Comparing two treatments for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to compare the pharmacokinetic characteristics and safety of two investigational treatments, BR2021 and BR2021-1, in patients diagnosed with metastatic adenocarcinoma of the pancreas. Participants will receive either treatment and undergo monitoring to evaluate how the drugs are processed in the body and their safety profiles. The study is designed to provide insights into which treatment may be more effective or safer for patients with this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Those with histologically or cytologically proven metastatic adenocarcinoma of the pancreas
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically recognized methods of contraception (contraceptives administration \& transplantation or intrauterine device(IUD), sterilization(vasectomy, tubal ligation, etc.), barrier methods (spermicide \& male condom, combined use of contraceptive diaphragm, sponge or cervical cap)) from the date of the first administration of the investigational products to at least 6 months after the last administration date and disagree to provide their sperm or ovum.
* Those who spontaneously decide to participate and sign written consent to comply with the subject's precautions after listening to and fully understanding detailed explanation of this clinical trial

Exclusion Criteria:

* In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
* Those who have to administer this study's contraindicated drugs with the investigational product from 2 weeks before the participation until end of this study
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug from 48 hours before the first administration date to post study visit(PSV)
* Those who can't discontinue other drugs except the investigational product of this study that may affect the metabolism and excretion of the drug for the entire study period (However, if necessary, such as treatment of adverse event, it can be administrated 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 first administration date (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products) or those whose last administration date of their investigational products of other clinical trials doesn't elapse five times the half-life of their investigational products based on the first administration date of investigational product of this study

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting
• The Catholic University of Korea Seoul St. Mary's Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Shin-young Oh
• Email: syoh@boryung.co.kr
• Phone: +82-2-708-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.