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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01328106
Recruitment Status : Withdrawn (The study was cancelled by the sponsor prior to initiation of study enrollment. No subjects were accrued.)
First Posted : April 4, 2011
Last Update Posted : December 12, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
GNA11 Mutation-positive Metastatic Melanoma GNAQ Mutation-positive Metastatic Melanoma Cancer Metastatic Uveal Melanoma Drug: GSK1120212 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: 1 Drug: GSK1120212
Repeating oral dose

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01328106

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT01328106    
Other Study ID Numbers: 114091
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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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