IRB #

IRB00007463

Title

A Phase 2, Open-Label Study to Assess the Safety and Efficacy of Oral MEK162 in Adults with Locally Advanced and Unresectable or Metastatic Malignant Cutaneous Melanoma, Harboring BRAF or NRAS Mutations

Principal Investigator

Michael Heinrich

Study Purpose

The purpose of this study is to find out if MEK162 (the study drug) is safe and what effects (good and/or bad) it has on subjects with locally advanced and unresectable or metastatic malignant cutaneous melanoma with BRAFV600E mutations.

Medical Condition(s)

Melanoma, skin

Eligibility Criteria

* Subjects must have locally advanced or metastatic cutaneous melanoma, not curable with surgery, and measurable with a CT scan
* Subjects must be 18 or older
* Subjects must agree to having tumor biopsies done during the study
* Subjects cannot participate if they have had prior treatment with a MEK-inhibitor

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Minors Included

No

Contact

Clinical Trials hotline: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Novartis

Recruitment End

Compensation Provided

No