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E7080 in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma

Stage IV Melanoma Clinical Trial

Official title:
An Open-Label, Multicenter, Randomized, Phase Ib/II Study of E7080 in Combination With Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients With Stage IV Melanoma.

Clinical Trial Summary

Primary:

- Phase Ib: To define the safety, tolerability and maximum tolerated dose (MTD) of E7080 administered in combination with dacarbazine.

- Phase II: To evaluate the safety and tolerability of E7080 administered in combination with dacarbazine, compared with dacarbazine alone.

Secondary:

-Phase II: to make a preliminary assessment of the efficacy of E7080 administered in combination with dacarbazine, compared with dacarbazine alone.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01133977
Study type Interventional
Source Eisai Inc.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date December 2012
Completion date August 2014
View Details
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