drugset / Trial / NCT00963820
Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine the safety profile, tolerability, and maximum tolerated dose of ixazomib citrate (MLN9708) when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM). Secondary objectives include pharmacokinetics and response rates.
Timeline
- Start
- 2009-10
- Primary completion
- 2012-09
- Completion
- 2014-01
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.
- Kumar SK, Bensinger WI, Zimmerman TM, Reeder CB, Berenson JR, Berg D, Hui AM, Gupta N, Di Bacco A, Yu J, Shou Y, Niesvizky R. Phase 1 study of weekly dosing with the investigational oral proteasome inhibitor ixazomib in relapsed/refractory multiple myeloma. Blood. 2014 Aug 14;124(7):1047-55. doi: 10.1182/blood-2014-01-548941. Epub 2014 Jun 5.
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 | 2.23 mg/m2 | Oral |
| Subject | Ixazomib | Unknown | 2.97 mg/m2 | Oral |
| Subject | Ixazomib | Unknown | 3.95 mg/m2 | Oral |