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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eagle-BDM; Teva-BDM; Teva-BDM | Other | Eagle-BDM: IV Teva-BDM: IV |
|
| Teva-BDM; Eagle-BDM;Teva-BDM | Other | Eagle-BDM: IV Teva-BDM: IV |
|
| Teva-BDM, Teva-BDM, Eagle-BDM | Other | Eagle-BDM: IV Teva-BDM: IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Product (Bendamustine) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Hope and Innovation | Long Beach | California | United States | |||
| Cancer Center of Kansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28561902 | Result | 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. |
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| 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 |
| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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