drugset / Trial / NCT02244112

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

Phase 1 Terminated 43 enrolled Amgen
Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 2 mg Oral
Subject Oprozomib Small molecule 270 mg
Subject Oprozomib Small molecule 300 mg

Indications

No indication recorded.