OHSU

IRB #

IRB00009443

Title

A Randomized Phase III, Open Label, Multicenter, Two-Arm Study Comparing the Efficacy of MEK162 versus Decarbazine in Patients with Advanced Unresectable or Metastatic NRAS Mutation-Positive Melanoma

Principal Investigator

Matthew Taylor

Study Purpose

To find out if MEK162 (the study drug) is more effective compared to dacarbazine (DTIC) in subjects with advanced unresectable or metastatic NRAS melanoma.

Medical Condition(s)

Melanoma

Eligibility Criteria

1. Male or female age 18 years or older
2. Confirmed diagnosis of locally advanced unresectable or metastatic melanoma
3. Presence of NRAS mutation (determined by central laboratory)
4. Have received either: a) No previous treatment or b) One prior line of immunotherapy for metastatic melanoma
5. Able to take oral medications
6. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Until disease progression, unacceptable side effects, of withdrawn consent

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Novartis Pharmaceuticals Corp.

Recruitment End

04/29/2016

Compensation Provided

No


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