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RECRUITING
NCT06434610
PHASE2

A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.

Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.

Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-07-11

Completion Date

2026-12-31

Last Updated

2025-01-27

Healthy Volunteers

No

Interventions

DRUG

B013

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.

DRUG

Paclitaxel

Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.

DRUG

Placebo

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.

Locations (17)

Beijing Cancer Hospital

Beijing, China

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

XiangYa Hospital CentralSouth University

Changsha, China

Fujian Cancer Hospital

Fuzhou, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Cancer Hospital of Shandong First Medical University

Jinan, China

Qilu Hospital of Shandong University

Jinan, China

Yunnan Cancer Hospital

Kunming, China

Guangxi Medical University Cancer Hospital

Nanning, China

Fudan University Shanghai Cancer center

Shanghai, China

The Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

The Second Hospital of Hebei Medical University

Shijiazhuang, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Shananxi Provincial Cancer Hospital

Xi'an, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Yibin city second people's Hospital

Yibin, China

Henan Cancer Hospital

Zhengzhou, China