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
CRIS Registration Number |
KCT0003422 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
Project ID | 2016-02-096 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) | (C00-D48)Neoplasms |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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. |
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Secondary Outcome(s) 1 | ||
Outcome | disease free survival |
|
Timepoint | It's six months after the last target registration. |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2019. 10 |
Way of Sharing | To be made available at a later date
(joonoh.park@samsung.com) |
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