At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 (Lenvatinib) in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma.
In Brief
A Phase 2 clinical trial evaluating Lenvatinib and Dacarbazine for Stage IV Melanoma. Completed, enrolled 97 participants across 27 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Lenvatinib tablets administered orally at doses of 16 mg, 20 mg, or 22 mg, once daily continuously over 3 weeks (21 days) during each 21-day cycle
Lenvatinib 20 mg (MTD/recommended Phase 2 dose as determined in Phase 1b of the study) administered once daily continuously over 3 weeks (21 days) during each 21-day cycle
Dacarbazine (1000 mg/m2) infusion over 60 minutes on Day 1 of each 21-day cycle.