Phase
Condition
Adenocarcinoma
Treatment
BR2021
BR2021-1
Clinical Study ID
Ages 19-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Those with histologically or cytologically proven metastatic adenocarcinoma of thepancreas
Those who agree to rule out the possibility of their and their spouses' or sexualpartners' pregnancy by using medically recognized methods of contraception (contraceptives administration & transplantation or intrauterine device(IUD),sterilization(vasectomy, tubal ligation, etc.), barrier methods (spermicide & malecondom, combined use of contraceptive diaphragm, sponge or cervical cap)) from thedate of the first administration of the investigational products to at least 6months after the last administration date and disagree to provide their sperm orovum.
Those who spontaneously decide to participate and sign written consent to complywith the subject's precautions after listening to and fully understanding detailedexplanation of this clinical trial
Exclusion
Exclusion Criteria:
In the case of a female subject, pregnant woman or those suspected pregnancy orlactating woman.
Those who have to administer this study's contraindicated drugs with theinvestigational product from 2 weeks before the participation until end of thisstudy
Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or foodcontaining grapefruit, etc.) that may affect the absorption, distribution,metabolism, and excretion of the drug from 48 hours before the first administrationdate to post study visit(PSV)
Those who can't discontinue other drugs except the investigational product of thisstudy that may affect the metabolism and excretion of the drug for the entire studyperiod (However, if necessary, such as treatment of adverse event, it can beadministrated according to investigator's judgment)
Those who have participated in other clinical trials(including bioequivalence tests)and administered their investigational products within 4 weeks before the firstadministration date (However, the termination for participation in other clinicaltrials are based on the last administration date of their investigational products)or those whose last administration date of their investigational products of otherclinical trials doesn't elapse five times the half-life of their investigationalproducts based on the first administration date of investigational product of thisstudy
Study Design
Connect with a study center
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul,
Korea, Republic ofActive - Recruiting
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