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

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
BD0801
Paclitaxel
Placebo
Topotecan
doxorubicin liposome
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Exclusion Criteria:

  • non-epithelial tumours
  • ovarian tumours with low malignant potential
  • previous treatment with >2 chemotherapy regimens
  • prior radiotherapy to the pelvis or abdomen within 5 years

Sites / Locations

  • Cancer Hospital Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BD0801+chemotherapy

Placebo+chemotherapy

Arm Description

BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.

Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival (OS)
OS is the time interval from the date of randomization to death from any cause.
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
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
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
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.
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
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
DOR by BIRC
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
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
Quality Of Life (QoL)
use European Organisation for Research and Treatment of Cance（EORTC）- QLQ-C30 questionnaire
Quality Of Life (QoL)
use EORTC-QLQ-OV28 questionnaire
Serum drug concentrations of BD0801
Serum drug concentrations of BD0801 will be calculated.
rate of immunogenicity positive reaction
duration of immunogenicity positive reaction

Full Information

First Posted
May 27, 2021
Last Updated
December 28, 2022
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04908787
Brief Title
A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
357 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BD0801+chemotherapy
Arm Type
Experimental
Arm Description
BD0801 is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Arm Title
Placebo+chemotherapy
Arm Type
Placebo Comparator
Arm Description
Placebo is in combination with one of three chemotherapies: Paclitaxel, Topotecan or Doxorubicin liposomes.
Intervention Type
Drug
Intervention Name(s)
BD0801
Intervention Description
Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Description
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
Intervention Type
Drug
Intervention Name(s)
doxorubicin liposome
Intervention Description
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
Primary Outcome Measure Information:
Title
Progression free survival(PFS) by blinded independent review committee(BIRC)
Description
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
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is the time interval from the date of randomization to death from any cause.
Time Frame
2.5 year
Title
PFS by investigator
Description
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
Title
Objective Response Rate (ORR) by investigator
Description
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
Title
Disease Control Rate (DCR) by investigator
Description
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
Title
Objective Response Rate (DOR) by investigator
Description
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
Title
ORR by BIRC
Description
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
Title
DCR by BIRC
Description
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
Title
DOR by BIRC
Description
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
Title
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Description
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Time Frame
2.5 year
Title
Quality Of Life (QoL)
Description
use European Organisation for Research and Treatment of Cance（EORTC）- QLQ-C30 questionnaire
Time Frame
2.5 year
Title
Quality Of Life (QoL)
Description
use EORTC-QLQ-OV28 questionnaire
Time Frame
2.5 year
Title
Serum drug concentrations of BD0801
Description
Serum drug concentrations of BD0801 will be calculated.
Time Frame
2 year
Title
rate of immunogenicity positive reaction
Time Frame
2 year
Title
duration of immunogenicity positive reaction
Time Frame
2 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: non-epithelial tumours ovarian tumours with low malignant potential previous treatment with >2 chemotherapy regimens prior radiotherapy to the pelvis or abdomen within 5 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changhui Sun
Phone
+86-13764281434
Email
sunchanghui@simcere.com
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingying Wu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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