A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
1 other identifier
interventional
81
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2013
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedJune 7, 2021
June 1, 2021
1 year
June 4, 2014
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products
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
Study Arms (3)
Eagle-BDM; Teva-BDM; Teva-BDM
OTHEREagle-BDM: IV Teva-BDM: IV
Teva-BDM; Eagle-BDM;Teva-BDM
OTHEREagle-BDM: IV Teva-BDM: IV
Teva-BDM, Teva-BDM, Eagle-BDM
OTHEREagle-BDM: IV Teva-BDM: IV
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- CLL
- HIV
- Presence of brain metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Oncology Institute of Hope and Innovation
Long Beach, California, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Regional Cancer Care Associates
Cherry Hill, New Jersey, United States
Penn State University Hershey Medical Center
Hershey, Pennsylvania, United States
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States
Texas Oncology
Fort Worth, Texas, 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
Related Publications (1)
Cheung EM, Edenfield WJ, Mattar B, Anthony SP, Mutch PJ, Chanas B, Smith M, Hepner A. Safety and Pharmacokinetics of Bendamustine Rapid-Infusion Formulation. J Clin Pharmacol. 2017 Nov;57(11):1400-1408. doi: 10.1002/jcph.942. Epub 2017 May 31.
PMID: 28561902RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2014
First Posted
June 13, 2014
Study Start
November 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
June 7, 2021
Record last verified: 2021-06