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

Sponsor
Eagle Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02162888
Collaborator
(none)
81
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12
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Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Eagle Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eagle Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02162888
Other Study ID Numbers:
  • EGL-BDM-C-1301
First Posted:
Jun 13, 2014
Last Update Posted:
Jun 7, 2021
Last Verified:
Jun 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2021