Phase II Study of Tipifarnib in Advanced Cancers With HRAS Mutations

Description

Phase II study to investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available.

Study Start Date

March 2015

Estimated Completion Date

December 2017

Interventions

  • Drug: Tipifarnib

Specialties

  • Internal Medicine: Endocrinology,Hematology/Oncology
  • Nursing: Endocrinology,Hematology/Oncology
  • Endocrinology: Thyroid/Parathyroid
  • Oncology: Endocrine Oncology,Head and Neck
  • Physician Assistant: Endocrinology,Hematology/Oncology

MeSH Terms

  • Head and Neck Neoplasms
  • Neoplasms
  • Thyroid Neoplasms

Study ID

Kura Oncology, Inc. -- KO-TIP-001

Status

Unknown

Trial ID

NCT02383927

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

36

Sponsor

Kura Oncology, Inc.

Inclusion Criteria

  • histologically or cytologically confirmed diagnosis of non-hematological malignancy for which there is no curative therapy available.
  • tumor that carries a missense HRAS mutation
  • Subject consents to provide at least 10 unstained tumor slides for retrospective testing of HRAS gene tumor status
  • Subject has measurable disease according to RECIST v1.1 and has relapsed or is refractory to prior therapy.
  • At least 2 weeks since the last systemic therapy or radiotherapy regimen prior to enrolment
  • ECOG PS 0 or 1
  • Acceptable liver function
  • Acceptable renal function
  • Acceptable hematologic status

Exclusion Criteria

  • Prior treatment with an FTase inhibitor
  • History of relevant coronary heart disease or myocardial infarction within last 3 years, NYHA Grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or serious cardiac arrhythmia requiring medication except atrial fibrillation.
  • Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Day 1.
  • Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks first dose
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to first dose, without complete recovery.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles None None None
Memorial SloanKettering Cancer Center - New York, New York 187.1 miles None None None
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
Mayo Clinic - Rochester, Minnesota 1,083.2 miles None None None
The University of Texas MD Anderson Cancer Center - Houston, Texas 1,609.9 miles None None None
Mayo Clinic - Scottsdale, Arizona 2,280.6 miles None None None

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