Relapsed Ovarian Cancer
Conditions
Brief summary
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.
Interventions
Fluzoparib-Apatinib combination
DRUGFluzoparib
Fluzoparib monotherapy
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle | up to 28 days | — |
| (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib | up to 28 days | — |
| (Phase 2) Objective response rate（ORR） in relapsed ovarian cancer patients | Assessed up to a maximum of 20 months | Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment |
| (Exploratory research) Objective response rate（ORR） in relapsed ovarian cancer patients | Assessed up to a maximum of 20 months | Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate by RECIST 1.1 criteria | up to 20 months | — |
| AEs+SAEs | from the first drug administration to within 30 days for the last treatment dose | Adverse Events and Serious Adverse Events |
| Response rate by GCIG CA125 | up to 20 months | — |
| Progression free survival (PFS) | up to 20 months | Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment |
| Disease control rate (DCR) | up to 20 months | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1 |
| Duration of response (DoR) | up to 20 months | Time from documentation of tumor response to disease progression assessed among patients who had an objective response |
Countries
China
Outcome results
None listed