Overview

A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients

Status:
Active, not recruiting
Trial end date:
2022-03-31
Target enrollment:
0
Participant gender:
Female
Summary
To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Criteria
Inclusion Criteria:

1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including
primary peritoneal and fallopian tube cancer)

2. Completion of ≥2 previous platinum-containing regimens

3. Complete response (CR) or partial response (PR) achieved with last platinum-based
chemotherapy regimen as determined by investigator

4. Ability to be randomized ≤8 weeks after last dose of platinum

Exclusion Criteria:

1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor

2. Patients who have received other study drug treatment within 4 weeks prior to the
first administration(< 5 elimination half-lives of the study drug molecular targeted
anti-cancer drugs).

3. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to
drainage, or who have undergone ascites drainage within 2 months prior to the first
administration.