A Phase 1/1b, Open-label Study in Patients With Recurrent Glioblastoma to Assess the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide
研究概览
简要总结
This is an open-label, single arm, Phase 1 study to assess the safety and tolerability of macitentan in combination with dose-dense temozolomide in adult patients with recurrent glioblastoma or gliosarcoma. The study is composed of three parts. A Phase 1 Dose Escalation Period with a traditional 3+3 design will determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide. A Phase 1b Period will expand the safety and tolerability data of two doses of macitentan and dose-dense temozolomide selected from the Dose Escalation Period and explore efficacy. An Ancillary Study will further evaluate the effects of macitentan on biomarkers in brain tumor tissue.
The study is planned to have a minimum duration of 12 months. The study will end when all patients (excluding those prematurely withdrawn or lost to follow-up) in each part of the study have completed a visit at month 12 and 30 days of safety follow-up.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Macitentan
Macitentan in combination with dose-dense temozolomide
干预措施: Phase 1 Dose Escalation (Drug)
Macitentan
Macitentan in combination with dose-dense temozolomide
干预措施: Phase 1b (Drug)
Macitentan
Macitentan in combination with dose-dense temozolomide
干预措施: Ancillary Study (Drug)
结局指标
主要结局
To determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide
时间窗: Phase I Dose Escalation period (Dose-Limiting Toxicity from Baseline to 28 days for each dose level)
次要结局
- Number of patients with treatment-emergent adverse events (AEs) and serious AEs(Participants will be followed up for the duration of combination treatment, an expected average of 9-12 months.)
- Incidence of treatment-emergent* marked laboratory abnormalities(Participants will be followed up for the duration of combination treatment, an expected average of 9-12 months.)
- Occurrence of at least grade 2 ALT and/or AST elevation(Participants will be followed up for the duration of combination treatment, an expected average of 9-12 months.)
- Number of patients with treatment-emergent ECG abnormalities(Up to 30 days after discontinuation of macitentan)
- Change from baseline in vital signs(Up to 30 days after discontinuation of macitentan)
- Number of patients with AEs leading to premature discontinuation of study treatment(Participants will be followed up for the duration of combination treatment, an expected average of 9-12 months.)