A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
Primary Purpose
Relapsed Ovarian Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluzoparib+Apatinib
Fluzoparib
Fluzoparib+Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
- Patients must have received at least 2 previous platinum-containing regimens.
- At least one target lesion.
- ECOG performance status 0-1.
- Adequate bone marrow, kidney and liver function.
Exclusion Criteria:
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ,patients who received PARP inhibitor are eligible;
- 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;
- Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
- Known to be human immunodeficiency virus positive;
- Known active hepatitis C virus, or known active hepatitis B virus;
- Untreated and/or uncontrolled brain metastases;
- 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;
- Pregnant or breast-feeding women.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Safety Lead-in or Parallel, Fluzoparib+Apatinib
Fluzoparib monotherapy
Exploratory cohort: Fluzoparib+Apatinib
Arm Description
Participants will receive Fluzoparib-Apatinib combination until progression
Participants will receive Fluzoparib monotherapy until progression
Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression
Outcomes
Primary Outcome Measures
(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
(Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib
(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
(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
Secondary Outcome Measures
AEs+SAEs
Adverse Events and Serious Adverse Events
Progression free survival (PFS)
Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Response rate by RECIST 1.1 criteria
Response rate by GCIG CA125
Full Information
NCT ID
NCT04517357
First Posted
August 16, 2020
Last Updated
October 25, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04517357
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Safety Lead-in or Parallel, Fluzoparib+Apatinib
Arm Type
Experimental
Arm Description
Participants will receive Fluzoparib-Apatinib combination until progression
Arm Title
Fluzoparib monotherapy
Arm Type
Active Comparator
Arm Description
Participants will receive Fluzoparib monotherapy until progression
Arm Title
Exploratory cohort: Fluzoparib+Apatinib
Arm Type
Other
Arm Description
Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression
Intervention Type
Drug
Intervention Name(s)
Fluzoparib+Apatinib
Intervention Description
Fluzoparib-Apatinib combination
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Intervention Description
Fluzoparib monotherapy
Intervention Type
Drug
Intervention Name(s)
Fluzoparib+Apatinib
Intervention Description
Fluzoparib-Apatinib combination
Primary Outcome Measure Information:
Title
(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
Time Frame
up to 28 days
Title
(Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib
Time Frame
up to 28 days
Title
(Phase 2) Objective response rate(ORR) in relapsed ovarian cancer patients
Description
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Time Frame
Assessed up to a maximum of 20 months
Title
(Exploratory research) Objective response rate(ORR) in relapsed ovarian cancer patients
Description
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Time Frame
Assessed up to a maximum of 20 months
Secondary Outcome Measure Information:
Title
AEs+SAEs
Description
Adverse Events and Serious Adverse Events
Time Frame
from the first drug administration to within 30 days for the last treatment dose
Title
Progression free survival (PFS)
Description
Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment
Time Frame
up to 20 months
Title
Disease control rate (DCR)
Description
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Time Frame
up to 20 months
Title
Duration of response (DoR)
Description
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Time Frame
up to 20 months
Title
Response rate by RECIST 1.1 criteria
Time Frame
up to 20 months
Title
Response rate by GCIG CA125
Time Frame
up to 20 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
Patients must have received at least 2 previous platinum-containing regimens.
At least one target lesion.
ECOG performance status 0-1.
Adequate bone marrow, kidney and liver function.
Exclusion Criteria:
Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ,patients who received PARP inhibitor are eligible;
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;
Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
Known to be human immunodeficiency virus positive;
Known active hepatitis C virus, or known active hepatitis B virus;
Untreated and/or uncontrolled brain metastases;
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;
Pregnant or breast-feeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanren Wang
Phone
+86 18036618570
Email
quanren.wang@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li bo
Phone
+86 13124759639
Email
bo.li@hengrui.com
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianqing Zhu
Phone
0571-88122222
Email
zjq-hz@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
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