drugset / Trial / NCT00932698
Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of Ixazomib administered orally in participants with relapsed and/or refractory multiple myeloma.
Timeline
- Start
- 2009-10-12
- Primary completion
- 2013-06-20
- Completion
- 2017-05-23
Publications
- Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3.
- Richardson PG, Baz R, Wang M, Jakubowiak AJ, Laubach JP, Harvey RD, Talpaz M, Berg D, Liu G, Yu J, Gupta N, Di Bacco A, Hui AM, Lonial S. Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients. Blood. 2014 Aug 14;124(7):1038-46. doi: 10.1182/blood-2014-01-548826. Epub 2014 Jun 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ixazomib | Unknown | 0.24 mg/m2 | Oral |
| Subject | Ixazomib | Unknown | 0.48 mg/m2 | Oral |
| Subject | Ixazomib | Unknown | 0.8 mg/m2 | Oral |
| Subject | Ixazomib | Unknown | 1.2 mg/m2 | Oral |
| Subject | Ixazomib | Unknown | 1.68 mg/m2 | Oral |
| Subject | Ixazomib | Unknown | 2 mg/m2 | Oral |
| Subject | Ixazomib | Unknown | 2.23 mg/m2 | Oral |