NCT00421044已完成1 期
An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
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
- 14
- 试验地点
- 3
- 主要终点
- Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values
研究概览
简要总结
Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Completion of the core study is required for participation in the extension.
- •18 years of age or older
- •World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
- •Life expectancy of 3 months or more
- •Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist
排除标准
- •Severe and/or uncontrolled medical disease
- •Known diagnosis of human immunodeficiency virus (HIV) infection
- •Presence of any other active or suspected acute or chronic uncontrolled infection
- •Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
- •History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Arm A (Normal liver function)
Experimental
干预措施: Patupilone/EPO906 (Drug)
Arm B (Mild liver dysfunction)
Experimental
干预措施: Patupilone/EPO906 (Drug)
Arm C (Moderate liver dysfunction)
Experimental
干预措施: Patupilone/EPO906 (Drug)
结局指标
主要结局
Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values
时间窗: at completion of the study
To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks
时间窗: at completion of the study
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
终止
1 期
Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMMMultiple MyelomaNCT03481556Oncopeptides AB56
终止
1 期
A Study Explore JS001+JS002 in Patients With Advanced CancerAdvanced CancerNCT05128539Shanghai Junshi Bioscience Co., Ltd.9
已完成
1 期
A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal TumorsGastrointestinal Stromal TumorNCT02686944Mendus6
终止
1 期
A Prospective, Open Label, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus DiseaseAcute Ebola Virus DiseaseNCT02295501Cerus Corporation6
已完成
不适用
A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)Nonalcoholic Steatohepatitis (NASH)NCT05320146Corcept Therapeutics22