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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Eagle-BDM; Teva-BDM; Teva-BDM

Eagle-BDM: IV Teva-BDM: IV

Group Type OTHER

Test Product (Bendamustine)

Intervention Type DRUG

Teva-BDM; Eagle-BDM;Teva-BDM

Eagle-BDM: IV Teva-BDM: IV

Group Type OTHER

Test Product (Bendamustine)

Intervention Type DRUG

Teva-BDM, Teva-BDM, Eagle-BDM

Eagle-BDM: IV Teva-BDM: IV

Group Type OTHER

Test Product (Bendamustine)

Intervention Type DRUG

Interventions

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Test Product (Bendamustine)

Intervention Type DRUG

Eligibility Criteria

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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