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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Placebo capsules; Drug: Fluzoparib capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT03863860

FZPL-Ⅲ-301-OC

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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252 participants in 2 patient groups, including a placebo group

Fluzoparib capsules, 50mg per capsule

Experimental group

Description:

Fluzoparib capsules, PO

Treatment:

Drug: Fluzoparib capsules

Placebo capsules, 50mg per capsule

Placebo Comparator group

Description:

Placebo capsules, PO

Treatment:

Drug: Placebo capsules