A Study of Bevacizumab Combined With Fluzoparib/Chemotherapy or Fluzoparib in the Treatment of Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bevacizumab
chemotherapy
Fluzoparib
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring platinum-resistant, recurrent ovarian cancer, Bevacizumab, Fluzoparib
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years, female;
- Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology;
- ECOG score was 0-1;
- Expected survival time > 12 weeks;
- Normal or abnormal bone marrow, kidney, and liver function of the patient has no clinical significance, and the specific situation will be comprehensively determined by the investigator;
- Patients not previously treated with PARPi or targeted drugs;
- The patient has taken effective contraceptive measures within 14 days prior to screening and is willing to sign the notification until the last medication No pregnancy plan and voluntary use of effective contraceptive measures within the next 6 months;
- The subject or his/her legal guardian can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the informed consent.
Exclusion Criteria:
- Known allergy to fluzopalil or study drug components;
- Patients with any factors affecting oral administration (such as previous gastric or small bowel resection, or current atrophic gastritis, chronic intestinal disease, gastrointestinal bleeding, dysphagia, gastrointestinal obstruction, or diarrhea greater than grade 1, including those who have recovered but have not recovered);
- Patients who underwent major surgery or gastrointestinal surgery affecting drug absorption, open biopsy, severe traumatic injury, wound unhealed or did not recover from major surgery within 1 month before the trial;
- Before the first administration, patients have used strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or medium CYP3A inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil, etc.); Patients who had used strong CYP3A inducers (e.g., phenobarbide, enzyluamide, phenytoin, rifampicin, rifambutin, rifapentine, carbamazepine, nevirapine and St. John's herb) or medium CYP3A inducers (e.g., Bosentan, efavirenz, modafinil, etc.) and did not reach 3 elimination half-lives;
- Pregnant or lactating women or subjects who cannot use contraception as required;
- Those who have special requirements on diet and cannot accept uniform diet;
- As judged by the researcher, there are other circumstances that are not suitable for the researcher.
Sites / Locations
- The Second Affiliated Hospital of Shandong First Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Bevacizumab combined with Fluzoparib
Bevacizumab combined with chemotherapy
Fluzoparib
Arm Description
Bevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer.
Bevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
Fluzoparib monotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
Outcomes
Primary Outcome Measures
Progression-Free-Survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Secondary Outcome Measures
Objective remission rate
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR).
Overall Survival
Time from randomization to death from any cause (for subjects who have been lost to follow-up prior to death, the time of death is usually calculated as the time of last follow-up)
Adverse event Adverse event
It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug
Full Information
NCT ID
NCT05170594
First Posted
December 24, 2021
Last Updated
December 24, 2021
Sponsor
The Second Affiliated Hospital of Shandong First Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05170594
Brief Title
A Study of Bevacizumab Combined With Fluzoparib/Chemotherapy or Fluzoparib in the Treatment of Ovarian Cancer
Official Title
A Prospective Study of Bevacizumab Combined With Fluzoparib, Bevacizumab Combined With Chemotherapy or Fluzoparib Monotherapy in the Treatment of Platinum-resistant Recurrent Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Shandong First Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to explore the safety and efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.
Detailed Description
This purpose of this study is to explore efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.Besides the efficacy,we focus on the safety and quality of life in the new treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
platinum-resistant, recurrent ovarian cancer, Bevacizumab, Fluzoparib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab combined with Fluzoparib
Arm Type
Experimental
Arm Description
Bevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer.
Arm Title
Bevacizumab combined with chemotherapy
Arm Type
Experimental
Arm Description
Bevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
Arm Title
Fluzoparib
Arm Type
Experimental
Arm Description
Fluzoparib monotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Antiangiogenic drugs
Intervention Description
Bevacizumab will be administered at 15mg/kg IV, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Other Intervention Name(s)
Non-platinum chemotherapy
Intervention Description
The non-platinum chemotherapy regimen will be determined by the investigator.
