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

Completed · Phase 1

Conditions studied: Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate

In brief

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.

Key facts

Study ID

NCT02162888

Run by

Eagle Pharmaceuticals, Inc.

People needed

81

Starts

2013-11-01

Expected to finish

2014-11-01

Last updated by the study team

2021-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• CLL
• HIV
• Presence of brain metastases

Where it is running

• Oncology Institute of Hope and Innovation — Long Beach, California, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Regional Cancer Care Associates — Cherry Hill, New Jersey, United States
• Penn State University Hershey Medical Center — Hershey, Pennsylvania, United States
• Greenville Hospital System University Medical Center — Greenville, South Carolina, United States
• Texas Oncology — Fort Worth, Texas, United States
• Scott & White Healthcare — Temple, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Evergreen Hematology & Oncology — Spokane, Washington, United States
• Yakima Valley Memorial Hospital/North Star Lodge — Yakima, Washington, United States

Full record on ClinicalTrials.gov

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