NL-OMON47541已完成2 期
The REPEAT trial: Regorafenib in combination with Paclitaxel in advanced oesophagogastric carcinoma, a phase 1b study - REPEAT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
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 64（—）
入选标准
- •* Patient must understand, be willing to give consent, and sign a written
- •informed consent form prior to undergoing any study-specific procedure
- •* Male or female and * 18 years of age
- •* Metastastic or non-resectable adeno- or squamous-cell carcinoma of the
- •stomach or oesophagus who failed on first line cytotoxic treatment with a
- •fluoropyrimidine and platinum compound
- •* Tumor accessible for repeated biopsies (expansion cohort only)
- •* Measurable disease
- •* Life expectancy of at least 12 weeks
- •* Eastern Cooperative Oncology Group performance status of 0 or 1 (within14
- •days prior to the initiation of study treatment)
- •* Have adequate bone marrow, liver function, and renal function
排除标准
- •* Prior treatment with regorafenib
- •* Contra-indications for repeated biopsies
- •* Dementia or altered mental status that would prohibit the understanding and
- •giving of informed consent
- •* Have unresolved toxicity higher than National Cancer Institute-Common
- •Terminology for Adverse Events version 4.0 (NCI-CTCAE v 4.0) Grade 1 attributed
- •to any prior therapy/procedure, excluding alopecia.
- •* Have had a major surgical procedure, open biopsy, or significant traumatic
- •injury within 28 days prior to initiation of study treatment
- •* Have currently suspected brain metastases
研究者
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