A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
- Conditions
- Ovarian Cancer
- Interventions
- Registration Number
- NCT04908787
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 421
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BD0801+chemotherapy doxorubicin liposome BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. Placebo+chemotherapy doxorubicin liposome Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. BD0801+chemotherapy BD0801 BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. BD0801+chemotherapy Paclitaxel BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. BD0801+chemotherapy Topotecan BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. Placebo+chemotherapy Placebo Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. Placebo+chemotherapy Topotecan Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes. Placebo+chemotherapy Paclitaxel Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
- Primary Outcome Measures
Name Time Method Progression free survival(PFS) by blinded independent review committee(BIRC) 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
- Secondary Outcome Measures
Name Time Method Objective Response Rate (DOR) by investigator 2 year Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
ORR by BIRC 2 year Proportion of subjects who have a complete or partial response relative to baseline as assessed by BIRC according to RECIST 1.1 criteria
DCR by BIRC 2 year Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by BIRC according to RECIST 1.1 criteria
Objective Response Rate (ORR) by investigator 2 year Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Overall Survival (OS) 2.5 year OS is the time interval from the date of randomization to death from any cause.
PFS by investigator 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 investigator according to the RECIST1.1 criteria
Quality Of Life (QoL) 2.5 year use EORTC-QLQ-OV28 questionnaire
Disease Control Rate (DCR) by investigator 2 year Proportion of subjects who have a complete or partial response, or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria
DOR by BIRC 2 year Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
rate of immunogenicity positive reaction 2 year Serum drug concentrations of BD0801 2 year Serum drug concentrations of BD0801 will be calculated.
duration of immunogenicity positive reaction 2 year The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) 2.5 year Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Trial Locations
- Locations (1)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China