Clinical trial · Interventional
A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
NCT02162888CI-TRIAL-00052132completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Test Product (Bendamustine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Eagle-BDM; Teva-BDM; Teva-BDM
- description
- Eagle-BDM: IV Teva-BDM: IV
- interventionNames
- Drug: Test Product (Bendamustine)
- type
- OTHER
- label
- Teva-BDM; Eagle-BDM;Teva-BDM
- description
- Eagle-BDM: IV Teva-BDM: IV
- interventionNames
- Drug: Test Product (Bendamustine)
- type
- OTHER
- label
- Teva-BDM, Teva-BDM, Eagle-BDM
- description
- Eagle-BDM: IV Teva-BDM: IV
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTCheung 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. PMID 28561902