A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 246
- 主要终点
- Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
研究概览
简要总结
Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
- •Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •All scans used to document complete response must be done within 30 days prior to randomization.
- •Patients must be able to swallow and retain oral medication.
排除标准
- •Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).
- •Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
- •Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
- •Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006)
Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Placebo
Participants received 2 matching placebo tablets per oral twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment
时间窗: From randomization of the first patient until 32.5 months later, assessed every 8 weeks
Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.
次要结局
- Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level(From randomization of the first patient until 32.5 months later, assessed every 8 weeks)
- Overall Survival (OS)(From randomization of the first patient until 32.5 months later)