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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed Ovarian Cancer
• Intervention / Treatment: Drug: Fluzoparib+Apatinib; Drug: Fluzoparib

• Study Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Quanren Wang; Phone Number: +86 18036618570; Email: quanren.wang@hengrui.com
• Study Contact Backup: Name: Li bo; Phone Number: +86 13124759639; Email: bo.li@hengrui.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Jianqing Zhu; Phone Number: 0571-88122222; Email: zjq-hz@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Lead-in or Parallel， Fluzoparib+Apatinib; Participants will receive Fluzoparib-Apatinib combination until progression	Drug: Fluzoparib+Apatinib; Fluzoparib-Apatinib combination
Active Comparator: Fluzoparib monotherapy; Participants will receive Fluzoparib monotherapy until progression	Drug: Fluzoparib; Fluzoparib monotherapy
Other: Exploratory cohort: Fluzoparib+Apatinib; Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression	Drug: Fluzoparib+Apatinib; Fluzoparib-Apatinib combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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	Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment	Assessed up to a maximum of 20 months
(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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs+SAEs	Adverse Events and Serious Adverse Events	from the first drug administration to within 30 days for the last treatment dose
Progression free survival (PFS)	Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment	up to 20 months
Disease control rate (DCR)	Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1	up to 20 months
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
Response rate by RECIST 1.1 criteria		up to 20 months
Response rate by GCIG CA125		up to 20 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 16, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: FZPL-II-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No