A Phase II Randomized Open Label Study of MM-121 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Platinum Resistant/ Refractory Advanced Ovarian Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 10
- 主要终点
- Progression Free Survival
研究概览
简要总结
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
详细描述
This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.
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
- •Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- •Received at least one prior platinum based chemotherapy regimen
- •Platinum-resistant or refractory
- •Eligible for weekly paclitaxel
- •Adequate liver and kidney function
- •18 years of age or above
排除标准
- •Evidence of any other active malignancy
- •History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL
研究组 & 干预措施
Paclitaxel
Standard dosing paclitaxel: 80 mg/m2 QW intravenously)
干预措施: Paclitaxel (Drug)
MM-121 (SAR256212) + Paclitaxel
administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
干预措施: MM-121 (Drug)
MM-121 (SAR256212) + Paclitaxel
administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Time from first dose to date of progression, the longest time frame of 3.9 years
To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
次要结局
- Overall Survival(Time from first dose to date of death, with a median of approximately 13 months)