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This study has been withdrawn prior to enrollment.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:
First received: March 18, 2010
Last updated: March 31, 2011
Last verified: March 2011
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.
GNA11 Mutation-positive Metastatic Melanoma
GNAQ Mutation-positive Metastatic Melanoma
Metastatic Uveal Melanoma
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Objective response rate as assessed by RECIST v1.1 [ Time Frame: At least 12 weeks after initiating study treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of response, progression free survival, overall survival [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
- Safety, tolerability, and population pharmacokinetic parameters [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
Repeating oral dose
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328106
||GSK Clinical Trials
No publications provided
||Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 18, 2010
||March 31, 2011
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site