![]() ![]() Lee Moffitt Cancer Center and Research Institute Whittier, California, United States, 90603 The Oncology Institute of Hope and Innovation - Anaheim San Francisco, California, United States, 94158 UCSF - Helen Diller Family Comprehensive Cancer Center Los Angeles, California, United States, 90095 UCLA - Jonsson Comprehensive Cancer Center Los Angeles, California, United States, 90033 University of Southern California Norris Comprehensive Cancer Center Other protocol defined exclusion criteria may apply Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. Other protocol defined inclusion criteria may applyġ.HRAS wildtype (i.e., have no identified tumor missense HRAS mutation).Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC.Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.Other protocol defined exclusion criteria may apply.Received treatment for non-cancer related liver disease within prior year.Known history of infection with human immunodeficiency virus or an active infection with hepatitis B or hepatitis C. Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy.Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.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.Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g.Other protocol defined inclusion criteria may apply.Acceptable liver, renal and hematological function.tumor progression, clinical deterioration, or recurrence), and from at least one prior platinum-containing regimen, in any treatment setting. Documented treatment failure from most recent prior therapy (e.g.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).Outcome data from subsequent lines of therapy will be collected. ![]() 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. HNSCC patients in whom HRAS mutations are not identified may participate in SEQ-HN only. HNSCC patients in whom HRAS mutations are identified and who meet eligibility criteria will be offered participation in AIM-HN. 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. 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 first study cohort, named AIM-HN, includes HNSCC subjects with HRAS mutations. 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). Why Should I Register and Submit Results?.
0 Comments
Leave a Reply. |