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

Relapsed Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04517357
• Other study ID #: FZPL-II-201
• Status: Recruiting
• Phase: Phase 2
• Start date: October 16, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Quanren Wang
• Phone: +86 18036618570
• Email: quanren.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Relapsed Ovarian Cancer

Intervention

Drug:
• Fluzoparib+Apatinib
Fluzoparib-Apatinib combination
• Fluzoparib
Fluzoparib monotherapy
• Fluzoparib+Apatinib
Fluzoparib-Apatinib combination

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle		up to 28 days
Primary	(Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib		up to 28 days
Primary	(Phase 2) Objective response rate(ORR) in relapsed ovarian cancer patients	Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment	Assessed up to a maximum of 20 months
Primary	(Exploratory research) Objective response rate(ORR) in relapsed ovarian cancer patients	Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment	Assessed up to a maximum of 20 months
Secondary	AEs+SAEs	Adverse Events and Serious Adverse Events	from the first drug administration to within 30 days for the last treatment dose
Secondary	Progression free survival (PFS)	Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment	up to 20 months
Secondary	Disease control rate (DCR)	Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1	up to 20 months
Secondary	Duration of response (DoR)	Time from documentation of tumor response to disease progression assessed among patients who had an objective response	up to 20 months
Secondary	Response rate by RECIST 1.1 criteria		up to 20 months
Secondary	Response rate by GCIG CA125		up to 20 months