drugset / Trial / NCT02129166

Explore the Synergy of Combination TKI Therapy

NCT02129166

Phase 1 Withdrawn University of Florida
RandomizedCrossoverOpen-labelTreatment

Summary

This research study is looking at how imatinib affects how dasatinib is absorbed and eliminated from the body. Both imatinib and dasatinib are in a class of medications called tyrosine kinase inhibitors (TKI) and they are used to treat certain types of leukemia (cancer that begins in the white blood cells). Both imatinib and dasatinib have been given safely in healthy volunteers. In this study investigators will evaluate the pharmacokinetics interaction between imatinib and dasatinib when they are co-administered. The hypothesis is that imatinib will increase the blood levels of dasatinib through inhibiting the drug metabolizing enzyme and efflux transporter that are involved in the dasatinib absorption and removal. This research will provide important new insight of combination TKI therapy in terms of transporter- and enzyme- mediated pharmacokinetic interactions. The research results will also help guide doctors in knowing how much of a tyrosine kinase inhibitor to give safely while reaching best effect in TKI combination therapy.

Timeline

Start
2014-09
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Imatinib Small molecule 400 mg Oral
Comparator dasatinib anhydrous Small molecule 20 mg Oral

Indications

No indication recorded.