drugset / Trial / NCT01832727
Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives are: Phase 1b: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oprozomib given orally, once daily, on 2 different schedules. * To evaluate safety and tolerability Phase 2: * To estimate the overall response rate (ORR). * To evaluate safety and tolerability
Timeline
- Start
- 2013-07-02
- Primary completion
- 2019-06-25
- Completion
- 2019-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oprozomib | Small molecule | 180 mg | Oral |
| Subject | Oprozomib | Small molecule | 210 mg | Oral |
| Subject | Oprozomib | Small molecule | 240 mg | Oral |
| Subject | Oprozomib | Small molecule | 270 mg | Oral |
| Subject | Oprozomib | Small molecule | 300 mg | Oral |
| Subject | Oprozomib | Small molecule | 330 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |