Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 442
- 试验地点
- 28
- 主要终点
- Progression-free Survival by Independent Review Committee
研究概览
简要总结
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age >/= 18 years
- •Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer.
- •Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy).
- •Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria
- •No more than three prior systemic chemotherapy regimens
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2
- •Adequate hematological, renal, metabolic and hepatic function
排除标准
- •Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness
- •Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.
- •Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization
研究组 & 干预措施
Arm A
lurbinectedin (PM01183)
干预措施: Lurbinectedin (PM01183) (Drug)
Arm B
pegylated liposomal doxorubicin
OR
topotecan
干预措施: Pegylated liposomal doxorubicin (PLD) (Drug)
Arm B
pegylated liposomal doxorubicin
OR
topotecan
干预措施: Topotecan (Drug)
结局指标
主要结局
Progression-free Survival by Independent Review Committee
时间窗: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
The primary endpoint was PFS by IRC assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.
次要结局
- Progression-free Survival by Investigator's Assessment(Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years)
- Overall Survival (OS)(From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years)
- Overall Response Rate (ORR) by Independent Review Committee(At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years)
- Overall Response Rate by Investigator's Assessment(At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years)
- Duration of Response by Independent Review Committee(The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years)
- Duration of Response by Investigator's Assessment(The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years)
- Best Response According to Tumor Marker Evaluation (CA-125)(At baseline and every eight weeks from randomization until evidence of PD, up to 3 years)