Phase 1, Dose Escalation Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 19
- 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
Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of advanced non-small cell lung cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Any prior treatment for non-small cell lung cancer
- •Brain metastases
- •With diabetes
研究组 & 干预措施
CP-751,871
干预措施: CP-751,871 + carboplatin + paclitaxel (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLT)
时间窗: Cycle 1
A DLT was defined as any one of the following adverse events observed in Cycle 1 which was considered as related to CP-751,871 combination therapy; 1) \>=Grade 3 gastrointestinal toxicity, hyperglycemia and/or fatigue despite the use of adequate/optimal medical intervention, 2) Any other \>=Grade 3 toxicity not classified under CTCAE blood/bone marrow, or 3) Grade 4 neutropenia that persisted for \>=7 consecutive days or was complicated by fever (defined as a body temperature \>38.0 Celsius degree), 4) Grade 3 thrombocytopenia which needed blood transfusion or Grade 4 thrombocytopenia.
次要结局
- Maximum Observed Concentration (Cmax) of CP-751,871(Cycles 1 and 4 at prior to dosing of CP-751,871 (Day 1), and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion)
- Plasma Decay Half-Life (t1/2)(Cycle 1 : prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion)
- Area Under the Plasma Concentration-time Curve From Time 0 to Day 22 (AUC0-day22)(Cycle 1: prior CP-751,871 (Day 1) to dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion)
- Area Under the Plasma Concentration Curve From Time Zero to Tau (AUCtau)(Cycle 4: prior to CP-751,871 (Day 1) dosing , and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion)
- Observed Accumulation Ratio (Rac)(Cycle 1 and Cycle 4: prior to CP-751,871 (Day 1) dosing, and 1, 24, 72 and 168 (Day 8) hours after end of CP-751,871 infusion)
- Serum Concentrations of Total Insulin-like Growth Factor 1 (IGF-1)(Day 1 of Cycles 1 to 6, Day 8 of Cycles 1 to 4, and end of study)
- Serum Concentrations of Total Insulin-like Growth Factor Binding Protein-3 (IGF-BP-3)(Day 1 of Cycles 1-6, Day 8 of Cycles 1-4, and end of treatment)
- Number of Participants With Positive Anti-Drug Antibody (ADA) Specific to CP-751,871 Following an Intravenous Infusion of CP-751,871.(Day 1 of Cycles 1 (predose) and 4, and end of study)
- Number of Participants With Objective Response(Baseline up to 6 cycles (1 cycle = 21 days))
- Progression-Free Survival (PFS)(Baseline up to 6 cycles (1 cycle = 21 days))