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

June 2, 2021 updated by: Eagle Pharmaceuticals, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Eagle-BDM; Teva-BDM; Teva-BDM
Eagle-BDM: IV Teva-BDM: IV
Drug: Test Product (Bendamustine)
OTHER: Teva-BDM; Eagle-BDM;Teva-BDM
Eagle-BDM: IV Teva-BDM: IV
Drug: Test Product (Bendamustine)
OTHER: Teva-BDM, Teva-BDM, Eagle-BDM
Eagle-BDM: IV Teva-BDM: IV
Drug: Test Product (Bendamustine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products
Time Frame: Participants will be in the study for up to 65 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eagle Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (ESTIMATE)

June 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGL-BDM-C-1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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