A Randomized, Double-blind, Phase III Study of BD0801 Injection Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Patients With Recurrent, Platinum-resistant Epithelial Ovarian, Fallopian Tube , or Primary Peritoneal Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 55
- 主要终点
- Progression free survival(PFS) by blinded independent review committee(BIRC)
研究概览
简要总结
The standard systemic treatment for ovarian cancer is platinum-based chemotherapy. However, majority of patients relapse and eventually progress to platinum resistance. In patients with platinum-resistant or refractory ovarian cancer, effective treatment options are limited and the prognosis is very poor. Angiogenesis is essential for tumor growth and metastasis, and VEGF/VEGF receptor(VEGFR) signaling pathway is the most promising angiogenic target. This study aim to assess the efficacy and safety of the combination BD0801 and chemotherapy in patients with platinum-resistant recurrent ovarian cancer.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, >/=18 years of age;
- •epithelial ovarian, fallopian tube or primary peritoneal cancer;
- •platinum-resistant disease (disease progression within <6 months of platinum therapy)
- •Eastern Cooperative Oncology Group（ECOG）performance status of 0-1
排除标准
- •non-epithelial tumours
- •ovarian tumours with low malignant potential
- •Received 1 line of systemic therapy for ovarian cancer following platinum resistance and/or > 1 line of non-platinum systemic therapy prior to platinum resistance.
- •prior radiotherapy to the pelvis or abdomen
研究组 & 干预措施
Placebo+chemotherapy
Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
干预措施: Placebo (Drug)
BD0801+chemotherapy
BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
干预措施: BD0801 (Drug)
BD0801+chemotherapy
BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
干预措施: Paclitaxel (Drug)
BD0801+chemotherapy
BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
干预措施: Topotecan (Drug)
BD0801+chemotherapy
BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
干预措施: doxorubicin liposome (Drug)
Placebo+chemotherapy
Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
干预措施: Paclitaxel (Drug)
Placebo+chemotherapy
Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
干预措施: Topotecan (Drug)
Placebo+chemotherapy
Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
干预措施: doxorubicin liposome (Drug)
结局指标
主要结局
Progression free survival(PFS) by blinded independent review committee(BIRC)
时间窗: 2 year
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the IRC according to the RECIST 1.1 criteria
次要结局
- Objective Response Rate (DOR) by investigator(2 year)
- ORR by BIRC(2 year)
- DCR by BIRC(2 year)
- Objective Response Rate (ORR) by investigator(2 year)
- Overall Survival (OS)(2.5 year)
- PFS by investigator(2 year)
- Quality Of Life (QoL)(2.5 year)
- Disease Control Rate (DCR) by investigator(2 year)
- DOR by BIRC(2 year)
- rate of immunogenicity positive reaction(2 year)
- Serum drug concentrations of BD0801(2 year)
- duration of immunogenicity positive reaction(2 year)
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(2.5 year)