drugset / Trial / NCT01228045
A Study of Trastuzumab in Combination With TS-ONE & Cisplatin in First-line Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
Phase 2
Unknown
30 enrolled
National University Hospital, Singapore
National Cancer Centre, Singapore · collab
NaSingle-groupOpen-labelTreatment
Summary
The investigators hypothesis is that the combination of TS-ONE with cisplatin and trastuzumab is safe and as effective as combination treatment for HER2 positive gastric cancer.
Timeline
- Start
- 2011-02
- Primary completion
- 2014-12
- Completion
- 2016-12
Publications
- Background Coussens L, Yang-Feng TL, Liao YC, Chen E, Gray A, McGrath J, Seeburg PH, Libermann TA, Schlessinger J, Francke U, et al. Tyrosine kinase receptor with extensive homology to EGF receptor shares chromosomal location with neu oncogene. Science. 1985 Dec 6;230(4730):1132-9. doi: 10.1126/science.2999974.
- Background Press MF, Pike MC, Chazin VR, Hung G, Udove JA, Markowicz M, Danyluk J, Godolphin W, Sliwkowski M, Akita R, et al. Her-2/neu expression in node-negative breast cancer: direct tissue quantitation by computerized image analysis and association of overexpression with increased risk of recurrent disease. Cancer Res. 1993 Oct 15;53(20):4960-70.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | TS-ONE | Unknown | — | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |