ISRCTN75585722已完成1 期
Phase I dose-escalation study of S 78454 (HDACi) p.o. in combination with FOLFOX in patients with locally advanced or metastatic digestive cancer
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 60 人开始时间: 2013年9月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1. Male or female patient aged > or equal to 18 years
- •2. Any histological confirmed measurable or evaluable metastatic colorectal cancer (mCRC) or locally advanced or metastatic gastric or pancreatic cancer with a true primary resistance to FOLFOX
- •3. Ability to swallow oral capsule(s)
- •4. Ability to receive FOLFOX regimen
- •5. Estimated life expectancy > 12 weeks
- •6. Eastern Cooperative Oncology Group (ECOG) performance status < or equal to 1
- •7. Body mass index (BMI) > or equal to 20
- •8. Adequate haematological, renal and hepatic functions
排除标准
- •1. Major surgery within previous 4 weeks
- •2. Chemotherapy (other than FOLFOX) within previous 3 weeks
- •3. Small molecules treatment (tyrosine kinase inhibitor) or antibodies within previous 1 week
- •4. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
- •5. Pregnant or breastfeeding women, women of childbearing potential or men without effective contraception
- •6. Prior exposure to any histone deacetylase inhibitors (HDACi)
- •7. Neuropathy > grade 1
- •8. Unresolved diarrhea > grade 1
- •9. Concomitant uncontrolled severe systemic disease
- •10. Patient with impaired cardiac function
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