NCT00729833终止1 期
Phase 1, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib 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
- 终止
- 发起方
- Pfizer
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose-Limiting Toxicities (DLT)
研究概览
简要总结
The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.
详细描述
The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.
- •ECOG Performance Status of 0 or 1;
- •Total IGF-1 level ≥100 ng/ml;
- •ECOG Performance Status of 0 or 1
- •Adequate bone marrow, renal, and hepatic function
排除标准
- •Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients
- •Treatment with any other investigational therapy within 4 weeks prior to study treatment
- •Major surgery within 4 weeks of study treatment
- •Prior treatment that may increase the risk of cardiac complications
- •Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater
- •Significant active cardiac disease, including hypertension that cannot be controlled by medications
- •Greater than three (3) prior lines of cytotoxic therapy;
- •Active infection
- •Prior IGF-IR targeted therapy;
研究组 & 干预措施
CP-751,871 + Sunitinib
Experimental
Escalating cohorts of CP-751,871 + Sunitinib
干预措施: CP-751,871 (Drug)
CP-751,871 + Sunitinib
Experimental
Escalating cohorts of CP-751,871 + Sunitinib
干预措施: Sunitinib (Drug)
结局指标
主要结局
Number of Participants With Dose-Limiting Toxicities (DLT)
时间窗: Baseline up to the end of Cycle 1 (each cycle=3 weeks)
Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (\>=) 7 days delay in administration of Cycle 2. Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
次要结局
- Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0(Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose))
- Percentage of Participants With Hematologic Laboratory Test Abnormality(Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose))
- Percentage of Participants With Blood Chemistry Laboratory Test Abnormality(Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose))
- Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab(0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab(0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4)
- Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab(0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4)
- Plasma Decay Half-Life (t1/2) of Figitumumab(0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4)
- Maximum Observed Plasma Concentration (Cmax) of Sunitinib(0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib(0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1)
- Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib(0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1)
- Trough Plasma Concentration (Ctrough) of Sunitinib(0.5 hour predose on Day 1 of Cycle 2)
- Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib(24 hours postdose on Day 15 of Cycle 1)
- Number of Participants With Anti-Drug Antibodies (ADA)(0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug))
- Number of Participants With Objective Response (OR)(Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug))
研究者
研究点 (1)
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