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Clinical trial for the effectiveness and safety evaluation of the plasmaib alone on non-adaptive solid cancer patients

Status Approved

  • First Submitted Date

    2018/09/11

  • Registered Date

    2019/01/11

  • Last Updated Date

    2018/11/21

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
    KCT0003422
    Unique Protocol ID 2016-02-096
    Public/Brief Title Clinical trial for the effectiveness and safety evaluation of the plasmaib alone on non-adaptive solid cancer patients
    Scientific Title Clinical trial for the effectiveness and safety evaluation of the plasmaib alone on non-adaptive solid cancer patients
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted approval
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SMC 2016-02-096-001
    Approval Date 2016-03-30
    Institutional Review Board Name Samsung medical hospital IRB
    Institutional Review Board Address 81, Irwon-ro, Gangnam-gu, Seoul
    Institutional Review Board Telephone 02-3410-2973
    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 JoonOh Park
    Title PI
    Telephone +82-2-3410-3459
    Affiliation Samsung Medical Center
    Address Samsung medical center, 81, Irwon-ro, Gangnam-gu, Seoul
    Contact Person for Public Queries
    Name JoonOh Park
    Title PI
    Telephone +82-2-3410-3459
    Affiliation Samsung Medical Center
    Address Samsung medical center, 81, Irwon-ro, Gangnam-gu, Seoul
    Contact Person for Updating Information
    Name JoonOh Park
    Title PI
    Telephone +82-2-3410-3459
    Affiliation Samsung Medical Center
    Address Samsung medical center, 81, Irwon-ro, Gangnam-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 2018-01-16 Actual
    Target Number of Participant 25
    Primary Completion Date 2019-03-29 , Anticipated
    Study Completion Date 2019-03-29 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Samsung Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2018-01-16 ,
  • 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 Samsung Medical Center
    Organization Type Medical Institute
    Project ID 2016-02-096
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Samsung Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Among the genetic variants associated with cancer, FGFR2 gene amplification is more than an important gene in a number of tumor types, including bile and stomach cancers. In recent years, peppermint has shown increased sensitivity to popanib and, in particular, stomach cancer cell weeks with FGFR2 gene amplification. In the previous phase of marker studies, paparomorphism was shown to inhibit the growth of cancer cells in a variety of cancer cells with FGFR2 amplification, KATO-III, OCUM-2M, SNU-16 and HSC-39. This is expected to allow cancer patients with FGFR2 gene amplification to benefit from the targeted FGFR kinase suppression (Park et al 2014). Wu et al also has 24 primary species with variations of FGFR1, FGFR2, or FGFR3 among other targeted gene fusion. Reports of tumors or cell lines. These FGFR blends involve a number of protein partners with different functions and maintain kinase activity after formation. The identified gene fusion has resulted in FGFR members as 5' or 3' convergence partners with an area of intact kinase, and thus could potentially serve as a viable therapeutic target through kinase suppression.
  • 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 Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Drug  
    Intervention Description
    Through screening, subjects suitable for this clinical trial are registered and the clinical trial drugs are taken as follows: 
    Perform a oral administration of 800 mg once a day. (Daily) continuously take the Pazopanib every 21 days.
    Target recruitment is expected to be 24 months, and the overall study period or the target recruitment period may actually be flexible. 
    The test takers are provided with research medications for three months, and subsequent treatment continues at the patient's own risk.
    Number of Arms 1
    Arm 1

    Arm Label

    Pazopanib

    Target Number of Participant

    25

    Arm Type

    Experimental

    Arm Description

    Through screening, subjects suitable for this clinical trial are registered and the clinical trial drugs are taken as follows: 
    Perform a oral administration of 800 mg once a day. (Daily) continuously take the Pazopanib every 21 days.
    Target recruitment is expected to be 24 months, and the overall study period or the target recruitment period may actually be flexible.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    (C00-D48)Neoplasms 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    1) A patient with the will and ability to sign a clinical trial consent voluntarily and complete all the requirements of a clinical test.
    2) Age over 19
    3) I was previously treated for all kinds of solid cancers that systematically showed FGFR2 gene amplification or gathered special sensitivity to the popanib by avatar scan, but standard treatment.If the law does not exist
    4) ECOG activity is also 0-2
    5) If there is at least one measurable or unmeasurable lesion based on RECIST version 1.1 (this lesion must be evaluated at least 28 days before the start of administration).
    6) Patients with adequate long-term capability defined by the following criteria
    hemodynamic test ANC ≤ 1.5 x 109/L, hemoglobin ≥ 9g/dL, platelet ≥ 100 x 109/L
    Liver function bilirubin ≤ 1.5 x UNL 
    AST/ALT ≤ 2.5 x UNL
    
    7) Adequate contraception is used for men and women in the period of pregnancy, and if there is no pregnancy doctor during the clinical trial (in the case of a fertile woman, pregnancy test is negative).
    8) Appropriate cardiac functions without any clinically significant changes that do not require normal or medical intervention, such as 12-Lead ECG and other symptomal QTc
    Exclusion Criteria
    1) If diagnosed with other types of malignant tumors, other than the following cases (appropriate basal or flat cell skin cancer, or any other disease that has not been treated properly for more than five years)
    2) No history of pre-training or brain transfer (only possible if no symptoms have been treated properly before, and no anticonvulsants or steroids for brain control are currently administered)
    3) Patients with clinically significant gastrointestinal abnormalities that can cause impairment in the use, distribution, or absorption of test drugs, such as those that are not able to administer oral tablets.
    4) If no history of cardiovascular disease is found in the last six months (cardiac arteriosclerosis, cardiac infarction, unstable angioplasty, coronary bypass surgery, symptoms) 2 or more hemolytic heart failure as defined)
    5) Patients who are unable to voluntarily agree to clinical research under the judgment of the researcher due to an unregulated spasm, central nervous system disease or psychiatric disease
    6) A woman on her breast. A nursing woman must stop breastfeeding before the first dose of a test drug and not for 14 days after the end of the dose administration and the last dose of the test drug.
    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
    Capacity-limit toxicity: haematological toxicity and non-hemical toxicity according to Common Terminology Criteria for Adverse Eventsversion 4.0
    Timepoint
    It's six months after the last target registration.
    Secondary Outcome(s) 1
    Outcome
    disease free survival
    Timepoint
    It's six months after the last target registration.
  • 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 Yes
    Time of Sharing 2019. 10
    Way of Sharing To be made available at a later date
    (joonoh.park@samsung.com)
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