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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01037127




Registration number
NCT01037127
Ethics application status
Date submitted
25/11/2009
Date registered
21/12/2009
Date last updated
31/03/2014

Titles & IDs
Public title
Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor
Scientific 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
Secondary ID [1] 0 0
113583
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1120212

Experimental: Cohort A - Subjects who have had previous treatment with a BRAF inhibitor.

Experimental: Cohort B - Subjects who have had previous chemotherapy or immunotherapy without a BRAF inhibitor.


Treatment: Drugs: GSK1120212
Daily oral dosing
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Best Confirmed Response
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Number of Participants With Best Confirmed Response in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors
Timepoint [2] 0 0
From Baseline (Day 1) until the time of the first documented evidence of a confirmed CR or PR (up to approximately 25 weeks)
Primary outcome [3] 0 0
Number of Participants With Best Unconfirmed Response at the Time of the Interim Analysis (Week 8)
Timepoint [3] 0 0
Week 8
Secondary outcome [1] 0 0
Mean Plasma Concentrations
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Number of Participants With Any Adverse Event (AE)
Timepoint [2] 0 0
From the date of the first dose of study medication until 28 days after the last dose (up to 477 days)
Secondary outcome [3] 0 0
Duration of Tumor Response
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Progression-free Survival (PFS)
Timepoint [4] 0 0
Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)
Secondary outcome [5] 0 0
PFS in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors
Timepoint [5] 0 0
Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Baseline (Day 1) until death due to any cause (up to 134 weeks)
Secondary outcome [7] 0 0
Number of Participants Who Survived Until 6 Months, 12 Months and 24 Months From Baseline
Timepoint [7] 0 0
Month 6, Month 12 and Month 24
Secondary outcome [8] 0 0
Number of Participants With Tumor Progression
Timepoint [8] 0 0
Baseline (Day 1) until tumor progression (up to approximately 57 weeks)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [2] 0 0
GSK Investigational Site - East Melbourne
Recruitment hospital [3] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01037127
Trial related presentations / publications
Kim 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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01037127