Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma

This study has been withdrawn prior to enrollment.
(The study was cancelled by the sponsor prior to initiation of study enrollment. No subjects were accrued.)
Information provided by:
GlaxoSmithKline Identifier:
First received: March 18, 2010
Last updated: April 15, 2015
Last verified: April 2015
The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive GNAQ or GNA11 metastatic melanoma.

Condition Intervention Phase
GNA11 Mutation-positive Metastatic Melanoma
GNAQ Mutation-positive Metastatic Melanoma
Metastatic Uveal Melanoma
Drug: GSK1120212
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in Subjects With Metastatic Uveal Melanoma or With Mutation-Positive GNAQ or GNA11 Metastatic Melanoma

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Objective response rate as assessed by RECIST v1.1 [ Time Frame: At least 12 weeks after initiating study treatment ]

Secondary Outcome Measures:
  • Duration of response, progression free survival, overall survival [ Time Frame: Through study completion or early study discontinuation ]
  • Safety, tolerability, and population pharmacokinetic parameters [ Time Frame: Through study completion or early study discontinuation ]

Enrollment: 0
Study Start Date: November 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: GSK1120212
Repeating oral dose


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not previously treated with a MEK inhibitor.
  • Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment.
  • The patient has a radiographically measurable tumor.
  • ECOG performance status 0, 1, or 2.
  • The patient is able to swallow and retain oral medication.
  • Life expectancy of at least 4 months.
  • Toxicities from previous anti-cancer therapy (except alopecia) are recovered (Grade 1 or less) at the time of enrollment.
  • The patient has adequate organ and bone marrow function.
  • Sexually active patients must use medically acceptable methods of contraception during the course of the study.
  • Female patients of childbearing potential must have a negative serum pregnancy test at screening.

Exclusion Criteria:

  • The patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization.
  • The patient has received experimental therapy within 21 days of starting study drug.
  • The patient has received nitrosourea or mitomycin C within 42 days of starting study drug.
  • The patient has received any herbal medications or palliative radiotherapy within 14 days of starting study drug.
  • The patient is currently receiving anticoagulation therapy that is not well controlled.
  • Ongoing or newly diagnosed eye abnormality other than symptoms due to uveal melanoma.
  • History of retinal vein occlusion or central serous retinopathy.
  • Current severe, uncontrolled systemic disease.
  • History of leptomeningeal disease or spinal cord compression secondary to metastasis.
  • Brain metastasis, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery and the disease has been stable for at least 3 months without steroid use or on a stable dose of steroids for at least 1 month prior to starting study drug. Stability of brain metastases must be confirmed with imaging.
  • The patient has a concurrent, active hematological malignancy or other solid tumor malignancy.
  • History of clinically significant cardiac or pulmonary dysfunction.
  • Allergy or hypersensitivity to components of the GSK1120212 formulation.
  • The patient is pregnant or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01328106

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT01328106     History of Changes
Other Study ID Numbers: 114091
Study First Received: March 18, 2010
Last Updated: April 15, 2015

Additional relevant MeSH terms:
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 25, 2017