A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
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 |
---|---|---|
|
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
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
- 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
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.- EGL-BDM-C-1301