drugset / Trial / NCT01133977
E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary: * Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of lenvatinib administered in combination with dacarbazine. * Phase II: To evaluate the safety and tolerability of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone. Secondary: -Phase II: To make a preliminary assessment of the efficacy of lenvatinib administered in combination with dacarbazine, compared with dacarbazine alone.
Timeline
- Start
- 2010-04
- Primary completion
- 2014-06
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dacarbazine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Lenvatinib | Small molecule | 16 mg | Oral |
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |
| Subject | Lenvatinib | Small molecule | 22 mg | Oral |