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A single-arm phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor

Status Approved

  • First Submitted Date

    2021/03/24

  • Registered Date

    2021/04/05

  • Last Updated Date

    2021/07/06

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006051
    Unique Protocol ID 4-2021-0076
    Public/Brief Title A single-arm phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor
    Scientific Title A single-arm phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT04734665
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 4-2021-0076
    Approval Date 2021-03-17
    Institutional Review Board Name Yonsei University Health system, Severance Hospital, Institutional Review Board
    Institutional Review Board Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Institutional Review Board Telephone 02-2228-0435
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jungyun Lee
    Title Professor
    Telephone +82-2-2228-2237
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Public Queries
    Name Yunjung Go
    Title Clinical Research Co
    Telephone +82-2-2228-0570
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Updating Information
    Name Hyeyoon Lee
    Title Clinical Research Co
    Telephone +82-2-2228-0554
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-07-05 Actual
    Target Number of Participant 44
    Primary Completion Date 2024-03-16 , Anticipated
    Study Completion Date 2024-03-16 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-07-05 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Takeda
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University Health System, Severance Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    -Primary Aim/Objective : To determine the efficacy of niraparib re-treatment with bevacizumab by assessment of Progression-free survival (PFS)
    - Hypothesis : Niraparib re-treatment with Bevacizumab is synergistic in patients previously treated with a PARP inhibitor
    - Treatment : 
       niraparib po 200mg or 300mg QD*
       bevacizumab iv15mg/kg  every 3 weeks (Q3W)
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase2
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type Drug  
    Intervention Description
    If the subject has enrolled, the drugs will be administered until PD as below.
     - niraparib po 200mg or 300mg QD*
     - bevacizumab iv15mg/kg  every 3 weeks (Q3W)
    Number of Arms 1
    Arm 1

    Arm Label

    Experimental

    Target Number of Participant

    44

    Arm Type

    Experimental

    Arm Description

    If the subject has enrolled, the drugs will be administered until PD as below.
     - niraparib po 200mg or 300mg QD*
     - bevacizumab iv15mg/kg  every 3 weeks (Q3W)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C56.9)Malignant neoplasm of ovary, unspecified side 

    Ovarian cancer
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~No Limit

    Description

    1) Participant has histologically confirmed diagnosis of high-grade predominantly serous, endometrioid, carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC, primary peritoneal cancer, or fallopian tube cancer will be enrolled in this study (only up to 4 patients with clear cell carcinoma will be included and mucinous carcinoma will not be included).
    2) Participant has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 12 months’ period between penultimate platinum regimen and progression of disease)
    Note: The last platinum regimen does not necessarily have to immediately follow the next to last (penultimate) platinum regimen. For example, if a patient received a non-platinum regimen between the penultimate platinum regimen and last platinum regimen, they could be eligible, so long as they meet all entry criteria. 
    3) Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
    4) Participant had prior treatment with PARP inhibitor
    5) Participant is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA 1/2 and PD-L1 status prior to enrollment.
    6) Female participants who are at least 20 years of age on the day of signing informed consent with.
    7) Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment.
    8) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 
    a.) Not a woman of childbearing potential (WOCBP) OR 
    b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days following the last dose of niraparib and at least 210 days following the last dose of chemotherapy or bevacizumab
    9) The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.  The participant may also provide consent for future biomedical research; however, the participant may participate in the main study without participating in future biomedical research.
    10) Participant has adequate organ function as defined in the following table (Table 1).; all screening laboratory tests should be performed within 10 days prior to the start of study treatment
    Table 1  Adequate Organ Function Laboratory Values
    System Laboratory Value
    Hematological 
    Absolute neutrophil count (ANC) ≥1500/µL
    Platelets ≥100 000/µL
    Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La
    Renal 
    Creatinine OR
    Measured or calculatedb creatinine clearance
    (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR
    ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
    Hepatic 
    Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
    AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
    Coagulation 
    International normalized ratio (INR) OR prothrombin time (PT)
    Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
    ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.
    a Criteria must be met without erythropoietin dependency. 
    b Creatinine clearance (CrCl) should be calculated per institutional standard.
    Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.
    Exclusion Criteria
    1) Participant has mucinous, germ cell, or borderline tumor of the ovary.
    2) Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis.
    3) Participant either has myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or has features suggestive of MDS/AML.
    4) Participant has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
    Note:  Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, endometrial carcinoma) that have undergone potentially curative therapy are not excluded.
    Note: Participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than IA: no more than superficial myometrial invasion
    5) Drainage of ascites during last 2 cycles of last chemotherapy.
    6) Palliative radiotherapy within 1 week encompassing >20% of the bone marrow.
    7) Persistent > grade 2 toxicity from prior cancer therapy.
    8) Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days.
    9) Known hypersensitivity to the components of niraparib.
    10) Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery.
    11) Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non- malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
    12) History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient‘s participation for the full duration of the study treatment, or is not in the best interest of the patient to participate.
    13) Immunocompromised patients
    14) Patients with known active hepatic disease (i.e. , Hepatitis B or C).
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    progression-free survival
    Timepoint
    6months
    Secondary Outcome(s) 1
    Outcome
    Overall survival (OS)
    Timepoint
    Up to 1year
    Secondary Outcome(s) 2
    Outcome
    Time to tumour progression (TTP)
    Timepoint
    Up to 1year
    Secondary Outcome(s) 3
    Outcome
    Time to first subsequent treatment(or death)
    Timepoint
    The date of first documented first subsequent treatment or date of death, assessed up to 72 months
    Secondary Outcome(s) 4
    Outcome
    Time to second subsequent treatment
    Timepoint
    The date of first documented second subsequent treatment assessed up to 72 months
    Secondary Outcome(s) 5
    Outcome
    progression-free survival
    Timepoint
    Up to 1year
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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