EUCTR2016-001659-32-CZ进行中（未招募）1 期
A Phase 1 Dose Escalation and Phase 2 Randomized, Placebo-Controlled Study of the Efficacy and Tolerability of Veliparib in Combination with Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects with Stage III Non-Small Cell Lung Cancer (NSCLC)Eskalace dávky fáze 1 a randomizované, placebem kontrolované klinické hodnocení fáze 2 stanovující úcinnost a snášenlivost veliparibu v kombinaci s chemoradioterapií na bázi paklitaxelu/karboplatiny následovanou konsolidacní terapií veliparibem a paklitaxelem/karboplatinou u pacientu s nemalobunecným karcinomem plic (NSCLC) stádia III
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 186
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
- 性别
- All
入选标准
- •1. Participants with Histologically or cytologically confirmed Stage III non-small cell lung cancer (NSCLC).
- •2. Participants in the randomized portion of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.
- •3. Participants must have V20 (volume of lung to receive 20 Gy radiotherapy according to simulation) < 35%.
- •4. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 – 1.
- •5. Participant must have adequate hematologic, renal, hepatic, and lung 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 93
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 93
排除标准
- •1. Participants with prior chemotherapy or radiotherapy (RT) for current NSCLC. Participants curatively treated for past early stage NSCLC greater than 3 years ago may be included.
- •2. Participants with prior exposure to poly-ADP-ribose polymerase (PARP) inhibitors.
- •3. Participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (Cremophor).
- •4. Participants with prior mediastinal or thoracic radiotherapy. Prior tangential RT to prior breast cancer is acceptable.
- •5. Participants with major surgery in the 4 weeks prior to randomization (Video-assisted thoracoscopic surgery (VATS) and/or mediastinoscopy is not considered major surgery).
研究者
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