Clinical trial NCT02162888: A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate
Lead sponsor: Eagle Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-13
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products
timeFrame: Participants will be in the study for up to 65 days
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Oncology Institute of Hope and Innovation
state: California
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Cherry Hill
country: United States
facility: Regional Cancer Care Associates
state: New Jersey
city: Hershey
country: United States
facility: Penn State University Hershey Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System University Medical Center
state: South Carolina
city: Fort Worth
country: United States
facility: Texas Oncology
state: Texas
city: Temple
country: United States
facility: Scott & White Healthcare
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Spokane
country: United States
facility: Evergreen Hematology & Oncology
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
Study officials:
References:
citation: 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.