Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 210
- 试验地点
- 18
- 主要终点
- Determine the MTD (Phase 1) and ORR (Phase 2).
研究概览
简要总结
The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
QDx2 Dosing Schedule
QDx2 is defined as patients receiving Oprozomib Tablets once daily on Days 1, 2, 8, and 9 of the 14-day cycle.
The schedule will be evaluated in Phase 1 for MTD in patients with hematologic malignancies, and will also be evaluated in Phase 2 for ORR in patients with MM and WM.
干预措施: oprozomib (Drug)
QDx5 Dosing Schedule
QDx5 is defined as patients receiving Oprozomib Tablets once daily on Days 1 to 5 of the 14-day cycle.
The schedule will be evaluated in Phase 1 for MTD in patients with hematologic malignancies, and will also be evaluated in Phase 2 for ORR in patients with MM and WM.
干预措施: oprozomib (Drug)
结局指标
主要结局
Determine the MTD (Phase 1) and ORR (Phase 2).
时间窗: 6 weeks to 18 months
Phase 1- Determine Maximum Tolerated Dose (MTD) with 3 + 3 Dose Escalation Cohorts in patients hematologic malignancies. Phase 2- The Phase 2 portion of this trial will enroll patients with Multiple Myeloma (MM) and Waldenstrom Macroglobulinemia (WM) into separate arms to assess activity of oprozomib in these patient groups. The purpose of the Phase 2 portion of the study is to estimate the best ORR (for each group separately).
次要结局
- Evaluate the duration of response (DOR)(64 months)
- Estimate the clinical benefit response (CBR)(64 months)
- Estimate the major response for Waldenström macroglobulinemia (WM)(64 months)
- Evaluate progression-free survival (PFS) for multiple myeloma (MM) subjects(64 months)
- Evaluate the PFS for Waldenström macroglobulinemia (WM) subjects(64 months)
- PK parameters - maximum plasma concentration (Cmax)(55 months)
- PK parameters - time of maximum plasma concentration (tmax)(55 months)
- PK parameters - plasma concentration-time curve (AUC)(55 months)
- Assess renal elimination of oprozomib and its metabolites (Phase 1b only)(55 months)
- Change from Baseline in hematology laboratory results(64 months)
- Change from Baseline in weight(64 months)
- Assess the effect on transfusion/ red blood cell (RBC) growth factor requirements (Phase 2 only) for WM only(64 months)
- Change from Baseline in serum chemistry results(64 months)
- Change from Baseline in vital signs(64 months)
- Evaluate safety of oprozomib in Phase 2(Until 30 days after the end of study (64 months))
- Assess the effect on plasmapheresis requirements (Phase 2 only) for WM only(64 months)
- Assess the effect on lymphoplasmacytic cells in the bone marrow (Phase 2 only) for WM only(64 months)