Phase 2, 2-Part, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of CT-322 Monotherapy and Combination Therapy With Irinotecan in Patients With Recurrent Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 试验地点
- 10
- 主要终点
- Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1)
研究概览
简要总结
RATIONALE: CT-322 may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving CT-322 together with irinotecan may kill more tumor cells.
PURPOSE: This phase 2 trial is studying the side effects, tolerability, and efficacy of CT-322 when given alone and in combination with irinotecan to patients with glioblastoma multiforme.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
CT-322
干预措施: CT-322 (Drug)
2
CT-322 and irinotecan hydrochloride
干预措施: CT-322 (Drug)
2
CT-322 and irinotecan hydrochloride
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1)
时间窗: 15 ± 5 days post the last dose of study drug
Progression-free survival at 6 months (Part 2)
时间窗: Measured upon initiation of cycles 2, 3, 5, 7, 9, 11, and end of study
次要结局
- To assess the plasma pharmacokinetics of CT-322 (Cmax, Tmax, AUC, T-HALF) derived from plasma concentration vs time for CT-322 given alone and in combination with irinotecan(Part 1: cycle 1, days 1-3, day 5 or 6, days 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits. Part 2: cycle 1, days 1, 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits.)
- To assess the presence of anti CT-322 antibodies(Part 1: cycle 1, days 1 and 15; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits. Part 2: cycle 1, days 1 and 15; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits.)
- To assess the biological activity of CT-322 as measured by plasma biological markers and neuroimaging(Part 1: cycle 1, days 1, 2, 8, 15 and 22; cycles 2-4, 6, 9, and 12, day 1; EOS visit. Part 2: cycle 1, days 1, 8, 15 and 22; cycles 2-4, 6, 9, and 12 EOS visit.)