EUCTR2014-001764-35-ES进行中（未招募）1 期
A Phase 1 Dose Escalation and Phase 2 Randomized Double-Blind Study of Veliparib in Combination with Carboplatin and Etoposide as a Therapy of Treatment-Naïve Extensive Stage Disease Small Cell Lung Cancer.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Phase 2 subjects must have histologically or cytologically confirmed ED SCLC with measurable disease.
- •-ECOG performance score 0 or 1.
- •-Phase 1 subjects may have other pre-defined small cell tumors but measurable disease is not required.
- •-Subjects must have adequate hematologic, renal and hepatic function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •-Subject has had any prior chemotherapy, radiotherapy, investigations anti-cancer agents or biologic therapy for SCLC.
- •-Subject has known hypersensitivity to etoposide or platinum agents.
- •-Subject currently has or has a history of central nervous system (CNS) or leptomeningeal metastasis.
- •-Subject has a history or seizures within 12 months of first dose of study drug.
- •Subject has history of hepatitis B or C within 3 months of screening.
研究者
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