MedDataX Logo

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

NCT ID: NCT01037127

Last Updated: 2014-03-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

GSK1120212 BRAF Inhibitor melanoma MEK Inhibitor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A

Subjects who have had previous treatment with a BRAF inhibitor.

Group Type EXPERIMENTAL

GSK1120212

Intervention Type DRUG

Daily oral dosing

Cohort B

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

Group Type EXPERIMENTAL

GSK1120212

Intervention Type DRUG

Daily oral dosing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GSK1120212

Daily oral dosing

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Aurora, Colorado, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Westmead, New South Wales, Australia

Site Status

GSK Investigational Site

East Melbourne, Victoria, Australia

Site Status

GSK Investigational Site

Nedlands, Western Australia, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23248257 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

113583

Identifier Type: -

Identifier Source: org_study_id