A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 345
- 试验地点
- 40
- 主要终点
- Response by Investigator Assessment
研究概览
简要总结
Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors
详细描述
Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Voluntary signed informed consent (IC)
- •Pathologically proven diagnosis of any of the following malignancies:
- •Small cell lung cancer (SCLC).
- •Head and neck carcinoma (H&N). Salivary glands tumors are excluded.
- •Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification.
- •Biliary tract carcinoma.
- •Endometrial carcinoma.
- •BRCA 1/2- associated metastatic breast carcinoma
- •Carcinoma of unknown primary site.
- •Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
- •Ewing's family of tumors (EFTs)
- •Prior treatment. Patients must have received:
- •SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
- •H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
- •GCTs: no limit of prior therapy
- •EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
- •BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
- •Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]
- •Adequate major organ function
- •At least three weeks since the last chemotherapy
- •Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry
排除标准
- •Prior treatment with PM01183 or trabectedin
- •Prior or concurrent malignant disease unless in complete remission for more than five years
- •Known central nervous system (CNS) involvement
- •Relevant diseases or clinical situations which may increase the patient's risk
- •Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception
研究组 & 干预措施
lurbinectedin (PM01183)
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
干预措施: lurbinectedin (PM01183) (Drug)
结局指标
主要结局
Response by Investigator Assessment
时间窗: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other). Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials.
Overall Response Rate (ORR)
时间窗: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD
次要结局
- Clinical Benefit(From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle))
- Disease Control Rate(From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6)
- Progression-free Survival at 4 Months(At 4 months)
- Progression-free Survival at 6 Months(At 6 months)
- Overall Survival (OS)(From the date of first infusion to the date of death or last contact, up to an average of 5 years)
- Overall Survival at 12 Months(At 12 months)
- Duration of Response(From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle))
- Progression Free Survival (PFS)(From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years)
- Overall Survival at 6 Months(At 6 months)