Phase II Study of Tipifarnib in Advanced Cancers With HRAS Mutations
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
Estimated Completion Date
- Drug: Tipifarnib
- Internal Medicine: Endocrinology,Hematology/Oncology
- Nursing: Endocrinology,Hematology/Oncology
- Endocrinology: Thyroid/Parathyroid
- Oncology: Endocrine Oncology,Head and Neck
- Physician Assistant: Endocrinology,Hematology/Oncology
- Head and Neck Neoplasms
- Thyroid Neoplasms
Kura Oncology, Inc. -- KO-TIP-001
Kura Oncology, Inc.
- 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
- 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
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (6)
|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|