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Clinical Trial Summary

This research study is studying a targeted therapy as a possible treatment for cancer abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. The drug involved in this study is: -Abemaciclib


Clinical Trial Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved Abemaciclib as a treatment for any disease. To participate in this study, the participant must have an abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. Abnormalities in these genes may cause the cancer to grow more rapidly. CDK4 and CDK6 are proteins that are involved with the cell growth process. D-type cyclins (CCND1, CCND2, and CCND3) are proteins that help control the activity of CDK4 and CDK6. Abemaciclib is being studied as a treatment for people with advanced cancer. Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth. In this research study, the investigators are hoping to learn whether Abemaciclib can be used to slow or stop the growth of cancers with specific genetic abnormalities. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03310879
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Geoffrey Shapiro, MD, PhD
Phone 617-632-4942
Email geoffrey_shapiro@dfci.harvard.edu
Status Recruiting
Phase Phase 2
Start date November 21, 2017
Completion date April 30, 2025

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