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Safety and efficacy of tipifarnib in head and neck cancer with HRAS mutations and impact of HRAS on response to therapy (AIM-HN/SEQ-HN) (KO-TIP-007)

Description

This is 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 study is the objective response rate.

Core eligibility

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

AIM-HN: Including patients who meet the following criteria:

  • 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 tumor progression or recurrence from at least one prior platinum-containing regimen in the primary, neoadjuvant, adjuvant, advanced, recurrent or metastatic setting
  • Known tumor missense HRAS mutation
  • Measurable disease by RECIST v1.1
  • ECOG performance status of 0-1
  • Acceptable liver, renal and hematological function

AIM-NH: Excluding patients who meet the following 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 four 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

SEQ-HN: Including patients who meet the following criteria:

  • 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)

SEQ-HN: Excluding patients who meet the following criteria:

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

Accepting new patients

 

Learn more at

clinicaltrials.gov