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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Drug: GSK1120212

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037127

113583

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Cohort A

Experimental group

Description:

Subjects who have had previous treatment with a BRAF inhibitor.

Treatment:

Drug: GSK1120212

Cohort B

Experimental group

Description:

Subjects who have had previous chemotherapy or immunotherapy without a BRAF inhibitor.

Treatment:

Drug: GSK1120212