NCT02210364已完成1 期
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC)
PharmaMar0 个研究点目标入组 81 人开始时间: 2013年4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
- 81
- 主要终点
- Recommended dose of PM01183 in combination with capecitabine
研究概览
简要总结
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety profile, to explore the feasibility of PM01183 dose optimization, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed and dated written informed consent (IC)
- •Age between 18 and 75 years
- •Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry.
- •Life expectancy ≥ 3 months.
- •Patients with a histologically/cytologically confirmed diagnosis of unresectable Metastatic Breast Cancer, Pancreatic Cancer or metastatic Colorectal Cancer.
排除标准
- •Three or more prior chemotherapy-containing lines for advanced disease.
- •Prior treatment with PM01183 or with capecitabine containing therapy for advanced disease.
- •History within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment.
- •Ongoing chronic hepatopathy of any origin.
- •Active uncontrolled infection.
- •Patients with dyspnea who are requiring any ongoing oxygen support.
- •Known human immunodeficiency virus (HIV) infection.
- •Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
- •Men or women of childbearing potential who are not using an effective method of contraception
研究组 & 干预措施
lurbinectedin (PM01183) and capecitabine
Experimental
干预措施: lurbinectedin (PM01183) (Drug)
lurbinectedin (PM01183) and capecitabine
Experimental
干预措施: capecitabine (Drug)
结局指标
主要结局
Recommended dose of PM01183 in combination with capecitabine
时间窗: 30 months
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid TumorsAdvanced Solid TumorsSoft Tissue Sarcoma (Excluding GIST)Endometrial CarcinomaEpithelial Ovarian CarcinomaMesotheliomaGastroenteropancreatic Neuroendocrine TumorGastric CarcinomaPancreatic AdenocarcinomaColorectal CarcinomaNeuroendocrine TumorsGlioblastomaSCLCNCT02611024PharmaMar316
已完成
1 期
Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid TumorsAdvanced Solid TumorsNCT01980667PharmaMar41
进行中（未招募）
3 期
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung CancerSmall-Cell Lung CancerNCT05091567Hoffmann-La Roche660
撤回
1 期
Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue SarcomasLocally Advanced Soft Tissue SarcomaNCT06217536University of California, San Francisco70
进行中（未招募）
1 期
Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients with Solid TumorsEUCTR2015-000206-18-ESPharmaMar S.A., Sociedad Unipersonal25