A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

Status:	Active, not recruiting
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	6/1/2018
Start Date:	March 2011
End Date:	June 30, 2019

A Phase II, 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 BRAFV600 or NRAS Mutations

The study will assess the safety and efficacy of single-agent MEK162 in adult patients with
locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring
BRAFV600E or NRAS mutations.

Inclusion Criteria:

- Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not
potentially curable with surgery

- BRAF or NRAS mutation in tumor tissue

- All patients enrolled should provide sufficient fresh or archival tumor sample at
baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses
described in the protocol

- Evidence of measurable tumor disease as per RECIST

- WHO performance status of 0-2

- Adequate organ function and laboratory parameters

Exclusion Criteria:

- History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO)
or any eye condition that would be considered a risk factor for CSR or RVO

- Patients with unstable CNS metastasis

- Prior treatment with a MEK- inhibitor

- Impaired cardiovascular function

- HIV, active Hepatitis B, and/or active Hepatitis C infection

- Pregnant or nursing (lactating) women

- Women of child-bearing potential UNLESS they comply with protocol contraceptive
requirements

Other protocol-defined inclusion/exclusion criteria may apply.

We found this trial at

sites

Highlands Oncology Group Dept of Highlands Oncology Grp

Fayetteville, Arkansas 72703

from

Fayetteville, AR