drugset / Trial / NCT02074878

CRIZENT: Crizotinib and Sunitinib in Metastatic Breast Cancer

NCT02074878

Phase 1 Terminated 3 enrolled Mothaffar Rimawi
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase 1 Trial. Crizotinib is a medication that is taken by mouth. It has shown that it can help slow down or stop the growth of tumor cells. The marketing name of the drug is "Xalkori". It has been approved by the FDA (Food and Drug Administration) to treat other types of metastatic cancer, but the investigators believe it may be helpful to treat breast cancer as well. Sunitinib is the other medication used in the study. It is also taken by mouth in the form of a capsule. The marketing name of this drug is "Sutent". It too has been approved by the FDA to treat other types of cancer, but not for breast cancer. In this study the investigators will be combining both of these two treatments, but at different doses. One third of the patients will take Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg once a day. One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg once a day, and One third of the patients will take Crizotinib 250 mg, twice daily with Sunitinib 37.5 mg once a day.

Timeline

Start
2014-06
Primary completion
2017-05-16
Completion
2017-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Crizotinib Small molecule 200 mg Oral
Subject Crizotinib Small molecule 250 mg Oral
Subject Sunitinib Small molecule 25 mg Oral
Subject Sunitinib Small molecule 37.5 mg Oral

Indications