EUCTR2015-004535-12-BE进行中（未招募）1 期
An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies with HRAS Mutations
KURA ONCOLOGY Inc.0 个研究点目标入组 62 人开始时间: 2017年4月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subject has a histologically or cytologically confirmed diagnosis of non-hematological malignancy for which there is no curative therapy available: there will be 3 cohorts enrolling patients with more specific localizations of tumors. At this stage, only cohorts 2 and 3 will be open: Subjects must have HNSCC with HRAS mutations in order to be enrolled in the second stage of Cohort 2. Cohort 3 will enroll subjects with SCCs with HRAS mutations other than HNSCC, independently of tissue origin. Subjects with mucosal HNSCC with skin involvement will be enrolled in cohort 2 whereas subjects with primary skin SCC in the head and neck will be enrolled in cohort 3.
- •- tumors that carry a missense HRAS mutation
- •- Subject has consented 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 regimen prior to enrolment.
- •- At least 2 weeks since last radiotherapy.
- •- ECOG performance status of 0 or 1
- •- Acceptable liver function
- •- Acceptable renal function
- •- Acceptable hematologic status
- •- Higly effective method of contraception
- •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 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Prior treatment with an FTase inhibitor
- •- Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or current 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 of Cycle 1 Day 1. 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 Cycle 1 Day 1, 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.
研究者
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已完成
2 期
An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies with HRAS Mutations.advanced cancercancer with a specific genetic mutation10014713NL-OMON48820Kura Oncology, Inc6