A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab) in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Morphotek
- 入组人数
- 415
- 试验地点
- 61
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003 (farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer
详细描述
Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks prior to study entry
- •Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically within 6 months of most recent platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.
- •Must have been treated with debulking surgery and at least one line platinum-based chemotherapy;
- •Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance.
- •Subjects must be candidate for repeat paclitaxel treatment
排除标准
- •Clinical contraindications to use of paclitaxel, which include:
- •persistent Grade 2 or greater peripheral neuropathy
- •prior hypersensitivity reaction that persisted despite rechallenge with or without desensitization or resulted in bronchospasm or hemodynamic instability or was at least Grade 2 and resulted in medication discontinuation
- •Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that has been surgically resected is acceptable provided the subject did
- •Prior radiation therapy is excluded with the exception that it is allowable only if measurable disease for ovarian cancer is completely outside the radiation portal
- •Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA).
- •Previous treatment with MORAb-003 (farletuzumab).
研究组 & 干预措施
1
MORAb-003 (Farletuzumab) Plus Paclitaxel
干预措施: MORAb-003 (farletuzumab) (Drug)
1
MORAb-003 (Farletuzumab) Plus Paclitaxel
干预措施: Paclitaxel (Drug)
2
Placebo Plus Paclitaxel
干预措施: 0.9% Saline (Drug)
2
Placebo Plus Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
Overall Survival (OS)
时间窗: Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
次要结局
- Best Overall Response(Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months)
- Time to Tumor Response (TTR)(Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months)