A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients

Eagle Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate

Treatments: Drug: Test Product (Bendamustine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02162888

EGL-BDM-C-1301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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81 participants in 3 patient groups

Eagle-BDM; Teva-BDM; Teva-BDM

Other group

Description:

Eagle-BDM: IV Teva-BDM: IV

Treatment:

Drug: Test Product (Bendamustine)

Teva-BDM; Eagle-BDM;Teva-BDM

Other group

Description:

Eagle-BDM: IV Teva-BDM: IV

Treatment:

Drug: Test Product (Bendamustine)

Teva-BDM, Teva-BDM, Eagle-BDM

Other group

Description:

Eagle-BDM: IV Teva-BDM: IV

Treatment:

Drug: Test Product (Bendamustine)