KCT0003422Recruiting未知
Clinical trial for the effectiveness and safety evaluation of the plasmaib alone on non-adaptive solid cancer patients
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Samsung Medical Center
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •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.
Investigators
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