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

NCT02244112 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-02-21

No results posted yet for this 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

Conditions

  • Advanced Non-Central Nervous System (CNS) Malignancies

Interventions

DRUG

Oprozomib

Subjects will receive oprozomib 270 mg per dose in Part I and oprozomib 300 mg per dose in Part II.

DRUG

Midazolam

Subjects will receive a single oral dose of midazolam 2 mg in Period 1 and oral midazolam 2 mg per dose in Period 2.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-05-15
Completion
2019-07-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02244112 on ClinicalTrials.gov