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

PHASE1TerminatedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

May 15, 2015

Study Completion Date

July 10, 2019

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.

Trial Locations (7)

Unknown

University of Colorado Anschutz Medical Campus, Aurora

Winship Cancer Institute, Atlanta

Henry Ford Hospital, Detroit

Mary Crowley Cancer Research Centers - Medical City, Dallas

University of Texas MD Anderson Cancer Center, Houston

South Texas Accelerated Research Therapeutics, LLC, San Antonio

Huntsman Cancer Institute, Salt Lake City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY