A Phase 3 interventional study of BD0801 and Paclitaxel in Ovarian Cancer, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Completed at 55 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 421 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Drug: BD0801 · Drug: Paclitaxel · Drug: Topotecan · Drug: doxorubicin liposome
Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Drug: Paclitaxel · Drug: Placebo · Drug: Topotecan · Drug: doxorubicin liposome
Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
Progression free survival(PFS) by blinded independent review committee(BIRC)
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
Time frame: 2 year
Overall Survival (OS)
OS is the time interval from the date of randomization to death from any cause.
Time frame: 2.5 year
PFS by investigator
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
Time frame: 2 year
Objective Response Rate (ORR) by investigator
Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Time frame: 2 year
Disease Control Rate (DCR) by investigator
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
Time frame: 2 year
Objective Response Rate (DOR) by investigator
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time frame: 2 year
ORR by BIRC
Proportion of subjects who have a complete or partial response relative to baseline as assessed by BIRC according to RECIST 1.1 criteria
Time frame: 2 year
DCR by BIRC
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
Time frame: 2 year
DOR by BIRC
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time frame: 2 year
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Time frame: 2.5 year
Quality Of Life (QoL)
use European Organisation for Research and Treatment of Cance（EORTC）- QLQ-C30 questionnaire
Time frame: 2.5 year
Quality Of Life (QoL)
use EORTC-QLQ-OV28 questionnaire
Time frame: 2.5 year
Serum drug concentrations of BD0801
Serum drug concentrations of BD0801 will be calculated.
Time frame: 2 year
rate of immunogenicity positive reaction
Time frame: 2 year
duration of immunogenicity positive reaction
Time frame: 2 year
Plan to share: No
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Jiangsu Simcere Pharmaceutical Co., Ltd.