An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination
研究概览
简要总结
The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.
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
- •The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
- •Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
- •The subject has a radiographically measurable tumor.
- •The subject is able to carry out daily life activities without difficulty.
- •The subject is able to swallow and retain oral medication.
- •The subject does not have significant side effects from previous anti-cancer treatment.
- •The subject has adequate organ and blood cell counts.
- •Sexually active subjects must use medically acceptable methods of contraception during the course of the study.
排除标准
- •The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
- •The subject has a brain tumor.
- •Current severe, uncontrolled systemic disease.
- •History of clinically significant heart, lung, or eye/vision problems.
- •The subject has high blood pressure that is not well-controlled with medication.
- •The subject has a permanent pacemaker.
- •The subject is pregnant or breastfeeding.
- •Positive for Hepatitis B, Hepatitis C, or HIV.
研究组 & 干预措施
Treatment Group 1
Trametinib plus Docetaxel
干预措施: Trametinib (GSK1120212) (Drug)
Treatment Group 1
Trametinib plus Docetaxel
干预措施: Docetaxel (Drug)
Treatment Group 2
Trametinib plus Erlotinib
干预措施: Trametinib (GSK1120212) (Drug)
Treatment Group 2
Trametinib plus Erlotinib
干预措施: Erlotinib (Drug)
Treatment Group 3
Trametinib plus Pemetrexed
干预措施: Trametinib (GSK1120212) (Drug)
Treatment Group 3
Trametinib plus Pemetrexed
干预措施: Pemetrexed (Drug)
Treatment Group 4
Trametinib plus Pemetrexed and Carboplatin
干预措施: Trametinib (GSK1120212) (Drug)
Treatment Group 4
Trametinib plus Pemetrexed and Carboplatin
干预措施: Pemetrexed (Drug)
Treatment Group 4
Trametinib plus Pemetrexed and Carboplatin
干预措施: Carboplatin (Drug)
Treatment Group 5
Trametinib plus nab-Paclitaxel
干预措施: Trametinib (GSK1120212) (Drug)
Treatment Group 5
Trametinib plus nab-Paclitaxel
干预措施: nab-Paclitaxel (Drug)
Treatment Group 6
Trametinib plus Pemetrexed and Cisplatin
干预措施: Trametinib (GSK1120212) (Drug)
Treatment Group 6
Trametinib plus Pemetrexed and Cisplatin
干预措施: Pemetrexed (Drug)
Treatment Group 6
Trametinib plus Pemetrexed and Cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination
时间窗: Duration of study (approximately 3 years)
次要结局
- To evaluate the anti-tumor activity as assessed by tumor response rate according to RECIST v1.1(Duration of study (approximately 3 years))
- To characterize population pharmacokinetic parameters(Duration of study (approximately 3 years))