Phase 2
N=97
Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01037127 ↗Enrolled (actual)
97
Serious AEs
18.6%
Results posted
Mar 2014
Primary outcome: Primary: Number of Participants With Best Confirmed Response — 0; 1; 0; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK1120212 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Best Confirmed Response |
0; 1; 0; 13 | — |
| PRIMARY Number of Participants With Best Confirmed Response in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors |
0; 1; 1; 1; 0; 2 | — |
| PRIMARY Number of Participants With Best Unconfirmed Response at the Time of the Interim Analysis (Week 8) |
0; 0; 0; 6 | — |
| SECONDARY Mean Plasma Concentrations |
12.3; 11.6; 18.6; 15.2; 23.6; 20.8 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) |
39; 57 | — |
| SECONDARY Duration of Tumor Response |
5.7 | — |
| SECONDARY Progression-free Survival (PFS) |
1.8; 4.0 | — |
| SECONDARY PFS in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors |
3.0; 4.6; 4.6; 5.3; 3.7 | — |
| SECONDARY Overall Survival |
5.5; 14.3 | — |
| SECONDARY Number of Participants Who Survived Until 6 Months, 12 Months and 24 Months From Baseline |
20; 12; 15; 24; 3; 1 | — |
| SECONDARY Number of Participants With Tumor Progression |
35; 43; 21; 22; 8; 11 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01037127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.