CRIZENT: Crizotinib and Sunitinib in Metastatic Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |