Clinical trial · Interventional
Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor
An Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in BRAF Mutation-positive Melanoma Subjects Previously Treated With or Without a BRAF Inhibitor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GSK1120212 | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Subjects who have had previous treatment with a BRAF inhibitor.
- interventionNames
- Drug: GSK1120212
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Subjects who have had previous chemotherapy or immunotherapy without a BRAF inhibitor.
- interventionNames
- Drug: GSK1120212
Primary outcomes (3)
- measure
- Number of Participants With Best Confirmed Response
- timeFrame
- From Baseline (Day 1) until the time of the first documented evidence of a confirmed complete response or partial response (up to approximately 25 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTKim KB, Kefford R, Pavlick AC, Infante JR, Ribas A, Sosman JA, Fecher LA, Millward M, McArthur GA, Hwu P, Gonzalez R, Ott PA, Long GV, Gardner OS, Ouellet D, Xu Y, DeMarini DJ, Le NT, Patel K, Lewis KD. Phase II study of the MEK1/MEK2 inhibitor Trametinib in patients with metastatic BRAF-mutant cutaneous melanoma previously treated with or without a BRAF inhibitor. J Clin Oncol. 2013 Feb 1;31(4):482-9. doi: 10.1200/JCO.2012.43.5966. Epub 2012 Dec 17. PMID 23248257