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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

About

Brief Summary

The purpose of the observational part of the study (SEQ-HN) is to assess the effect of HRAS mutations on how well patients respond to their first treatment for their head and neck cancer that has returned or spread. Patients without an HRAS mutation will be enrolled in SEQ-HN to compare how well they respond to treatment for their head and neck cancer to patients who have an HRAS mutation. The purpose of the treatment portion of the study is to see how effective the study drug is to treat a patient's tumor. Other reasons for conducting the study are: • To determine for how long the study drug may reduce the size or slow down the growth of a patient's tumor. • To determine the side effects of the study drug. • To study a patient's tumor and determine why it responds or not to treatment with this study drug. Patients will take the study drug tablets daily, twice a day, alternating weeks on days 1-7 and on days 15-21 every 28 days. The week of treatment “holiday” between dosing weeks is done so that their body can recover from any side effects of the study drug. This treatment period of dosing on days 1-7 and days 15-21 followed by 7 days of rest is called a “cycle”. Each cycle is 28 days long. Patients will take the number of tablets assigned by their doctor every morning with a meal and approximately 12 hours later in the evening with another meal. The tablets should be swallowed whole with a large glass of water but may be chewed or crushed as instructed by their doctor. About 20 people will take part in this study at UCLA. Up to 59 people are expected to participate in this study worldwide. Patients will be followed for safety (labs, exams) monthly, and scans will occur every 8 weeks.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Adult patients diagnosed with Head and Neck Squamous Cell Cancer (HNSCC). For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Inclusion 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.

Exclusion 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

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 Criteria: SEQ-HN

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

5. Other protocol defined exclusion criteria may apply

Join this Trial

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Study Stats
Protocol No.
18-001687
Category
Hematology-Oncology
Oncology
Contact
Elizabeth Seja
Location
  • UCLA Beverly Hills
  • UCLA Burbank
  • UCLA Encino
  • UCLA Pasadena
  • UCLA Torrance
  • UCLA Valencia
  • UCLA Westwood
For Providers
NCT No.
NCT03719690
For detailed technical eligibility, visit ClinicalTrials.gov.