JPRN-jRCT2080223438已完成1 期
A phase I/II, multicenter, open-label study of MAK683 in adult patients with advanced malignancies
ovartis Pharma K.K.0 个研究点目标入组 14 人开始时间: 2017年1月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- •2. Patients with relapsed or refractory NHL with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014).
- •3. Patients with advanced or recurrent/metastatic malignancies, including
- •nasopharyngeal carcinoma (with presence of p16/CDKN2A gene), castration-resistant prostate cancer, gastric cancer, OCCC and sarcoma, with measurable lesion as determined by RECIST 1.1.
排除标准
- •1. Other malignant diseases than the ones being treated in this study
- •2. Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result.
- •3. B-cell lymphoma patients who have received prior allogeneic stem cell transplant
- •4. Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
- •5. Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control.
- •6. Unable to stop any prohibited medications, including strong cytochrome P450 (CYP) 3A4 inhibitors or inducers, long acting proton pump inhibitors and drugs with known risk of causing Torsades de pointes (TdP).
研究者
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