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This study evaluates the drug MEK162 as a single agent in patients with advanced cutaneous (skin) melanoma carrying a BRAF or NRAS gene mutation, not curable by surgery. It included patients with Stage IIIB-IV melanoma. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.