NCT00474760已完成1 期
Phase 1, Open Label, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP 751,871 In Patients With Advanced Solid Tumors
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
- 65
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Ewing's sarcoma family tumors
排除标准
- •Concurrent treatment with any other anti tumor agents
研究组 & 干预措施
1
Experimental
干预措施: CP-751,871 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 150 days after the last administration of study drug
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
次要结局
- Plasma Decay Half-Life (t1/2) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Plasma Decay Half-Life (t1/2) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Systemic Clearance (CL) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Maximum Observed Plasma Concentration (Cmax) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Maximum Observed Plasma Concentration (Cmax) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Concentration at End of Infusion (Cendinf) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Systemic Clearance (CL) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Concentration at End of Infusion (Cendinf) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Volume of Distribution (Vz) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Volume of Distribution (Vz) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Volume of Distribution at Steady State (Vss) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Volume of Distribution at Steady State (Vss) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1(Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4(Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose)
- Human Anti-human Antibodies (HAHA) Levels(30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug))
- Number of Circulating Tumor Cells (CTCs)(30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort)
- Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs(30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort)
研究者
研究点 (1)
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