NCT00719524已完成1 期
An Open-label, Non-randomized, Dose Evaluation, Safety and Pharmacokinetics Phase I Study of AVE8062 in Combination With Platinum Salts (Cisplatin or Carboplatin) and Taxanes (Docetaxel or Paclitaxel), Every 3 Weeks, in Patients With Advanced Solid Tumors.
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
- Sanofi
- 入组人数
- 71
- 试验地点
- 3
- 主要终点
- Recommended dose of the combination based on Dose Limiting Toxicities observed
研究概览
简要总结
The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.
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
- •Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer.
- •Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
排除标准
- •Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
- •Absence of histologically or cytologically proven cancer at the first diagnosis.
- •Negative serum/urinary pregnancy test
- •Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: OMBRABULIN (AVE8062) (Drug)
结局指标
主要结局
Recommended dose of the combination based on Dose Limiting Toxicities observed
时间窗: Cycle 1
次要结局
- Overall safety profile(Treatment period)
- Pharmacokinetic profile(Cycle 1)
- Anti-tumor activity of the combination(Every 2 cycles)
研究者
研究点 (3)
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