Melanoma Clinical Trial
A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
Summary
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.
Eligibility Criteria
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.
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There are 18 Locations for this study
Fayetteville Arkansas, 72703, United States
Tampa Florida, 33612, United States
Portland Oregon, 97201, United States
Portland Oregon, 97239, United States
Portland Oregon, 97239, United States
Allentown Pennsylvania, 18104, United States
Allentown Pennsylvania, 18104, United States
Bethlehem Pennsylvania, 18015, United States
Bethlehem Pennsylvania, 18015, United States
Quakertown Pennsylvania, 18951, United States
Muenchen Bayern, 80337, Germany
München Bayern, 80337, Germany
Essen Nordrhein-westfalen, 45122, Germany
Kiel Schleswig-holstein, 24105, Germany
Luebeck Schleswig-holstein, 23562, Germany
Gera Thüringen, 07548, Germany
Munich , 80337, Germany
Genova , 16132, Italy
Napoli , 80131, Italy
Nijmegen Gelderland, 6525 , Netherlands
Maastricht Limburg, 6229 , Netherlands
Amsterdam Noord-holland, 1066 , Netherlands
Amsterdam Noord-holland, 1066 , Netherlands
Zürich (de) , 08091, Switzerland
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