NCT00424775终止1 期
A Phase I Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Number of Participants With a Dose Limited Toxicity at First Cycle
研究概览
简要总结
The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC with stage IIIB (not applicable of radical thoracic radiation) or stage IV
- •Patients with normal organ function and bone marrow function
排除标准
- •Given radical thoracic radiation for NSCLC or radiation for other than original lesion within 3 weeks
- •Any peripheral neuropathy above grade 2
- •Any ascites, pleural effusion or pericardiac effusion which requires treatment
- •Any uncontrolled concomitant illness
- •Pregnant or breast-feeding
结局指标
主要结局
Number of Participants With a Dose Limited Toxicity at First Cycle
时间窗: 25 Days (first cycle)
Dose Limited Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment.
次要结局
- Maximum Concentration (Cmax) at Day 4(Day 4)
- Maximum Concentration (Cmax) at Day 5(Day 5)
- Area Under the Curve (AUC(0-24 hr)) at Day 4(Day 4)
- Area Under the Curve (AUC(0-24 hr)) at Day 5(Day 5)
研究者
相似试验
已完成
1 期
Carboplatin/Taxol/Ridaforolimus in Endometrial, Ovarian and SolidsEndometrial CancerOvarian CancerNCT01256268H. Lee Moffitt Cancer Center and Research Institute24
已完成
2 期
Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary SiteNeoplasm, Unknown PrimaryNCT00360360SCRI Development Innovations, LLC60
已完成
2 期
Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial CarcinomaEndometrial CancerNCT00513786David O'Malley38
终止
2 期
Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate CancerProstate CancerNCT01558492Weill Medical College of Cornell University3
已完成
2 期
Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast CancerMetastatic Triple Negative Breast CancerNCT03121352Case Comprehensive Cancer Center30