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

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04908787
• Other study ID #: SIM-63-OC-301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 11, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 421
• Est. completion date: December 2024
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• BD0801
Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
• Paclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
• Placebo
Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
• Topotecan
Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
• doxorubicin liposome
Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.	Shanghai Xianxiang Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 year
Secondary	Overall Survival (OS)	OS is the time interval from the date of randomization to death from any cause.	2.5 year
Secondary	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	2 year
Secondary	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	2 year
Secondary	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	2 year
Secondary	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.	2 year
Secondary	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	2 year
Secondary	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	2 year
Secondary	DOR by BIRC	Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.	2 year
Secondary	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	2.5 year
Secondary	Quality Of Life (QoL)	use European Organisation for Research and Treatment of Cance(EORTC)- QLQ-C30 questionnaire	2.5 year
Secondary	Quality Of Life (QoL)	use EORTC-QLQ-OV28 questionnaire	2.5 year
Secondary	Serum drug concentrations of BD0801	Serum drug concentrations of BD0801 will be calculated.	2 year
Secondary	rate of immunogenicity positive reaction		2 year
Secondary	duration of immunogenicity positive reaction		2 year