Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fluzopanib and bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring PARP inhibitor, Fluzoparib, Bevacizumab, Platinum - sensitive recurrent EOC
Eligibility Criteria
Inclusion Criteria:
- Ovarian cancer patients with histopathological type: low/high grade serous carcinoma, endometrioid carcinoma,had received platinum-based regimens for at least 1-3 lines after primary cytoreductive surgery.
- The patient had at least one measurable lesion according to the RECIST V1.1 criteria.
- The time from the last cycle of chemotherapy to relapse/progression should be more than 6 months.
- ECOG score 0~1,age 18~75 years old
- The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
- CBC Hb≥90g/L, ANC≥1.5×109/L, PLT≥100×109/L,
- Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN#
Exclusion Criteria:
- Had used bevacizumab within 6 months of enrollment
- Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated. The patients had untreated CNS metastases.
- The patient had Recent intestinal obstruction, gastrointestinal perforation within 3 months, uncontrolled high blood pressure after medication (Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg), Moderate to severe cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), moderate to severe deep vein thrombosis and moderate to severe pulmonary embolism occurred within 6 months before enrollment. Patient with coagulation dysfunction.
- Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- Activity or uncontrol severe infection
Sites / Locations
- Chongqing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
maintenance treatment
Arm Description
after 4-9 cycles chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment
Outcomes
Primary Outcome Measures
PFS
progression-free survival was the maintenance time to progression or recurrence since the last platinum therapy based on RECIST v1.1
Secondary Outcome Measures
OS
Overall survival
ORR
Objective Response Rate
DCR
Disease control rate
DoR
Duration of remission
Full Information
NCT ID
NCT05551208
First Posted
August 31, 2022
Last Updated
September 19, 2022
Sponsor
Chongqing University Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05551208
Brief Title
Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi
Official Title
A Prospective, Single-arm, Multicenter Phase Ⅱ Clinical Study of Fluzoparib Combined With Bevacizumab in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing University Cancer Hospital
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
There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Therefore we designed the study to include 42 ovarian cancer patients who had PARPi for at least half a year and then relapsed (platinum-sensitive, previously 1-3 lines of chemotherapy). After getting complete remission or partial remission with chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment. The progression-free survival, ORR, DCR, DoR, and safety were evaluated based on RECIST V1.1.
Detailed Description
Genetic testing of tissue samples before and after the maintenance therapy were also used to further explore the pattern of gene mutations and the subgroups who may benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
PARP inhibitor, Fluzoparib, Bevacizumab, Platinum - sensitive recurrent EOC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
maintenance treatment
Arm Type
Experimental
Arm Description
after 4-9 cycles chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment
Intervention Type
Drug
Intervention Name(s)
fluzopanib and bevacizumab
Intervention Description
fluzopanib and bevacizumab were used for maintenance treatment
Primary Outcome Measure Information:
Title
PFS
Description
progression-free survival was the maintenance time to progression or recurrence since the last platinum therapy based on RECIST v1.1
Time Frame
5 years
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
5 years
Title
ORR
Description
Objective Response Rate
Time Frame
5 years
Title
DCR
Description
Disease control rate
Time Frame
5 years
Title
DoR
Description
Duration of remission
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
saftey
Description
The severity of adverse events was determined according to CTCAE V5.0 criteria. During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ovarian cancer patients with histopathological type: low/high grade serous carcinoma, endometrioid carcinoma,had received platinum-based regimens for at least 1-3 lines after primary cytoreductive surgery.
The patient had at least one measurable lesion according to the RECIST V1.1 criteria.
The time from the last cycle of chemotherapy to relapse/progression should be more than 6 months.
ECOG score 0~1,age 18~75 years old
The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
CBC Hb≥90g/L, ANC≥1.5×109/L, PLT≥100×109/L,
Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN#
Exclusion Criteria:
Had used bevacizumab within 6 months of enrollment
Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated. The patients had untreated CNS metastases.
The patient had Recent intestinal obstruction, gastrointestinal perforation within 3 months, uncontrolled high blood pressure after medication (Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg), Moderate to severe cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), moderate to severe deep vein thrombosis and moderate to severe pulmonary embolism occurred within 6 months before enrollment. Patient with coagulation dysfunction.
Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
Activity or uncontrol severe infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zou Dongling, PH.D.
Phone
+8613657690699
Email
cqzl_zdl@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Zhong, M.D.
Phone
18623393866
Email
zhonglin1983.12.25@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zou Dongling, M.D.
Organizational Affiliation
Chongqing University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zou Dongling, PH.D.
Phone
+8613657690699
Email
cqzl_zdl@163.com
First Name & Middle Initial & Last Name & Degree
Lin Zhong, M.D.
Phone
18623393866
Email
zhonglin1983.12.25@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi
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