An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 145
- 主要终点
- Maximum tolerated dose (Part 1)
研究概览
简要总结
This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •adult patients, >=18 years of age;
- •advanced and/or metastatic cancer not amenable to standard therapy;
- •any solid tumor type (Part 1); malignant melanoma or other responsive tumor type (Part 2);
- •measurable and/or evaluable disease (Part 1); >=1 measurable lesion (Part 2);
- •ECOG performance status 0-2.
排除标准
- •prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
- •prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
- •active CNS lesions;
- •acute or chronic infection.
研究组 & 干预措施
1
干预措施: RO4987655 (Drug)
2
干预措施: RO4987655 (Drug)
结局指标
主要结局
Maximum tolerated dose (Part 1)
时间窗: Reviewed after each 4 week cycle
Tumor assessments (Part 2)
时间窗: Every 8 weeks
次要结局
- Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2)(Reviewed after each 4 week cycle)