drugset / Trial / NCT01554371

Eribulin in Combination With Cyclophosphamide in Patients With Solid Tumor Malignancies

NCT01554371

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety of eribulin (Halaven™) and cyclophosphamide (Cytoxan®) given together at different doses. This study will look at what effects, good and/or bad, that these drugs have on solid tumors. Eribulin is a drug that has been approved by the FDA for breast cancer that has spread to other parts of the body. Cyclophosphamide has been approved for different types of cancers (including breast cancer). However, the combination of eribulin and cyclophosphamide is considered experimental; that means this combination has not been approved by the FDA. The funding for this study is provided by Eisai Inc., the maker of eribulin.

Timeline

Start
2012-03-27
Primary completion
2019-12-31
Completion
2019-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Eribulin Small molecule 1.1 mg/m2 Intravenous
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous