|Phase II||Biomarker/Laboratory analysis, Treatment||Completed||18 and over||Pharmaceutical / Industry||113583|
MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity.
- Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior chemotherapy or immunotherapy, without treatment with a BRAF inhibitor.
- Documented positive BRAF mutation (V600E, V600K, or V600D).
- Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to enrollment.
- The subject must have a radiographically measurable tumor.
- The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
- Able to swallow and retain oral medication.
- Sexually active subjects must use acceptable methods of contraception during the course of the study.
- Adequate organ system function and blood cell counts.
- The subject has had major surgery or received certain types of cancer therapy within 21 days before starting the study.
- Previous treatment with a MEK inhibitor.
- Current use of a prohibited medication listed in the protocol.
- Uncontrolled glaucoma.
- Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery, and the disease has been stable for at least 2 months prior to enrollment.
- Current severe or uncontrolled systemic disease.
- History of clinically significant heart, lung, or eye/vision problems.
- Significant unresolved side effects from previous anti-cancer therapy.
- The subject is pregnant or breastfeeding.
Trial Lead Organizations/Sponsors
|GSK Clinical Trials||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01037127
ClinicalTrials.gov processed this data on October 17, 2013
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