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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)

Description

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 and includes 2 types of patients: (1) the historical record of first line therapy in subjects with HRAS mutant HNSCC participating in Cohort 1 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.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this trial is to determine the objective response rate in high variable allele frequency (VAF) population--complete response and partial response.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Accepting patients who meet the following criteria:

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.

Excluding patients who meet these criteria:

  • 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

Accepting patients who meet the following 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

Excluding patients who meet these criteria:

  • Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (e.g. mucosal melanoma).

Other protocol defined exclusion criteria may apply

     

Accepting new patients

 

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