drugset / Trial / NCT01680991
A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+) malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated time on study treatment is 24 weeks.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-12
- Completion
- 2014-12
Publications
- Qin Y, Song Y, Shen Z, Du X, Ji W, Hsu W, Zhu J, Shi Y. Safety and efficacy of obinutuzumab in Chinese patients with B-cell lymphomas: a secondary analysis of the GERSHWIN trial. Cancer Commun (Lond). 2018 May 30;38(1):31. doi: 10.1186/s40880-018-0300-5.
- Zhai J, Qin Y, Zhu J, Song Y, Shen Z, Du X, Jamois C, Brewster M, Shi Y, Shi J. Pharmacokinetics of obinutuzumab in Chinese patients with B-cell lymphomas. Br J Clin Pharmacol. 2017 Jul;83(7):1446-1456. doi: 10.1111/bcp.13232. Epub 2017 Feb 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |