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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162888
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : November 6, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate Drug: Test Product (Bendamustine) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Eagle-BDM; Teva-BDM; Teva-BDM
Eagle-BDM: IV Teva-BDM: IV
Drug: Test Product (Bendamustine)
Teva-BDM; Eagle-BDM;Teva-BDM
Eagle-BDM: IV Teva-BDM: IV
Drug: Test Product (Bendamustine)
Teva-BDM, Teva-BDM, Eagle-BDM
Eagle-BDM: IV Teva-BDM: IV
Drug: Test Product (Bendamustine)



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162888


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

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Responsible Party: Eagle Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02162888    
Other Study ID Numbers: EGL-BDM-C-1301
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents