HNSCC Clinical Trial
— AIM-HN/SEQ-HNOfficial 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)
Verified date | November 2022 |
Source | Kura Oncology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 284 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: AIM-HN 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 8. Other protocol defined inclusion criteria may apply. Exclusion Criteria: 1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma). 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. 6. Other protocol defined exclusion criteria may apply Inclusion Criteria: SEQ-HN 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). 5. Other protocol defined inclusion criteria may apply Exclusion Criteria: SEQ-HN 1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma). 5. Other protocol defined exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
Australia | Peter MacCallum Cancer Centre | Melbourne | |
Australia | Royal North Shore Hospital | Saint Leonards | |
Austria | Allgemeines Krankenhaus der Stadt Wien | Wien | |
Austria | Hanusch Krankenhaus Wiener Gebietskrankenkasse | Wien | |
Belgium | Ziekenhuis Netwerk Antwerpen Middelheim | Antwerpen | |
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
Belgium | Universitair Ziekenhuis Leuven | Leuven | |
Belgium | Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne | Yvoir | Namur |
Denmark | Rigshospitalet | Copenhagen | |
Denmark | Herlev Hospital | Herlev | |
Germany | Charité Universitätsmedizin Berlin | Berlin | |
Germany | Universitätsklinikum Leipzig | Leipzig | |
Germany | Universitätsmedizin Mannheim | Mannheim | |
Germany | Universitätsklinikum Würzburg | Würzburg | |
Greece | University General Hospital of Athens Attikon | Chaidari | |
Greece | University General Hospital of Larissa | Larissa | |
Greece | Bioclinic - Thessaloniki | Thessaloniki | |
Italy | 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 | |
Korea, Republic of | National Cancer Center | Goyang-si | |
Korea, Republic of | Chonbuk National University Hospital | Jeonju | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Korea University Anam Hospital | 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 | Yonsei University Health System Severance Hospital | Seoul | |
Korea, Republic of | The Catholic University of Korea St. Vincent's Hospital | Suwon | |
Malaysia | University Malaya Medical Centre | Kuala Lumpur | |
Malaysia | Institut Kanser Negara | Putrajaya | |
Netherlands | Universitair Medisch Centrum Groningen | Groningen | |
Netherlands | Maastricht University Medical Centre | Maastricht | |
Netherlands | Universitair Medisch Centrum Utrecht | Utrecht | |
Norway | Haukeland Universitetssjukehus | Bergen | |
Norway | Radiumhospitalet | Oslo | |
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu i de Sant Pau | Barcelona | |
Spain | Hospital del Mar - Parc de Salut Mar | Barcelona | |
Spain | Hospital Duran i Reynals | Barcelona | |
Spain | Hospital Universitari Vall d'Hebrón | Barcelona | |
Spain | HM Centro Integral Oncológico Clara Campal | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Virgen de la Victoria | Málaga | |
Spain | Hospital Costa Del Sol | Marbella | |
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 | |
Taiwan | 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 | |
Thailand | King Chulalongkorn Memorial Hospital | Bangkok | |
Thailand | Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | |
Thailand | Songklanagarind Hospital | Hat Yai | |
United Kingdom | NHS Greater Glasgow and Clyde | Glasgow | |
United Kingdom | Guy's and Saint Thomas' NHS Foundation Trust | London | England |
United Kingdom | The Royal Marsden NHS Foundation Trust | London | |
United Kingdom | University College London Hospitals NHS Foundation Trust | London | |
United Kingdom | The Christie NHS Foundation Trust | Manchester | |
United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | |
United States | Winship Cancer Institute | Atlanta | Georgia |
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 | Levine Cancer Institute | Charlotte | North Carolina |
United States | University of Chicago | Chicago | Illinois |
United States | The Ohio State University | Columbus | Ohio |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
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 Kentucky Markey Cancer Center | Lexington | Kentucky |
United States | UCLA - Jonsson Comprehensive Cancer Center | Los Angeles | California |
United States | University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | University of Wisconsin | Madison | Wisconsin |
United States | Miami Cancer Institute | Miami | Florida |
United States | Vanderbilt University Medical Center-Vanderbilt Ingram Cancer Center | Nashville | Tennessee |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | New York University Langone Medical Center | New York | New York |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Siteman Cancer Center - Washington University Medical Campus | Saint Louis | Missouri |
United States | University of Texas Health San Antonio - Mays Cancer Center | San Antonio | Texas |
United States | UCSF - Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | University of South Florida H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
United States | University Of Kansas Medical Center | Westwood | Kansas |
United States | The Oncology Institute of Hope and Innovation - Anaheim | Whittier | California |
Lead Sponsor | Collaborator |
---|---|
Kura Oncology, Inc. |
United States, Australia, Austria, Belgium, Denmark, Germany, Greece, Italy, Korea, Republic of, Malaysia, Netherlands, Norway, Spain, Taiwan, Thailand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate in High Variable Allele Frequency (VAF) population | complete response and partial response | 2 years | |
Secondary | Objective Response Rate in any VAF population | Determine anti-tumor activity of tipifarnib | 2 years | |
Secondary | Duration of Response in High VAF population | Determine anti-tumor activity of tipifarnib | 2 years | |
Secondary | Duration of Response in any VAF population | Determine anti-tumor activity of tipifarnib | 2 years | |
Secondary | Progression Free Survival in both high VAF and all VAF populations | Determine anti-tumor activity of tipifarnib | 6 and 9 months | |
Secondary | Overall survival in both high VAF and all VAF populations | Determine anti-tumor activity of tipifarnib | 1 year | |
Secondary | Overall survival in both high VAF and all VAF populations | Determine anti-tumor activity of tipifarnib | 2 years | |
Secondary | Investigate safety and tolerability of tipifarnib according to NCI CTCAE v5.0 | Incidence of adverse events, incidence of abnormal laboratory test results, abnormal vital signs, and abnormal ECG results | 30 days after treatment discontinuation | |
Secondary | Time to Response in both high VAF and all VAF populations | Determine anti-tumor activity of tipifarnib | 2 years | |
Secondary | Time to Progression in both high VAF and all VAF populations | Determine anti-tumor activity of tipifarnib | 2 years | |
Secondary | Investigate effects of tipifarnib treatment on quality of life using EORTC QLQ-H&N35 | Measured by changes of quality of life using the EORTC QLQ-H&N35 | 2 years | |
Secondary | Evaluate the concentration of tipifarnib [pharmacokinetics (PK)] in blood samples over time | Measured by blood samples collected during the first 6 cycles of treatment | 6 months | |
Secondary | Investigate effects of tipifarnib treatment on quality of life using EQ-5D-5L | Measured by changes of quality of life using the EQ-5D-5L. | 2 years |
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