Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor
Basic Trial Information
|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 Contact Information
Trial Lead Organizations/Sponsors
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01037127
ClinicalTrials.gov processed this data on May 26, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.