An Open-Label, Phase Ib Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel in Japanese Subjects With Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Change from baseline in laboratory parameter values.
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and tolerability of the combination therapy of trametinib and docetaxel with growth factor support in Japanese subjects with Stage IV or a postoperative recurrence non-small cell lung cancer (NSCLC). This study data will be used for making decision for further Japanese development plan for NSCLC. Six evaluable subjects will be enrolled in a dose level to evaluate the safety and tolerability of the combination treatment. Dose-limiting toxicity will be assessed during the first 21 days of combination therapy.
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
- 20 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
Trametinib + Docetaxel + Filgrastim
Participants will receive Trametinib once daily for 21 days of each cycle + Intravenous Docetaxel once every three weeks over at least a one-hour infusion + Filgrastim (growth factor) subcutaneous injection once daily for prophylactic use.
干预措施: Trametinib (Drug)
Trametinib + Docetaxel + Filgrastim
Participants will receive Trametinib once daily for 21 days of each cycle + Intravenous Docetaxel once every three weeks over at least a one-hour infusion + Filgrastim (growth factor) subcutaneous injection once daily for prophylactic use.
干预措施: Docetaxel (Drug)
Trametinib + Docetaxel + Filgrastim
Participants will receive Trametinib once daily for 21 days of each cycle + Intravenous Docetaxel once every three weeks over at least a one-hour infusion + Filgrastim (growth factor) subcutaneous injection once daily for prophylactic use.
干预措施: Filgrastim (Drug)
结局指标
主要结局
Change from baseline in laboratory parameter values.
时间窗: Baseline and up to 6 months
Laboratory parameters include: hematology, clinical chemistry, coagulation tests and urinalysis tests.
Change from baseline in vital sign values
时间窗: Baseline and up to 6 months
Vital sing measurement include: temperature, systolic blood pressure, diastolic blood pressure, heart rate, and blood oxygen saturation (SpO2)
Number of participants with Adverse events (AEs).
时间窗: Baseline and up to 6 months
AEs will be collected from the time the first dose of study treatment is administered until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice
次要结局
- Composite of pharmacokinetic (PK) parameters for(PK samples will be collected at pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 24 hours (pre-dose) post-dose/infusion start)
- Composite of PK parameters for Docetaxel(PK samples will be collected at pre-dose, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 24 hours (pre-dose) post-dose/infusion start)
- Tumor response as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1(6 months)