Intervention Type
Drug
Intervention Name(s)
Fluzoparib
Other Intervention Name(s)
PARPi
Intervention Description
Fluzoparib will be administered orally continuously at 150mg bid until disease progression and toxicity becomes intolerable
Primary Outcome Measure Information:
Title
Progression-Free-Survival
Description
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective remission rate
Description
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR).
Time Frame
2 years
Title
Overall Survival
Description
Time from randomization to death from any cause (for subjects who have been lost to follow-up prior to death, the time of death is usually calculated as the time of last follow-up)
Time Frame
2 years
Title
Adverse event Adverse event
Description
It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug
Time Frame
2 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:
Age ≥18 years, female;
Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology;
ECOG score was 0-1;
Expected survival time > 12 weeks;
Normal or abnormal bone marrow, kidney, and liver function of the patient has no clinical significance, and the specific situation will be comprehensively determined by the investigator;
Patients not previously treated with PARPi or targeted drugs;
The patient has taken effective contraceptive measures within 14 days prior to screening and is willing to sign the notification until the last medication No pregnancy plan and voluntary use of effective contraceptive measures within the next 6 months;
The subject or his/her legal guardian can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the informed consent.
Exclusion Criteria:
Known allergy to fluzopalil or study drug components;
Patients with any factors affecting oral administration (such as previous gastric or small bowel resection, or current atrophic gastritis, chronic intestinal disease, gastrointestinal bleeding, dysphagia, gastrointestinal obstruction, or diarrhea greater than grade 1, including those who have recovered but have not recovered);
Patients who underwent major surgery or gastrointestinal surgery affecting drug absorption, open biopsy, severe traumatic injury, wound unhealed or did not recover from major surgery within 1 month before the trial;
Before the first administration, patients have used strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or medium CYP3A inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil, etc.); Patients who had used strong CYP3A inducers (e.g., phenobarbide, enzyluamide, phenytoin, rifampicin, rifambutin, rifapentine, carbamazepine, nevirapine and St. John's herb) or medium CYP3A inducers (e.g., Bosentan, efavirenz, modafinil, etc.) and did not reach 3 elimination half-lives;
Pregnant or lactating women or subjects who cannot use contraception as required;
Those who have special requirements on diet and cannot accept uniform diet;
As judged by the researcher, there are other circumstances that are not suitable for the researcher.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Miao
Phone
+86-13854893531
Email
miaoyue0626@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiyan Liu
Organizational Affiliation
The Second Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Shandong First Medical University
City
Tai'an
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhensheng Fang
Phone
+86-0538-6236830
Email
sdtatszhenhua@126.com
First Name & Middle Initial & Last Name & Degree
Haiyan Liu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26723501
Citation
Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmana J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Loman N, Robertson JD, Mann H, Kaufman B. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol. 2016 Feb;140(2):199-203. doi: 10.1016/j.ygyno.2015.12.020. Epub 2015 Dec 23.
Results Reference
background
PubMed Identifier
30948273
Citation
Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, Wahner Hendrickson AE, Azodi M, DiSilvestro P, Oza AM, Cristea M, Berek JS, Chan JK, Rimel BJ, Matei DE, Li Y, Sun K, Luptakova K, Matulonis UA, Monk BJ. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1. Erratum In: Lancet Oncol. 2019 May;20(5):e242.
Results Reference
background
PubMed Identifier
34711457
Citation
Mellinghoff IK, Chang SM, Jaeckle KA, van den Bent M. Isocitrate Dehydrogenase Mutant Grade II and III Glial Neoplasms. Hematol Oncol Clin North Am. 2022 Feb;36(1):95-111. doi: 10.1016/j.hoc.2021.08.008. Epub 2021 Oct 25.
Results Reference
background
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A Study of Bevacizumab Combined With Fluzoparib/Chemotherapy or Fluzoparib in the Treatment of Ovarian Cancer
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