Phase II Trial of Dasatinib in Subjects With Advanced Cancers Harboring DDR2 Mutation or Inactivating B-RAF Mutation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating B-RAF mutation will respond to dasatinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)
Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
干预措施: Dasatinib (Drug)
Dasatinib, 140 mg (NSCLC With DDR2 Mutation)
Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
干预措施: Dasatinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From enrollment of last patient to 24 months or until all patients have died, whichever occurs first
ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter \[LD\] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.
次要结局
- Duration of Response (DOR)(From enrollment of last patient to 24 months or until all patients have died, whichever occurs first)
- Overall Survival(From enrollment of last patient to 24 months or until all patients have died, whichever occurs first)
- Progression-free Survival (PFS) Distribution(From Day 1 of study treatment to Week 12)
- Progression-free Survival (PFS)(From Day 1 of study treatment to Week 12)
- Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality(From enrollment of last patient to 24 months or until all patients have died, whichever occurs first)
- Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation(From enrollment of last patient to 24 months or until all patients have died, whichever occurs first)