EUCTR2015-004535-12-ESActive, not recruitingPhase 1
An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies with HRAS Mutations
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Kura Oncology, Inc.
- Enrollment
- 63
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 (or equivalent tumor tissue blocks) 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
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 emerging or rapidly progressing neurological symptoms within 4 weeks first dose. Non-tolerable grade 2 toxicities are defined as those with moderate symptoms that the patient is not able to endure for the conduct of instrumental activities of daily life or that persists = 7 days
- •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
Investigators
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