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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eagle Pharmaceuticals, Inc.
• Treatments: Bendamustine Hydrochloride

Criteria

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