JPRN-UMIN000023149已完成1 期
A Phase Ib/II Study of BBI608 in Combination with Pembrolizumab in Patients with Metastatic Colorectal Cancer - SCOOP study
ational Cancer Center Hospital East0 个研究点目标入组 95 人开始时间: 2016年9月13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
- 95
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients who received chemotherapy, molecular-targeted agents and/or palliative radiotherapy within 2 weeks before the start of the protocol treatment or have not recovered from toxicity caused by previous treatment 2. Patients who underwent general anesthesia, surgery requiring hospitalization and extensive radiotherapy within 4 weeks before the start of the protocol treatment or minor surgery such as implantation of a central venous access device within two weeks before the start of the protocol treatment 3. Patients with active central nervous system metastases or carcinomatous meningitis. 4. Pregnant or lactating women 5. Patients who are unable or not willing to take BBI608 capsules every day 6. Patients with gastrointestinal disease markedly interfering with the absorption of oral formulations as judged by the investigator 7. Patients with active autoimmune disease requiring systemic treatment within 2 years before the start of the protocol treatment. 8. Patients with a history or signs of interstitial lung disease or active non-infectious pneumonitis 9. Patients who underwent organ or bone marrow transplantation 10. Patients who received a live vaccine within 30 days before the start of the protocol treatment 11. Patients who participated in another clinical study within 4 weeks before the start of the protocol treatment and used or using an investigational drug or device 12. Patients who previously received immunotherapy with drugs targeting PD-1, PD-L1 and/or PD-L2 or BBI608 therapy, or took part in a clinical study of pembrolizumab or BBI608 13. Patients with uncontrollable complications 14. Patients with a history of other malignancies within 3 years before the start of the protocol treatment. 15. Patients with clinically significant ECG abnormalities 16. Patients with a history of HIV 17. Patients with active hepatitis B or C
研究者
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