A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Placebo; Drug: Fluzoparib; Drug: Fluzoparib; Apatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04229615

FZPL-Ⅲ-302

Details and patient eligibility

About

This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Enrollment: 690 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• （phase 3）Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
• （phase 3）Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator
• （phase 3）Ability to be randomized ≤8 weeks after last dose of platinum
• （Saftey Lead-in）Received 2~4 prior chemotherapy regimens. Platimun sensitive relapsed; Have at least one measurable disease as defined by RECIST v1.1.

Exclusion criteria

• Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
• 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).
• 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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690 participants in 3 patient groups, including a placebo group

Safety Lead-in, Doublet Arm

Experimental group

Description:

Fluzoparib+Apatinib

Treatment:

Drug: Fluzoparib; Apatinib

Single Arm

Experimental group

Description:

Fluzoparib

Treatment:

Drug: Fluzoparib

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo