A Randomized, Open-label Study of the Effect of Omnitarg in Combination With Carboplatin-based Chemotherapy Versus Carboplatin-based Therapy Alone on Treatment Response in Patients With Platinum-sensitive Recurrent Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 149
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;
- •only 1 previous regimen, which must be platinum-based;
- •platinum-sensitive disease which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.
排除标准
- •previous radiotherapy;
- •previous treatment with an anti-cancer vaccine or any targeted therapy;
- •major surgery or traumatic injury within 4 weeks of study;
- •history or evidence of central nervous system metastases.
研究组 & 干预措施
Chemotherapy + Pertuzumab
干预措施: pertuzumab (Drug)
Chemotherapy + Pertuzumab
干预措施: paclitaxel (Drug)
Chemotherapy + Pertuzumab
干预措施: gemcitabine (Drug)
Chemotherapy + Pertuzumab
干预措施: carboplatin (Drug)
Chemotherapy
干预措施: paclitaxel (Drug)
Chemotherapy
干预措施: gemcitabine (Drug)
Chemotherapy
干预措施: carboplatin (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
Kaplan-Meier Probability of No Disease or Progression at 1 Year
时间窗: 1 year
The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.
Percentage of Participants With Disease Progression or Death
时间窗: Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks
Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.
次要结局
- Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year(1 year)
- Percentage of Participants With Disease Progression(Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression)
- Duration of Response(Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks)
- Time to Progressive Disease(Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression)
- Percentage of Participants Who Died(Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment)
- Overall Survival(Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment)
- Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements(Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks)
- Kaplan-Meier Probability of Being Progression Free at 1 Year(1 year)
- Time To Response(Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment)
- Kaplan-Meier Probability of Being Alive at 1 Year(1 year)