A Phase IA/IB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 12
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Parts A, B and C)
研究概览
简要总结
A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are being evaluated. This phase I study is also planned to enroll patients with advanced solid tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of TAS-116 on the 5 days on/2 days off regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or females with an age ≥ 18 years (≥ 20 years in Japan)
- •Patients with histological- or cytological-confirmed, advanced unresectable breast, gastric, or non-small cell lung cancer, who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
- •a. Part C: Only the following subtype of tumors with the molecular/genetic alterations will be enrolled: HER2 positive MBC Advanced NSCLC, harboring EGFR mutations after progression on osimertinib Advanced NSCLC, harboring ALK translocations after treatment with alectinib or at least 2 ALK inhibitors
- •Has At least one measurable lesion as defined by RECIST criteria
- •Is able to take medications orally (e.g., no feeding tube).
- •Is able to agree to and sign informed consent and to comply with the protocol
- •Has adequate organ function
排除标准
- •Has a serious illness or medical condition(s)
- •Has received treatment with any prescribed treatments within specified time frames prior to study drug administration
- •Significant ophthalmologic abnormality,
- •Impaired cardiac function or clinically significant cardiac disease
研究组 & 干预措施
TAS-116
干预措施: TAS-116 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Parts A, B and C)
时间窗: Safety monitoring will begin at the informed consent obtained and continue up to 28 days after the last dose of TAS-116 or until new anti-tumor therapy, whichever is earlier.
Number of patients experiencing Dose Limiting Toxicity graded according to CTCAE Version 4.03, observed in the Cycle 1 in order to meet the objective of assessment of the MTD of TAS-116 (Part A)
时间窗: 21 days in Cycle 1
Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Part C)
时间窗: Up to 2 Years
次要结局
- Progression Free Survival (Part C)(Up to last participant completes at least 6 months)
- Maximum Plasma Concentration (Cmax) after administration of TAS-116 (Parts A and B)(21 days in Cycle 1)
- Area under the plasma drug concentration-time curve (AUC) after administration of TAS-116 (Parts A and B)(21 days in Cycle 1)
- Disease Control Rate using RECIST 1.1 (Parts A, B, and C)(Up to last participant completes at least 6 months)
- Duration of Response (Part C)(Up to last participant completes at least 6 months)
- Overall Survival(Up to last participant completes at least 6 months)