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NCT02162888 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
A Phase 1 study, sponsored by Eagle Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT02162888: Completed Phase 1 study, sponsored by Eagle Pharmaceuticals.
NCT02162888 is a Phase 1 study that has completed, run by Eagle Pharmaceuticals. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02162888, a Phase 1 study, has completed, sponsored by Eagle Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Test Product (Bendamustine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT02162888 record still lists
NCT02162888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which Test Product (Bendamustine) is the first listed.
NCT02162888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02162888 about?
NCT02162888 is a clinical study titled "A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients". 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.
What is the current status of trial NCT02162888?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2013-11. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02162888?
The interventions under investigation include: Test Product (Bendamustine) (DRUG).
Who is sponsoring clinical trial NCT02162888?
This trial is sponsored by Eagle Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02162888's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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