drugset / Trial / NCT00280397
An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.
Timeline
- Start
- 2006-01
- Primary completion
- 2008-09
- Completion
- 2008-11
Publications
- Koyama N, Saito K, Nishioka Y, Yusa W, Yamamoto N, Yamada Y, Nokihara H, Koizumi F, Nishio K, Tamura T. Pharmacodynamic change in plasma angiogenic proteins: a dose-escalation phase 1 study of the multi-kinase inhibitor lenvatinib. BMC Cancer. 2014 Jul 21;14:530. doi: 10.1186/1471-2407-14-530.
- Yamada K, Yamamoto N, Yamada Y, Nokihara H, Fujiwara Y, Hirata T, Koizumi F, Nishio K, Koyama N, Tamura T. Phase I dose-escalation study and biomarker analysis of E7080 in patients with advanced solid tumors. Clin Cancer Res. 2011 Apr 15;17(8):2528-37. doi: 10.1158/1078-0432.CCR-10-2638. Epub 2011 Mar 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 0.5 mg | Oral |
| Subject | Lenvatinib | Small molecule | 1 mg | Oral |
| Subject | Lenvatinib | Small molecule | 2 mg | Oral |
| Subject | Lenvatinib | Small molecule | 4 mg | Oral |
| Subject | Lenvatinib | Small molecule | 6 mg | Oral |
| Subject | Lenvatinib | Small molecule | 9 mg | Oral |
| Subject | Lenvatinib | Small molecule | 13 mg | Oral |
| Subject | Lenvatinib | Small molecule | 16 mg | Oral |
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |
Indications
No indication recorded.