NCT01536145已完成1 期
An Open Label Phase I Study Of CP-751,871 In Patients With Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
This study represents the first-in-human study for CP-751,871. The study aimed to define the safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple myeloma through a dose escalation design.
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
- •Previously treated multiple myeloma with a quantifiable serum (M spike ≥ 1 g/dL) and/or urine (≥ 200 mg/24-hr) paraprotein
- •Adequate bone marrow, renal, liver and cardiac function
- •Eastern Cooperative Oncology Group [ECOG] performance status less than or equal to 2
排除标准
- •Prior allogeneic stem cell transplant (alloSCT)
- •Myelosuppressive chemotherapy or immunotherapy within 3 weeks prior to treatment with CP-751,871
- •Prior organ allograft
- •Concurrent use of insulin, oral hypoglycemic medication, growth hormone (GH), or growth hormone inhibitors
- •Female patients who are pregnant or lactating
研究组 & 干预措施
Single agent CP-751,871
Experimental
dose escalation design
干预措施: CP-751,871 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Baseline up to Cycle 1 (Week 4 or Week 8)
The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants
次要结局
- Single Dose End-of-infusion Concentration (Cinf) for CP-751,871(1 hour postdose in Cycle 1)
- Single Dose Volume of Distribution (Vz) for CP-751,871(Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose)
- Single Dose Plasma Decay Half-life (t1/2) for CP-751,871(Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose)
- Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871(Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose)
- Multiple Dose Cinf for CP-751,871(1 hour postdose in Cycles 2 up to 16)
- Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871(Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose)
- Single Dose Systemic Clearance (CL) for CP-751,871(Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose)
- Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871(0 hour (predose) in Cycles 2 up to 16)
- Human Anti-human Antibody (HAHA) Response to CP-751,871(30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg)
- Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871(Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose)
- Pharmacodynamic-based Dose(Cycle 1 (Week 4 or Week 8))
- Percentage of Participants With Objective Response (OR)(Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose))
- Time to Disease Progression(Baseline up to end of treatment)
研究者
研究点 (1)
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