NCT00088556已完成1 期
Phase 1-2a Dose-Ranging Study of the Triplet Combination of Carboplatin, Paclitaxel and TLK286 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
Telik27 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2004年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 27
- 主要终点
- Study Objectives
研究概览
简要总结
The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Histologically confirmed non-small cell lung cancer (NSCLC)
- •Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
- •Measurable disease by RECIST
- •ECOG status of 0-1
- •Adequate liver and renal function
- •Adequate bone marrow reserves
排除标准
- •Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
- •Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
- •History of bone marrow transplantation or stem cell support
- •Pregnant or lactating women
研究组 & 干预措施
Triplet Combination of TLK286 Carboplatin & Paclitaxel
Experimental
Experimental
干预措施: TLK286 (Drug)
Triplet Combination of TLK286 Carboplatin & Paclitaxel
Experimental
Experimental
干预措施: carboplatin (Drug)
Triplet Combination of TLK286 Carboplatin & Paclitaxel
Experimental
Experimental
干预措施: paclitaxel (Drug)
结局指标
主要结局
Study Objectives
时间窗: Every 6 Weeks
1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin
次要结局
未报告次要终点
研究者
研究点 (27)
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