A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,224
- 试验地点
- 1
- 主要终点
- Overall Survival Time
研究概览
简要总结
Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC).
The secondary objectives were:
- To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);
- To assess the overall safety in both treatment arms;
- To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;
- to determine immunogenicity of IV aflibercept.
详细描述
The study consisted in 3-week treatment cycles until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. After disease progression, participants were to be followed every 3 months until death or the study cutoff date, whichever came first.
The study cut-off date was event-driven and was defined as the date when 873 deaths had occurred.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically-confirmed prostate adenocarcinoma;
- •Metastatic disease;
- •Progressive disease while receiving hormonal therapy or after surgical castration;
- •Effective castration.
排除标准
- •Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago;
- •Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF receptor inhibitors;
- •Eastern Cooperative Oncology Group (ECOG) performance status >
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone
干预措施: Placebo (for aflibercept) (Drug)
Placebo
Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone
干预措施: Docetaxel (Drug)
Placebo
Placebo added to standard chemotherapy with docetaxel plus prednisone or prednisolone
干预措施: Prednisone or Prednisolone (Drug)
Aflibercept
Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone
干预措施: Aflibercept (Drug)
Aflibercept
Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone
干预措施: Docetaxel (Drug)
Aflibercept
Aflibercept added to standard chemotherapy with docetaxel plus prednisone or prednisolone
干预措施: Prednisone or Prednisolone (Drug)
结局指标
主要结局
Overall Survival Time
时间窗: From randomization up to the cut-off date (median follow-up of 35.4 months)
Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause. The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier.
次要结局
- Time to Skeletal Related Events(From randomization up to the cut-off date (median follow-up of 35.4 months))
- Prostate Specific Antigen Response Rate(Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first)
- Pain Response Rate(Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first)
- Progression Free Survival Time(From randomization up to the cut-off date (median follow-up of 35.4 months))
- Number of Participants With Adverse Events as a Measure of Safety(From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days)
- Prostate Specific Antigen Progression-free Survival Time(From randomization up to the cut-off date (median follow-up of 35.4 months))
- Pain Progression-free Survival Time(From randomization up to the cut-off date (median follow-up of 35.4 months))
- Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept(Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug)
- Tumor Response Rate in Participants With Measurable Disease(Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first)
- Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life(Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first)