Würzburg, Germany
• Attikon University Hospital — Attiki, Greece
• Instituto Nazionale Tumori — Milan, Italy
• University Medical Center — Groningen, Netherlands
• Asan Medical Center — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Hospital Vall d' Hebron — Barcelona, Spain
• Hospital Clinic de Barcelona — Barcelona, Spain
• Hospital del Mar — Barcelona, Spain

Full record on ClinicalTrials.gov

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