Spots Global Cancer Trial Database for Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations
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Trial Identification
Brief Title: Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations
Official Title: An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies With HRAS Mutations
Study ID: NCT02383927
Interventions
Study Description
Brief Summary: 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. Note; Only cohort 2 (Head \& Neck SCC) and cohort 3 (Other SCC) are currently open
Detailed Description: This Phase II study will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced, unresectable or metastatic, relapsed and/or refractory tumors that carry HRAS mutations and for whom there is no curative therapy available. Subjects with information available on tumor HRAS status previously generated are eligible. All subjects must consent to provide at least 10 tumor slides from a prior diagnostic biopsy for a retrospective testing of HRAS gene status at a central facility. Subjects will be enrolled into three nonrandomized cohorts: * Cohort 1: Malignant thyroid tumors with HRAS mutations (cohort is closed). * Cohort 2: Squamous Cell Carcinoma Head and Neck Cancer with HRAS mutations. * Cohort 3: Squamous Cell Carcinoma (SCC) with HRAS mutations other than HNSCC
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Attikí, , Greece
Instituto Nazionale Tumori, Milan, , Italy
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
University Medical Center, Groningen, , Netherlands
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, Sevilla, , Spain
Hospital Universitario y Politécnico La Fe, Valencia, , Spain
Royal Marsden, London, England, United Kingdom
University College Hospital, London, England, United Kingdom
Contact Details
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