RecruitingPhase 2NCT06434610

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

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.


Sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Enrollment

90 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called B013 in combination with paclitaxel (a chemotherapy) for women with ovarian, fallopian tube, or primary peritoneal cancer that has come back after platinum-based chemotherapy and is considered platinum-resistant. **You may be eligible if...** - You have ovarian cancer, fallopian tube cancer, or primary peritoneal cancer confirmed by biopsy - Your cancer meets the criteria for platinum-resistant recurrence (it came back during or shortly after platinum-based chemotherapy) - Your general health is good (ECOG 0–1) and your expected survival is more than 12 weeks - You have at least one measurable tumor lesion - Your major organ functions (blood counts, liver, kidney, heart) are within acceptable ranges - You agree to use reliable contraception if you are of childbearing age **You may NOT be eligible if...** - You have received certain prior treatments excluded by the study protocol - You are currently using anti-tumor traditional Chinese herbal patent medicines - You have active serious infections or other significant health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGB013

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.

DRUGPaclitaxel

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

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06434610


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