Clinical trial NCT04908787: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Xianxiang Medical Technology Co., Ltd.
First posted: 2021-06-01
Enrollment: 421
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Progression free survival(PFS) by blinded independent review committee(BIRC)
timeFrame: 2 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2.5 year
measure: PFS by investigator
timeFrame: 2 year
measure: Objective Response Rate (ORR) by investigator
timeFrame: 2 year
measure: Disease Control Rate (DCR) by investigator
timeFrame: 2 year
measure: Objective Response Rate (DOR) by investigator
timeFrame: 2 year
measure: ORR by BIRC
timeFrame: 2 year
measure: DCR by BIRC
timeFrame: 2 year
measure: DOR by BIRC
timeFrame: 2 year
measure: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 2.5 year
measure: Quality Of Life (QoL)
timeFrame: 2.5 year
measure: Quality Of Life (QoL)
timeFrame: 2.5 year
measure: Serum drug concentrations of BD0801
timeFrame: 2 year
measure: rate of immunogenicity positive reaction
timeFrame: 2 year
measure: duration of immunogenicity positive reaction
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: