NCT01009190已完成1 期
A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014699) In Combination With Several Chemotherapeutic Regimens In Adult Patients With Advanced Solid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 6
- 主要终点
- Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)
研究概览
简要总结
Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors
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
- •Patients with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •Patients with acceptable renal, hepatic, and bone marrow function
排除标准
- •Symptomatic and/or unstable brain metastases,
- •Any cancer treatment within 4 weeks from study entry
研究组 & 干预措施
ARM A
Experimental
Carboplatin plus PF-01367338
干预措施: PF-01367338 (Drug)
ARM A
Experimental
Carboplatin plus PF-01367338
干预措施: Carboplatin (Drug)
ARM A EXPANSION
Experimental
Carboplatin plus PF-01367338
干预措施: PF-01367338 (Drug)
ARM A EXPANSION
Experimental
Carboplatin plus PF-01367338
干预措施: Carboplatin (Drug)
结局指标
主要结局
Safety and tolerability of escalating doses of PF-01367338 in combination with chemotherapy (as defined by first-cycle DLTs)
时间窗: 18 months
Dose-limiting toxicities and adverse events
次要结局
- Pharmacokinetics and pharmacodynamics of escalating doses of PF-01367338 in combination with several chemotherapeutic regimens(18 months)
- PARP activity and expression in peripheral blood lymphocytes (PBL)(18 months)
- Determination of food effect on oral PF-01367338 pharmacokinetics(18 month)
- Determination of effect of PF-013567338 administration on QTc prolongation test(18 months)
研究者
研究点 (6)
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