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 |
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.
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.
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
Greenville, South Carolina 29605
864-455-7783
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
Click here to add this to my saved trials
Click here to add this to my saved trials