Trial purpose
Cancer treatment
Tumor type
Head and Neck
Age
18+
Trial acronym
AIM-HN/SEQ-HN
Clinical summary
Summary
The first study cohort, named AIM-HN, will include patients with HRAS mutated Head and Neck Squamous Cell Carcinoma (HNSCC) HRAS. Patients enrolled in AIM-HN, will receive treatment with tipifarnib, Dose Level 1 orally, on days 1-7 and 15-21 of 28-day treatment cycles. The second study cohort, SEQ-HN, is an observational sub-study and includes 2 types of patients: (1) the historical record of first line therapy in AIM-HN (HRAS mutant HNSCC) subjects in whom first line outcome data are available and (2) matched control 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.
Conditions
This trial is treating people with Head and Neck Squamous Cell Carcinoma
Eligibility
Inclusion
AIM-HN
- At least 18 years of age.
- 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).
- 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.
- Known tumor missense HRAS mutation.
- Measurable disease by RECIST v1.1.
- ECOG performance status of 0-1.
- Acceptable liver, renal and hematological function
- Other protocol defined inclusion criteria may apply.
Inclusion Criteria: SEQ-HN
- At least 18 years of age.
- Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology.
- Will or has received at least one systemic anti-cancer therapy for recurrent or metastatic HNSCC.
- HRAS wildtype (i.e., have no identified tumor missense HRAS mutation).
- Other protocol defined inclusion criteria may apply
Exclusion
- Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).
- 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.
- Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
- 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.
- Received treatment for non-cancer related liver disease within prior year.
- Other protocol defined exclusion 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
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Kura Oncology, Inc.
Scientific 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
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