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NCT02244112 · ClinicalTrials.gov registry record · Phase 1

A Phase 1 Study of Oprozomib to Assess Food Effect, Drug-Drug Interaction With Midazolam, and Safety and Tolerability in Patients With Advanced Malignancies

A Phase 1 study, sponsored by Amgen.

Terminated
Registry status
Phase 1
Development phase
43
Enrollment target

NCT02244112: Clinical Trial Phase 1 study, sponsored by Amgen.

NCT02244112 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02244112, a Phase 1 study, was terminated before completion, sponsored by Amgen.

TERMINATED
Registry status
Phase 1
Development phase
43 participants
Enrollment target

Study Summary

The purpose of this Phase 1 of the study is to evaluate the effect of food on the pharmacokinetics (PK) of oprozomib, the drug-drug interaction of oprozomib with midazolam, and the safety and tolerability of oprozomib in patients with advanced malignancies

Primary Outcome

Pharmacokinetics (PK) parameter Cmax (maximum plasma concentration of oprozomib) between each diet (oprozomib under fasting versus low-fat, and fasting versus high-fat conditions).

Interventions

  • DRUG Midazolam
  • DRUG Oprozomib

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2014-08
Est. Completion 2019-07-10
Phase Phase 1
Amgen

558 total trials

Why NCT02244112 stopped before completion

NCT02244112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.

NCT02244112 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02244112 about?

NCT02244112 is a clinical study titled "A Phase 1 Study of Oprozomib to Assess Food Effect, Drug-Drug Interaction With Midazolam, and Safety and Tolerability in Patients With Advanced Malignancies". The purpose of this Phase 1 of the study is to evaluate the effect of food on the pharmacokinetics (PK) of oprozomib, the drug-drug interaction of oprozomib with midazolam, and the safety and tolerability of oprozomib in patients with advanced malignancies

What is the current status of trial NCT02244112?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2014-08. Estimated completion is 2019-07-10.

What interventions are being tested in trial NCT02244112?

The interventions under investigation include: Midazolam (DRUG), Oprozomib (DRUG).

Who is sponsoring clinical trial NCT02244112?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02244112's enrollment target sits among peer trials

43 1100th of 2000 higher than 896 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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Source: ClinicalTrials.gov NCT02244112, the US trial registry maintained by the National Library of Medicine. NCT02244112 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.