At a glance
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The Effect of Enzastaurin on CYP2C9: Enzastaurin - S-Warfarin Drug Interaction Study in Patients With Cancer
In Brief
A Phase 1 clinical trial evaluating warfarin and enzastaurin for Solid Tumor and Lymphoma, Malignant. Completed, enrolled 13 participants across 7 sites.
Detailed Summary
The purpose of this study is to assess the effect of enzastaurin (LY317615), on a protein (enzyme CYP2C9) which is involved in the metabolic pathway of warfarin in participants with solid tumors or lymphomas. Information about any side effects that may occur will also be collected. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study. This is a Phase 1, open label, fixed sequence, 2 period study conducted in participants with solid tumors or lymphomas. The duration of participation in this study will be up to approximately 38 days not including screening, after which participants will be allowed to continue receiving enzastaurin. There is no planned duration for the extension phase of this study; participants will be allowed to continue to receive enzastaurin until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
Study Details
Timeline
Interventions
Administered orally
Administered orally