Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy
NCT ID: NCT03719690
Last Updated: 2024-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
296 participants
INTERVENTIONAL
2019-03-15
2023-05-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AIM-HN
Tipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles
Tipifarnib
Tablet for oral administration
HRAS Detection Assay
In Vitro Assay to detect HRAS mutations
SEQ-HN
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.
No interventions assigned to this group
Interventions
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Tipifarnib
Tablet for oral administration
HRAS Detection Assay
In Vitro Assay to detect HRAS mutations
Eligibility Criteria
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Inclusion Criteria
1. At least 18 years of age.
2. 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).
3. 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.
4. Known tumor missense HRAS mutation.
5. Measurable disease by RECIST v1.1.
6. ECOG performance status of 0-1.
7. Acceptable liver, renal and hematological function
1. At least 18 years of age.
2. Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.
3. Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC.
4. HRAS wildtype (i.e., have no identified tumor missense HRAS mutation).
Exclusion Criteria
2. 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.
3. Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
4. 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.
5. Received treatment for non-cancer related liver disease within prior year.
1\. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
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 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
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
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
Vienna, , Austria
Hanusch Krankenhaus Wiener Gebietskrankenkasse
Vienna, , Austria
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
Yvoir, Namur, Belgium
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, , 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
Chaïdári, , 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
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, , Italy
Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte
Siena, , Italy
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
National Cancer Center
Goyang-si, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Yonsei University Health System Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, , South Korea
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
Seville, , 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 City, , 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 City, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KO-TIP-007
Identifier Type: -
Identifier Source: org_study_id
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