Number: 201201055 Principal Investigator: Wang-Gillam, Andrea
Title: An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects with Cancer Who Also Have Impaired Renal Function
Phase: I Disease Site: Multiple Sites
Participating Site(s):
Main Campus
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The purposes of this research study are to determine the effect of kidney damage on the amount of E7389 in your blood and how quickly
the body gets rid of it, to explore how safe E7389 is for subjects with kidney damage, or to see if E7389 causes any decrease in the size of your cancer. Eribulin mesylate (E7389 or Halaven™), the study drug, has been given to more than 2,962 subjects with various types of cancer. E7389 has received approval for metastatic breast in a number of regions
including the European Union, Japan and the USA. E7389 is not approved as a treatment for all cancer patients with impaired renal function, and therefore E7389 is an investigational agent in this study.
More Information: #
Internal Protocol Documents (requires Siteman administrative database password)