A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Relapsed Ovarian Cancer

Treatments: Drug: Fluzoparib; Drug: Fluzoparib+Apatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04517357

FZPL-II-201

Details and patient eligibility

About

This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
2. Patients must have received at least 2 previous platinum-containing regimens.
3. At least one target lesion.
4. ECOG performance status 0-1.
5. Adequate bone marrow, kidney and liver function.

Exclusion criteria

1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ，patients who received PARP inhibitor are eligible;
2. Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;
3. Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
4. Known to be human immunodeficiency virus positive;
5. Known active hepatitis C virus, or known active hepatitis B virus;
6. Untreated and/or uncontrolled brain metastases;
7. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;
8. Pregnant or breast-feeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Safety Lead-in or Parallel， Fluzoparib+Apatinib

Experimental group

Description:

Participants will receive Fluzoparib-Apatinib combination until progression

Treatment:

Drug: Fluzoparib+Apatinib

Drug: Fluzoparib+Apatinib

Fluzoparib monotherapy

Active Comparator group

Description:

Participants will receive Fluzoparib monotherapy until progression

Treatment:

Drug: Fluzoparib

Exploratory cohort: Fluzoparib+Apatinib

Other group

Description:

Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression

Treatment:

Drug: Fluzoparib+Apatinib

Drug: Fluzoparib+Apatinib