Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Trametinib

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.