NCT00410358已完成1 期
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Estimated Maximum Tolerated Dose of gimatecan
研究概览
简要总结
This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.
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
- •Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists.
- •Life expectancy of at least 3 months
- •Adequate hematological parameters
- •No major impairment of renal and hepatic function
排除标准
- •Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption.
- •Patients who have received any investigational compound within the past 28 days.
- •Patients with other antineoplastic therapy within the last 28 days.
- •Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection
- •Patients with a history of allergies to the camptothecin family drug.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LBQ707
Experimental
干预措施: Gimatecan (Drug)
结局指标
主要结局
Estimated Maximum Tolerated Dose of gimatecan
时间窗: 1.8 years
次要结局
- Anti-tumor activity assessed by RECIST(1.8 years)
- Safety assessed by adverse events(1.8 years)
- Characterization of the pharmacokinetic profile of gimatecan(1.8 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT00487058Novartis28
已完成
1 期
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid TumorAdvanced Solid TumorsNCT00441610Novartis Pharmaceuticals4
Unknown
1 期
A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal CancerOvarian Epithelial CancerFallopian Tube CancerPrimary Peritoneal CancerNCT04029909Lee's Pharmaceutical Limited12
已完成
1 期
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid TumorsSolid TumorsNCT00420485Novartis Pharmaceuticals120
已完成
1 期
A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male SubjectsHealthy VolunteersNCT01258777Centocor, Inc.49