Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations
NCT ID: NCT02383927
Last Updated: 2024-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2015-05-13
2020-12-14
Brief Summary
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Detailed Description
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Subjects will be enrolled into three nonrandomized cohorts:
* Cohort 1: Malignant thyroid tumors with HRAS mutations.
* Cohort 2: Squamous Cell Carcinoma Head and Neck Cancer with HRAS mutations.
* Cohort 3: Squamous Cell Carcinoma (SCC) with HRAS mutations other than HNSCC.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Thyroid Cancer
Tipifarnib
FTase inhibitor
Cohort 2
Squamous Head and Neck Cancer
Tipifarnib
FTase inhibitor
Interventions
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Tipifarnib
FTase inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kura Oncology, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Hospital Universitario Doce de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
MD Anderson Cancer Center Madrid
Madrid, , Spain
START, Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Complejo Hospitalario de Navarro
Navarro, , Spain
Hospital Universitario Virgen de la Rocio
Seville, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Royal Marsden
London, England, United Kingdom
University College Hospital
London, England, United Kingdom
Countries
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References
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Ho AL, Brana I, Haddad R, Bauman J, Bible K, Oosting S, Wong DJ, Ahn MJ, Boni V, Even C, Fayette J, Flor MJ, Harrington K, Kim SB, Licitra L, Nixon I, Saba NF, Hackenberg S, Specenier P, Worden F, Balsara B, Leoni M, Martell B, Scholz C, Gualberto A. Tipifarnib in Head and Neck Squamous Cell Carcinoma With HRAS Mutations. J Clin Oncol. 2021 Jun 10;39(17):1856-1864. doi: 10.1200/JCO.20.02903. Epub 2021 Mar 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KO-TIP-001
Identifier Type: -
Identifier Source: org_study_id
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