Clinical trial NCT04517357: A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
Official title: A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed Ovarian Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
timeFrame: up to 28 days
measure: (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib
timeFrame: up to 28 days
measure: (Phase 2) Objective response rate（ORR） in relapsed ovarian cancer patients
timeFrame: Assessed up to a maximum of 20 months
measure: (Exploratory research) Objective response rate（ORR） in relapsed ovarian cancer patients
timeFrame: Assessed up to a maximum of 20 months
Secondary outcomes:
measure: AEs+SAEs
timeFrame: from the first drug administration to within 30 days for the last treatment dose
measure: Progression free survival (PFS)
timeFrame: up to 20 months
measure: Disease control rate (DCR)
timeFrame: up to 20 months
measure: Duration of response (DoR)
timeFrame: up to 20 months
measure: Response rate by RECIST 1.1 criteria
timeFrame: up to 20 months
measure: Response rate by GCIG CA125
timeFrame: up to 20 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: