Spots Global Cancer Trial Database for Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
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Trial Identification
Brief Title: Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
Official Title: A 2 Cohort, Non-comparative, Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) With HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)
Study ID: NCT03719690
Study Description
Brief Summary: 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.
Detailed Description: KO-TIP-007 is an international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN) and the impact of HRAS mutations on response to first line systemic therapies for HNSCC (SEQ-HN). KO-TIP-007 has 2 study cohorts. The first study cohort, named AIM-HN, includes HNSCC subjects with HRAS mutations. AIM-HN subjects will receive treatment with tipifarnib and the outcome of this cohort will be evaluated for ORR by an independent review facility. 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. HNSCC patients in whom HRAS mutations are identified and who meet eligibility criteria will be offered participation in AIM-HN. HNSCC patients in whom HRAS mutations are not identified may participate in SEQ-HN only. These patients will be followed and the comparison of outcomes of HRAS mutant and HRAS wild type HNSCC will address the exploratory objective to determine the effect of HRAS mutation on the ORR of first line systemic therapy in patients with recurrent/metastatic HNSCC. Outcome data from subsequent lines of therapy will be collected.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, United States
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, Saint 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
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Texas Health San Antonio - Mays Cancer Center, San Antonio, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Peter MacCallum Cancer Centre, Melbourne, , Australia
Royal North Shore Hospital, Saint Leonards, , Australia
Allgemeines Krankenhaus der Stadt Wien, Wien, , Austria
Hanusch Krankenhaus Wiener Gebietskrankenkasse, Wien, , Austria
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne, Yvoir, Namur, Belgium
Ziekenhuis Netwerk Antwerpen Middelheim, Antwerpen, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Leuven, Leuven, , Belgium
Rigshospitalet, Copenhagen, , Denmark
Herlev Hospital, Herlev, , Denmark
Charité Universitätsmedizin Berlin, Berlin, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Universitätsmedizin Mannheim, Mannheim, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
University General Hospital of Athens Attikon, Chaidari, , Greece
University General Hospital of Larissa, Larissa, , Greece
Bioclinic - Thessaloniki, Thessaloniki, , Greece
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliera S. Croce e Carle Cuneo, Cuneo, , Italy
Ospedale Mater Salutis di Legnago, Legnago, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori - Milano, Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy
Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte, Siena, , Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Chonbuk National University Hospital, Jeonju, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Yonsei University Health System Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea - Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital, Suwon, , Korea, Republic of
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Institut Kanser Negara, Putrajaya, , Malaysia
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Maastricht University Medical Centre, Maastricht, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Haukeland Universitetssjukehus, Bergen, , Norway
Radiumhospitalet, Oslo, , Norway
Hospital del Mar - Parc de Salut Mar, Barcelona, , Spain
Hospital de la Santa Creu i de Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebrón, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
HM Centro Integral Oncológico Clara Campal, Madrid, , Spain
Hospital Costa Del Sol, Marbella, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Clínico Universitario de Santiago de Compostela, Santiago De Compostela, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Chang Gung Medical Foundation Keelung Chang Gung Memorial Hospital, Keelung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Taoyuan, , Taiwan
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, , Thailand
Songklanagarind Hospital, Hat Yai, , Thailand
Guy's and Saint Thomas' NHS Foundation Trust, London, England, United Kingdom
NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
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