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NCT01832727 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT01832727: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT01832727 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01832727, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
The primary objectives are: Phase 1b: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oprozomib given orally, once daily, on 2 different schedules. * To evaluate safety and tolerability Phase 2: * To estimate the overall response rate (ORR). * To evaluate safety and tolerability
Primary Outcome
Toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.03) were considered DLTs if judged by the investigator to be related to oprozomib and occurred in the first 14 days of treatment, with treatment at the dose to be studied (i.e., Cycle 1 for continuous dosing or Cycle 2 for step-up dosing). A DLT was categorized as nonhematologic or hematologic. Examples include: * Any ≥ Grade 3 nonhematologic AE, with exceptions or qualifications such as Grade 3 nausea, vomiting, diar
Interventions
- DRUG Dexamethasone
- DRUG Oprozomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-07-02 |
| Est. Completion | 2019-06-25 |
| Phase | Phase 1 |
Why NCT01832727 stopped before completion
NCT01832727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01832727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01832727 about?
NCT01832727 is a clinical study titled "Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma". The primary objectives are: Phase 1b: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oprozomib given orally, once daily, on 2 different schedules. * To evaluate safety and tolerability Phase 2: * To estimate the overall response rate (ORR). * To evaluate s...
What is the current status of trial NCT01832727?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2013-07-02. Estimated completion is 2019-06-25.
What interventions are being tested in trial NCT01832727?
The interventions under investigation include: Dexamethasone (DRUG), Oprozomib (DRUG).
Who is sponsoring clinical trial NCT01832727?
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 NCT01832727's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 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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