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A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer

Phase 3
Active, not recruiting
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BD0801+chemotherapydoxorubicin liposomeBD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Placebo+chemotherapydoxorubicin liposomePlacebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
BD0801+chemotherapyBD0801BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
BD0801+chemotherapyPaclitaxelBD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
BD0801+chemotherapyTopotecanBD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Placebo+chemotherapyPlaceboPlacebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Placebo+chemotherapyTopotecanPlacebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Placebo+chemotherapyPaclitaxelPlacebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Objective Response Rate (DOR) by investigator2 year

Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

ORR by BIRC2 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 BIRC2 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 investigator2 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 investigator2 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 investigator2 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 BIRC2 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 reaction2 year
Serum drug concentrations of BD08012 year

Serum drug concentrations of BD0801 will be calculated.

duration of immunogenicity positive reaction2 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

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