JPRN-jRCT2080223127已完成2 期
A PHASE 2, OPEN LABEL, SINGLE-ARM STUDY TO ASSESS THE SAFETY AND EFFICACY OF TAS-116 IN PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMORS (GIST) AFTER DISEASE PROGRESSION ON, OR INTOLERANCE TO IMATINIB, SUNITINIB AND REGORAFENIB
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
研究概览
简要总结
This study suggests that TAS-116 provides a novel and effective treatment option for patients with advanced and treatment resistant GIST.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Key inclusion criteria
- •- Provided written informed consent
- •- Histologically confirmed GIST.
- •- Have had previous treatments of imatinib, sunitinb and regorafenib
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
排除标准
- •Key exclusion criteria
- •- A serious illness or medical condition
- •- Previous or concurrent cancer that is distinct in primary disease or histology from the cancer that is being evaluated in this study. (Cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia and any previous cancer curatively treated more than 5 years before the enrollment can be eligible.)
- •- Pregnant or lactating female (including the cessation of lactation) or females of child-bearing potential who have a positive pregnancy test proceeded during the Baseline Period.
研究者
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