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

NCT01328106 | Withdrawn Phase 2

• 1 other identifier: 114091
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

GNA11 Mutation-positive Metastatic Melanoma; GNAQ Mutation-positive Metastatic Melanoma; Cancer; Metastatic Uveal Melanoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate as assessed by RECIST v1.1

  At least 12 weeks after initiating study treatment

Secondary Outcomes (2)

• Duration of response, progression free survival, overall survival

  Through study completion or early study discontinuation

• Safety, tolerability, and population pharmacokinetic parameters

  Through study completion or early study discontinuation

Study Arms (1)

1

EXPERIMENTAL

Drug: GSK1120212

Interventions

GSK1120212 DRUG

Repeating oral dose

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Neoplasms; Uveal Melanoma

Interventions

trametinib

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: April 4, 2011
• Study Start: November 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2012
• Last Updated: December 12, 2017

Record last verified: 2017-12