A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:11/8/2014
Start Date:November 2013
End Date:December 2014
Contact:Clinical Study Team
Email:mlegiec@eagleus.com

Use our guide to learn which trials are right for you!

The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM)
Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in
patients with cancer.

This is an open-label, randomized, crossover, Phase I study intended to demonstrate the BE,
and safety and tolerability profile of 2 formulations of BDM HCl administered to cancer
patients: Eagle-BDM and Teva-BDM Histologically confirmed diagnosis of any malignant
disease (solid tumors and hematologic malignancies are eligible) for which no curative or
standard therapy is appropriate.

At the end of the study, patients may be enrolled into an open-label extension (OLE) study
(Study EGL-BDM-C-1301-OLE), at the discretion of the investigator.

Inclusion Criteria:

- Histologically confirmed diagnosis of any malignant disease for which no curative or
standard therapy is appropriate.

- Bone Marrow Function and Blood Chemistry results within protocol limits

Exclusion Criteria:

- CLL

- HIV

- Presence of brain metastases
We found this trial at
10
sites
701 Grove Road
Greenville, South Carolina 29605
864-455-7783
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Cherry Hill, New Jersey
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Spokane, Washington 99218
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Temple, Texas 76508
?
mi
from
Temple, TX
Click here to add this to my saved trials
818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Yakima, WA
Click here to add this to my saved trials