Comparing two treatments for pancreatic cancer
A Multi-center, Open-label, Randomized, Two-stage, Two-way Crossover Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1 in Patients With Metastatic Adenocarcinoma of the Pancreas
This study is testing two new treatments for pancreatic cancer to see which one is safer and works better for patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 19 Years to 74 Years |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06867497 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who can comply with the study's contraceptive requirements.
Not a fit: Patients who are pregnant, lactating, or have a suspected pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with metastatic pancreatic cancer.
How similar studies have performed: While this specific comparison may be novel, similar pharmacokinetic studies in cancer treatments have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.