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NCT01416428 · ClinicalTrials.gov registry record · Phase 1
Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
NCT01416428: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT01416428 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 210 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (250% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01416428, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 210 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.
Primary Outcome
Phase 1- Determine Maximum Tolerated Dose (MTD) with 3 + 3 Dose Escalation Cohorts in patients hematologic malignancies. Phase 2- The Phase 2 portion of this trial will enroll patients with Multiple Myeloma (MM) and Waldenstrom Macroglobulinemia (WM) into separate arms to assess activity of oprozomib in these patient groups. The purpose of the Phase 2 portion of the study is to estimate the best ORR (for each group separately).
Interventions
- DRUG oprozomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2011-10-15 |
| Est. Completion | 2019-08-12 |
| Phase | Phase 1 |
Why NCT01416428 stopped before completion
NCT01416428 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (250% higher).
The record links to 0 conditions, and to 1 intervention - of which oprozomib is the first listed.
NCT01416428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01416428 about?
NCT01416428 is a clinical study titled "Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies". The purpose of this study is to determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in patients with hematologic malignancies.
What is the current status of trial NCT01416428?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2011-10-15. Estimated completion is 2019-08-12.
What interventions are being tested in trial NCT01416428?
The interventions under investigation include: oprozomib (DRUG).
Who is sponsoring clinical trial NCT01416428?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01416428's enrollment target sits among peer trials
210 245th of 2000 higher than 1,751 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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