An Open Label, Multicenter Phase-2 Study of Single-Agent Enzastaurin HCl in Previously Treaed Waldenstrom's Macroglobulinemia or Multiple Myeloma

Status: COMPLETED
Date: 7/14/2008
Institution: Dana Farber Cancer Institute
Physician: Irene Ghobrial, MD

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that Enzastaurin is still being studied and that research doctors are trying to find out more about it - such as the safest dose to use, the side effects it may cause, and if Enzastaurin is effective for treating different types of cancer. It also means that the FDA (US Food and Drug Administration) has not yet approved Enzastaurin for use in patients, including people with your type of cancer.

The purpose of this research study is to determine how effective and how safe Enzastaurin is for participants with previously treated Waldenstrom's Macroglobulinemia. Enzastaurin is a new type of cancer drug that targets pathways in tumor cells which helps develop their growth. In other trials, Enzastaurin was given safely to over 600 people with different cancer types. In the laboratory, Enzastaurin appeared to stop Waldenstrom's tumor cells from growing.

In this research study, we are studying the efficacy and safety of Enzastaurin and any side effects that might be associated with it, and whether Enzastaurin can help patients with relapsed or refractory Waldenstrom's Macroglobulinemia.

For more information about this clinical trial, please contact Renee LeDuc.