A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 184
- 试验地点
- 29
- 主要终点
- Hazard ratio for PFS in Arm A vs Arm B
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of CC-90010 when combined with standard of care treatment, temozolomide (TMZ) with or without radiotherapy (RT) in the newly diagnosed WHO Grade IV glioblastoma (ndGBM).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma
- •O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization
- •Karnofsky performance status of ≥70
排除标准
- •Indeterminate MGMT promoter methylation status
- •Biopsy only of glioblastoma (GBM) at surgery, defined as < 20% resection of enhancing tumor
- •Any known metastatic extracranial or leptomeningeal disease
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A
干预措施: CC-90010 (Drug)
Part A
干预措施: Temozolomide (Drug)
Part A
干预措施: Radiotherapy (Radiation)
Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)
干预措施: CC-90010 (Drug)
Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)
干预措施: Temozolomide (Drug)
Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)
干预措施: Radiotherapy (Radiation)
Part B - Standard TMZ + RT
Control
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Hazard ratio for PFS in Arm A vs Arm B
时间窗: Up to 12 months
Part B
Incidence of dose-limiting toxicities (DLTs)
时间窗: Up to 3 years
Part A
Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)
时间窗: Up to 3 years
Part A
MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)
时间窗: Up to 3 years
Part A
Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ
时间窗: Up to 3 years
Part A
Median Progression-free survival (PFS) in Arm A vs Arm B
时间窗: Up to 12 months
Part B
Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0
时间窗: Up to 3 years
Parts A and B
Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
时间窗: Up to 3 years
Parts A and B
RP2D of CC-90010 in combination with TMZ and RT
时间窗: Up to 3 years
Part A
次要结局
- Response by Response Assessment in Neuro-Oncology (RANO) criteria(Up to 5 years)
- Pharmacokinetics - Time to maximum plasma concentration (Tmax)(Up to 2 years)
- Progression-free survival (PFS) defined as the time from the first dose of CC-90010 to the first occurrence of disease progression or death from any cause(Up to 5 years)
- Duration of therapy (DoT) in Arm A vs Arm B(Up to 5 years)
- Pharmacokinetics - Area under the plasma concentration time-curve (AUC)(Up to 2 years)
- Overall survival (OS) measured as the time from the first dose of CC-90010 to death due to any cause and will be analyzed in a manner similar to that described for PFS(Up to 5 years)
- Pharmacokinetics - Maximum observed plasma concentration (Cmax)(Up to 2 years)