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  • Status : Approved
    • First Submitted Date : 2018/09/11
    • Registered Date : 2019/01/11
    • Last Updated Date : 2018/11/21
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1. Background

Background Information
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 
Address 81, Irwon-ro, Gangnam-gu, Seoul 
Telephone 02-3410-2973 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
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 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 Site Samsung Medical Center 
Recruitment Status Recruiting  
Date of First Enrollment 2018-01-16 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Samsung Medical Center 
Organization Type Medical Institute  
Project ID 2016-02-096 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
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 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
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) * Neoplasms
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 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 /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 Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
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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