A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

June 30, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib in Patients With Recurrent Ovarian Cancer or Triple Negative Breast Cancer

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • Histologically or cytologically confirmed high-grade papillary-serous epithelial ovarian cancer，primary peritoneal, or fallopian tube cancers; subjects with a known deleterious breast cancer gene (BRCA) mutation and any other high-grade histology are also eligible. Subjects should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a > 6 month interval since last receiving platinum therapy prior to disease recurrence. Additionally, subjects with histologically or cytologically confirmed triple negative breast cancer (TNBC）, that is locally advanced or metastatic, are also eligible.
  • Prior therapy：subjects with ovarian cancer，primary peritoneal, or fallopian tube cancers have received only 2 lines of platinum-based chemotherapies, and TNBC patients have received only 1 line of standard chemotherapy. Each prior chemotherapy must be given for at least 2 cycles.
  • At least one measurable lesion that can be accurately assessed by imaging (CT/MRI) at baseline
  • Subjects who have overall good overall general condition.
  • Signed informed consent.

Exclusion Criteria:

  • Subjects who received any previous treatment with any PARP inhibitors.
  • Subjects who received any previous treatment with any VEGFR inhibitors.
  • Less than 4 weeks from the last clinical trial.
  • Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
  • Unstable or uncontrolled hypertension.
  • Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
  • Subjects with brain metastases.
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects with a known hypersensitivity to fluzoparib, apatinib or any of the excipients of the products.
  • Ongoing infection (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Pregnant or breast-feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluzoparib + Apatinib
Fluzoparib and apatinib will be separately administered to patients on the 1st and 4th day, respectively. Then from the 7th day they are administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity.
Drug: Fluzoparib
Fluzoparib either at 40,60,80mg twice daily,capsule oral.
Other Names:
  • SHR3162
  • HS10160
Drug: Apatinib
Apatinib at 250mg once daily, tablet oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The type and incidence of adverse events [safety and tolerability]
Time Frame: From screening up to 28 days after end of treatment
Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v4.03
From screening up to 28 days after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 24 months (approx) from the start of treatment
[Complete response + Partial response (CR+PR)] based on RECIST 1.1
24 months (approx) from the start of treatment
Disease Control Rate (DOR)
Time Frame: 24 months (approx) from the start of treatment
[Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1
24 months (approx) from the start of treatment
Time to Progression (TTP)
Time Frame: From date of enrollment until the date of first objective progression or CA-125 progression (only for ovarian cancer patients), assessed up to 36 months
The time from start of the treatment until radiographic disease progression or CA-125 progression specific for ovarian cancer patients
From date of enrollment until the date of first objective progression or CA-125 progression (only for ovarian cancer patients), assessed up to 36 months
Overall Survival (OS)
Time Frame: From Cycle 1, Day 1 until death or up to 48 months (approx)
Time from start of fluzoparib treatment until death due to any cause
From Cycle 1, Day 1 until death or up to 48 months (approx)
Cmax
Time Frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
Maximum Plasma Concentration
From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
T1/2 (Half-life)
Time Frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
The time required for the plasma concentration of a drug to be reduced by 50%
From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
Area under curve (AUC)
Time Frame: Within the first 5 weeks from start of fluzoparib treatment
Area under the plasma concentration-time curve
Within the first 5 weeks from start of fluzoparib treatment
V/F
Time Frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
Volume of distribution
From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
CL/F
Time Frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
Plasma Clearance
From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborators

Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2017

Primary Completion (Actual)

August 22, 2021

Study Completion (Actual)

December 13, 2021

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FZPL-I-104-OC/BC

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on Fluzoparib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe