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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01328106
• Other study ID #: 114091
• Status: Withdrawn
• Phase: Phase 2
• First received: March 18, 2010
• Last updated: December 8, 2017
• Start date: November 2010
• Est. completion date: May 2012

Study information

• Verified date: December 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• GNA11 Mutation-positive Metastatic Melanoma
• GNAQ Mutation-positive Metastatic Melanoma
• Melanoma
• Metastatic Uveal Melanoma
• Uveal Neoplasms

Intervention

Drug:
• GSK1120212
Repeating oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate as assessed by RECIST v1.1		At least 12 weeks after initiating study treatment
Secondary	Duration of response, progression free survival, overall survival		Through study completion or early study discontinuation
Secondary	Safety, tolerability, and population pharmacokinetic parameters		Through study completion or early study discontinuation