Clinical trial NCT01328106: Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: GNA11 Mutation-positive Metastatic Melanoma
GNAQ Mutation-positive Metastatic Melanoma
Cancer
Metastatic Uveal Melanoma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate as assessed by RECIST v1.1
timeFrame: At least 12 weeks after initiating study treatment
Secondary outcomes:
measure: Duration of response, progression free survival, overall survival
timeFrame: Through study completion or early study discontinuation
measure: Safety, tolerability, and population pharmacokinetic parameters
timeFrame: Through study completion or early study discontinuation
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: