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

Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162888
• Other study ID #: EGL-BDM-C-1301
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: June 2021
• Source: Eagle Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Test Product (Bendamustine)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eagle Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cheung EM, Edenfield WJ, Mattar B, Anthony SP, Mutch PJ, Chanas B, Smith M, Hepner A. Safety and Pharmacokinetics of Bendamustine Rapid-Infusion Formulation. J Clin Pharmacol. 2017 Nov;57(11):1400-1408. doi: 10.1002/jcph.942. Epub 2017 May 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products	Each patient will receive 3, single doses of study medication in a 56 day treatment period (2 cycles of 28 days each). Medication will be administered on Cycle 1, Day 1; Cycle 1, Day 2; and Cycle 2, Day 1. Each patient will receive 1 dose of Eagle-BDM and 2 doses of Teva-BDM in 3 randomly assigned, varying treatment sequences(Eagle-BDM, Teva-BDM, Teva-BDM; Teva-BDM, Eagle-BDM, Teva-BDM; or Teva-BDM, Teva-BDM, Eagle-BDM). Pharmacokinetic assessments will be performed.	Participants will be in the study for up to 65 days