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Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment

Primary Purpose

Relapsed Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fluzoparib
Apatinib
Sponsored by
Jin Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient voluntarily joined the study and signed the informed consent. Age 18-75 years old. Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma. Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR was achieved, and the time from the penultimate platinum containing chemotherapy to PD was ≥ 6 months. Patients who have received previous treatment with bevacizumab are acceptable. Allow previous treatment with PARP inhibitors other than Fluzoparib. ECOG score: 0-1. Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted) Absolute neutrophil count (ANC) ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥10g/dL Serum albumin ≥3g/dL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during he study treatment period and within 2 months after the last administration of apatinib or 6 months after the last administration of fluzopril, whichever is longer; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period. Exclusion Criteria: Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and breast cancer with no recurrence >3 years after radical surgery. The subject has untreated central nervous system metastasis. Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect drug absorption according to the researchers. Recent (within 3 months) occurrence of intestinal obstruction. Patients with clinical symptoms of cancerous ascites and pleural effusion, who need puncture or drainage, or who have received ascites and pleural effusion drainage within 2 months before the first trial medication. Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc>470ms. Those with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), who have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy, are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial. The subject has an active infection or unexplained fever >38.5 degrees during the screening period and before the first dose; Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml; Hepatitis C reference: HCV antibody positive and HCV copy number > upper limit of normal). Those who had previously received radiotherapy, chemotherapy, endocrine therapy, or molecular targeted therapy and were enrolled less than 4 weeks after the completion of treatment (last dose); Adverse events (except alopecia) caused by previous treatment did not recover to ≤1 degree (CTCAE 5.0). Patients who have used other drugs in clinical trial studies within the previous 4 weeks. Subjects may receive other systemic anti-tumor therapies during the study period. known allergy to Fluzoparib, apatinib and its excipients. In the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subjects, or the collection of data and samples.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Fluzoparib+Apatinib combination

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression Free Survival(PFS)
    To determine the efficacy by progression free survival (PFS) of the maintenance treatment in previous PARP inhibitor treated platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined).

    Secondary Outcome Measures

    Objective Response Rate (ORR)
    Disease Control Rate (DCR)
    Overall survival (OS)
    Adverse Events (AEs)
    Assese the safety and tolerability of Fluzoparib combined with apatinib maintenance in platinum sensitive relapsed ovarian cancer patients by record the number of participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.

    Full Information

    First Posted
    October 7, 2023
    Last Updated
    October 7, 2023
    Sponsor
    Jin Li
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06081595
    Brief Title
    Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment
    Official Title
    Fluzoparib Combined With Apatinib for Maintenance Treatment in Platinum-Sensitive Relapsed Ovarian Carcinoma: A Phase II Single-arm, Open Label, Multicenter Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jin Li

    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 is a Phase II single-arm, open label, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma .

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluzoparib+Apatinib combination
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Fluzoparib
    Intervention Description
    Fluzoparib 100mg bid
    Intervention Type
    Drug
    Intervention Name(s)
    Apatinib
    Intervention Description
    Apatinib 375mg qd
    Primary Outcome Measure Information:
    Title
    Progression Free Survival(PFS)
    Description
    To determine the efficacy by progression free survival (PFS) of the maintenance treatment in previous PARP inhibitor treated platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined).
    Time Frame
    Up to 2 years
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate (ORR)
    Time Frame
    Up to 2 years
    Title
    Disease Control Rate (DCR)
    Time Frame
    Up to 2 years
    Title
    Overall survival (OS)
    Time Frame
    Up to 2 years
    Title
    Adverse Events (AEs)
    Description
    Assese the safety and tolerability of Fluzoparib combined with apatinib maintenance in platinum sensitive relapsed ovarian cancer patients by record the number of participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.
    Time Frame
    From the first drug administration to within 30 days for the last treatment dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient voluntarily joined the study and signed the informed consent. Age 18-75 years old. Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma. Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR was achieved, and the time from the penultimate platinum containing chemotherapy to PD was ≥ 6 months. Patients who have received previous treatment with bevacizumab are acceptable. Allow previous treatment with PARP inhibitors other than Fluzoparib. ECOG score: 0-1. Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted) Absolute neutrophil count (ANC) ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥10g/dL Serum albumin ≥3g/dL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during he study treatment period and within 2 months after the last administration of apatinib or 6 months after the last administration of fluzopril, whichever is longer; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period. Exclusion Criteria: Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and breast cancer with no recurrence >3 years after radical surgery. The subject has untreated central nervous system metastasis. Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect drug absorption according to the researchers. Recent (within 3 months) occurrence of intestinal obstruction. Patients with clinical symptoms of cancerous ascites and pleural effusion, who need puncture or drainage, or who have received ascites and pleural effusion drainage within 2 months before the first trial medication. Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc>470ms. Those with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), who have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy, are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial. The subject has an active infection or unexplained fever >38.5 degrees during the screening period and before the first dose; Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml; Hepatitis C reference: HCV antibody positive and HCV copy number > upper limit of normal). Those who had previously received radiotherapy, chemotherapy, endocrine therapy, or molecular targeted therapy and were enrolled less than 4 weeks after the completion of treatment (last dose); Adverse events (except alopecia) caused by previous treatment did not recover to ≤1 degree (CTCAE 5.0). Patients who have used other drugs in clinical trial studies within the previous 4 weeks. Subjects may receive other systemic anti-tumor therapies during the study period. known allergy to Fluzoparib, apatinib and its excipients. In the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subjects, or the collection of data and samples.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data is available per require after approved by ethics broad

    Learn more about this trial

    Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment

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