A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 161
- 主要终点
- Progression Free Survival
研究概览
简要总结
This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome Measure:
• Progression free survival (PFS)
Secondary Outcome Measures:
- Object Response Rate (ORR), duration of response (DOR). CA-125 response rate
- Safety and Tolerability
- Change and duration of change on blood levels of CA-125
详细描述
Primary Objective:
To estimate the treatment effect as measured by progression free survival (PFS) of subjects with recurrent ovarian cancer receiving AMG 386 (either 3 mg/kg or 10 mg/kg IV QW) in combination with paclitaxel (80 mg/m2 IV QW; 3 on/1 off)compared to subjects receiving paclitaxel (80 mg/m2 IV QW; 3 on/1 off) plus placebo
Secondary Objective(s):
- To evaluate the safety and tolerability of the combination regimen of AMG 386/paclitaxel
- To estimate other measures of treatment effect (by parameters other than PFS) of subjects receiving AMG 386 in combination with paclitaxel compared to subjects receiving paclitaxel plus placebo
- To evaluate the AMG 386 pharmacokinetics parameters (Cmax and Cmin ) when administered with paclitaxel in subjects with recurrent ovarian cancer
- To estimate the incidence of occurrence of anti-AMG 386 antibody formation
- To estimate the change and duration of change on blood levels of CA-125
- To evaluate the clinical benefit among subjects receiving AMG 386 10 mg/kg monotherapy after disease progression on paclitaxel
- To estimate the impact of AMG 386 on patient reported ovarian cancer specific symptoms and HRQoL using the FACT-O, the FACT-O ovarian cancer subscale (OCS), and the FACT-O 3-item (O1, O2, O3) cancer symptom specific subscale (OCS 3-item subscale)
Exploratory Objective(s):
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 10 mg/kg IV QW
干预措施: AMG 386 (Drug)
Arm A
Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 10 mg/kg IV QW
干预措施: Paclitaxel (Drug)
Arm B
Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 3 mg/kg IV QW
干预措施: AMG 386 (Drug)
Arm B
Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 3 mg/kg IV QW
干预措施: Paclitaxel (Drug)
Arm C
Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 placebo
干预措施: Paclitaxel (Drug)
Arm C
Paclitaxel 80 mg/m2 IV QW (3 on/1 off) + AMG 386 placebo
干预措施: AMG 386 Placebo (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 2 years
次要结局
- Change from baseline in blood levels of CA-125(2 years)
- AMG 386 Pharmacokinetic parameters(2 years)
- Objective Response Rate(2 years)
- Modified RECIST/CA-125 Progression Free Survival(2 years)
- Time to Progression(2 years)
- Duration of Response(2 years)
- Safety and Tolerability(2 years)
- Estimate of reduction in tumor burden(2 years)
- Incidence of AEs and significant laboratory changes(2 years)
- Incidence of the occurence of AMG 386 Antibody formation(2 years)
- CA-125 Response Rate(2 years)
- Overall Survival(2 years)
- Time to Response(2 years)
- Time-adjusted area under the curve for PROs(2 years)