NL-OMON47325已完成不适用
A phase I study of SGI-110 combined with irinotecan followed by a randomized phase II study of SGI-110 combined with irinotecan versus regorafenib or TAS-102 in previously treated metastatic colorectal cancer patients. - CORSICA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
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
- 18 至 99（—）
入选标准
- •Histologically or cytologicaly confirmed adenocarcinoma of the colon or rectum,
- •Patients in phase I must have biopsiable diasese and be amenable to having two research biopsies.
- •Patients must have progressed on irinotecan therapy in the metastic setting. There are no limitation on number of prior therapies. They should have a life expectancy of greater than 12 weeks, an
排除标准
- •Chemotherapy or radiotherapy within 4 weeks prior to entering the study,
- •Known brain metastases,
- •Uncontrolled intercurrent illness,
- •Prior therapy with any hypomethylating agent,
- •A history of a different malignancy unless disease-free for at least 5 years,
- •HIV positive individuals on HAART
- •Previoius treatement with regorafenb and TAS-102 (this applies to phase II only. If patients have previously received aeither regorafenib or tas-102, they must be able to receive the alternate regimen if randomized to the standard of care arm)
- •Hospitalization for an acute medical issue within 4 weeks prior to screening visit
- •Symptomatic bowel obstruction within 6 months prior to enrollment. Patients who undergo surgical correction of obstructing lesion will be eligible within 6 months.
研究者
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