Repotrectinib for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, Repotrectinib, to determine its interaction with other common medications in the body. It aims to understand how the body processes Repotrectinib using healthy participants, aiding in predictions of its future use in patients with certain conditions. Individuals who are generally healthy, have no major medical issues, and meet specific physical and health criteria may qualify for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves healthy participants and evaluates drug interactions, it's possible that you may need to pause some medications. Please consult with the trial coordinators for specific guidance.
Is there any evidence suggesting that Repotrectinib is likely to be safe for humans?
Research has shown that repotrectinib has been tested in patients with certain types of lung cancer. In these studies, about 33% of patients experienced serious side effects, and 4.2% had fatal reactions. However, other research suggests that repotrectinib was generally well-tolerated, with most people not experiencing severe issues.
This trial is in the early stages, so information on how well repotrectinib is tolerated for this specific use may be limited. However, since it has been approved for other conditions, some understanding of its safety exists.12345Why do researchers think this study treatment might be promising?
Repotrectinib is unique because it specifically targets TRK, ROS1, and ALK proteins, which are often involved in cancer growth and spread. Unlike traditional treatments like chemotherapy, which can affect healthy cells and cause significant side effects, Repotrectinib aims to more precisely attack cancer cells by inhibiting these specific proteins. This targeted approach may lead to more effective treatment outcomes with potentially fewer side effects, making researchers excited about its potential to improve patient quality of life.
What evidence suggests that Repotrectinib could be effective?
This trial will study repotrectinib in healthy subjects. Research has shown that repotrectinib yields promising results for treating certain cancers. In patients with NTRK-positive solid tumors, it effectively targets tumors in both the body and brain. Studies have also confirmed its long-term effectiveness in patients with ROS1-positive non-small cell lung cancer by improving survival rates. Most patients experience stable or improved quality of life with manageable side effects. Overall, repotrectinib extends survival and maintains quality of life in these cancer conditions.678910
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-60 with a BMI of 18.0 to 32.0 kg/m2. It includes women not able to bear children and men without significant medical deviations as determined by the investigator.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Repotrectinib and probe substrates to evaluate drug-drug interactions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Repotrectinib
Trial Overview
The study tests how Repotrectinib affects the levels of certain drugs in the body, including Metformin, Rosuvastatin, Flurbiprofen, Digoxin, Bupropion, and Omeprazole in healthy participants.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
Efficacy Outcomes of Repotrectinib in Patients with NTRK- ...
The authors concluded that repotrectinib demonstrated durable systemic and intracranial responses with generally low-grade adverse events in ...
2.
cancernursingtoday.com
cancernursingtoday.com/post/trident-1-follow-up-exploring-the-long-term-impact-of-repotrectinib-in-patients-with-ros1-nsclcExploring the Long-Term Impact of Repotrectinib in ...
“With median follow-up of greater than or equal to 42 months, repotrectinib continued to demonstrate durable efficacy in patients with ROS1+ ...
Repotrectinib in NTRK fusion–positive advanced solid tumors
The median overall survival was 18.6 months (95% CI: 11.6–25.3); the estimated 12-month overall survival rate was 62% (95% CI: 50–75) (Extended ...
a promising new therapy for advanced nonsmall cell lung cancer
This study reveals the efficacy of repotrectinib, in regular clinical use with increased survival rates and tolerability outcomes, which significantly advocates ...
PCR158 Patient Reported Outcomes (PRO) From Ongoing ...
Majority of patients reported stable or improved GHS/QOL and treatment-related symptoms. Interim PROs were consistent with top-line efficacy and safety data ...
218213Orig1s000 - accessdata.fda.gov
Integrated safety data to support the use of repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC ...
FDA Approval Summary: Repotrectinib for locally advanced or ...
Serious adverse reactions occurred in 33% of patients who received repotrectinib, with fatal adverse reactions occurring in 4.2%.
NCT06315010 | REPotrectinib in ROS1-positive Non-small ...
REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by ...
Repotrectinib: uses, dosing, warnings, adverse events, ...
Repotrectinib use during pregnancy can cause fetal harm based on data in humans with congenital mutations leading to changes in tropomyosin receptor tyrosine ...
Safety and preliminary clinical activity of repotrectinib in ...
Updated data in 10 additional ROS1. NSCLC and TRK solid tumor pts will be presented. Conclusions: Repotrectinib was well tolerated and demonstrated ...
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