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
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
Outcome
Outcome not reported
Stopped (Enrollment): “Why study stopped revised to "A program evaluation identified that the safety profile and pharmacokinetic (PK) characteristics of the formulation used in all oprozomib studies required further optimization and thus enrollment in OPZ009 was halted”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Oprozomib | Small molecule | 270 mg | — |
| Subject | Oprozomib | Small molecule | 300 mg | — |
Indications
No indication recorded.