Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate
Conditions
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.
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.
Interventions
DRUGTest Product (Bendamustine)
Sponsors
Eagle Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed