To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Beijing Cancer Hospital
Beijing, China
RECRUITINGThe First Affiliated Hospital of Bengbu Medical University
Progression-free survival (PFS)
From the date of randomization to the date of progression disease or death , whichever occurred first.
Time frame: Approximately 2 years
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Time frame: Approximately 2 years
Disease control rate (DCR)
DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.
Time frame: Approximately 2 years
Duration of remission (DOR)
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
Time frame: Approximately 5 years
Overall Survival (OS)
Determination of the overall survival times of all participants.
Time frame: Approximately 2 years
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
The incidence of adverse event (regardless of its relationship to study drug) will be classified using MedDRA and the severity of each adverse event will be graded using NCI CTCAE v5.0.
Time frame: Approximately 5 years
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Bengbu, China
XiangYa Hospital CentralSouth University
Changsha, China
RECRUITINGFujian Cancer Hospital
Fuzhou, China
RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
RECRUITINGCancer Hospital of Shandong First Medical University
Jinan, China
RECRUITINGQilu Hospital of Shandong University
Jinan, China
RECRUITINGYunnan Cancer Hospital
Kunming, China
RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, China
RECRUITINGFudan University Shanghai Cancer center
Shanghai, China
RECRUITING...and 7 more locations