Last updated: 11/03/2018 15:20:08
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Study to determine the effectiveness of GSK1120212 in BRAF mutation-positive melanoma previously treated with or without a BRAF inhibitor
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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)
Number of participants with best confirmed response in the indicated subgroups of participants previously treated with standard therapy but not BRAF inhibitors
Timeframe: From Baseline (Day 1) until the time of the first documented evidence of a confirmed CR or PR (up to approximately 25 weeks)
Number of participants with best unconfirmed response at the time of the interim analysis (Week 8)
Timeframe: Week 8
Secondary outcomes:
Mean plasma concentrations
Timeframe: Day 15, pre-dose, 0.5-2 hours (hrs) post-dose, 2-4 hrs post-dose, and 4-8 hrs post-dose; Week 4, pre-dose; Week 8, pre-dose; Week 12, pre-dose
Number of participants with any Adverse Event (AE)
Timeframe: From the date of the first dose of study medication until 28 days after the last dose (up to 477 days)
Duration of Tumor Response
Timeframe: From the time of the first documented evidence of a confirmed CR or PR until disease progression or death due to any cause (up to approximately 40 weeks)
Progression-free survival (PFS)
Timeframe: Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)
PFS in the indicated subgroups of participants previously treated with standard therapy but not BRAF inhibitors
Timeframe: Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)
Overall Survival
Timeframe: Baseline (Day 1) until death due to any cause (up to 134 weeks)
Number of participants who survived until 6 months, 12 months and 24 months from Baseline
Timeframe: Month 6, Month 12 and Month 24
Number of participants with tumor progression
Timeframe: Baseline (Day 1) until tumor progression (up to approximately 57 weeks)
Interventions:
Enrollment:
97
Primary completion date:
2011-25-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
K Kim, R Kefford, A Pavlick, JR Infante, A Ribas, J Sosman, LA Fecher, M Millward, GA McArthur, P Hwu, R Gonzalez, P Ott, G Long, O Gardner, D Ouellet, Y Xu, D DeMarini, N Le, K Patel, and K Lewis. A Phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) in metastatic BRAF-mutant cutaneous melanoma patients previously treated with or without a BRAF inhibitor. J Clin Oncol. 2013;31(4):482-489.
K Kim, R Kefford, A Pavlick, JR Infante, A Ribas, J Sosman, LA Fecher, M Millward, GA McArthur, P Hwu, R Gonzalez, P Ott, G Long, O Gardner, D Ouellet, Y Xu, D DeMarini, N Le, K Patel, and K Lewis. A Phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) in metastatic BRAF-mutant cutaneous melanoma patients previously treated with or without a BRAF inhibitor. J Clin Oncol. 2013;31(4):482-489.
Medical condition
Cancer
Product
trametinib
Collaborators
Not applicable
Study date(s)
November 2009 to January 2013
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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).
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
East Melbourne, Victoria, Australia, 3002
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77030-4009
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Status
Study Complete
Showing 1 - 6 of 10 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2011-25-07
Actual study completion date
2013-17-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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