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

Phase 1

Completed

• Conditions: Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate
• Interventions: Drug: Test Product (Bendamustine)

• Registration Number: NCT02162888
• Lead Sponsor: Eagle Pharmaceuticals, Inc.

Brief 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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-13
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

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Exclusion Criteria

• CLL
• HIV
• Presence of brain metastases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eagle-BDM; Teva-BDM; Teva-BDM	Test Product (Bendamustine)	Eagle-BDM: IV Teva-BDM: IV
Teva-BDM; Eagle-BDM;Teva-BDM	Test Product (Bendamustine)	Eagle-BDM: IV Teva-BDM: IV
Teva-BDM, Teva-BDM, Eagle-BDM	Test Product (Bendamustine)	Eagle-BDM: IV Teva-BDM: IV

Primary Outcome Measures

Name	Time	Method
To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products	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.

Trial Locations

Locations (10)

Greenville Hospital System University Medical Center; 🇺🇸 Greenville, South Carolina, United States

Cancer Center of Kansas; 🇺🇸 Wichita, Kansas, United States

Regional Cancer Care Associates; 🇺🇸 Cherry Hill, New Jersey, United States

Oncology Institute of Hope and Innovation; 🇺🇸 Long Beach, California, 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

Texas Oncology; 🇺🇸 Fort Worth, Texas, United States

Penn State University Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States