NCT01328106撤回2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Objective response rate as assessed by RECIST v1.1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
1
Experimental
干预措施: GSK1120212 (Drug)
结局指标
主要结局
Objective response rate as assessed by RECIST v1.1
时间窗: At least 12 weeks after initiating study treatment
次要结局
- Safety, tolerability, and population pharmacokinetic parameters(Through study completion or early study discontinuation)
- Duration of response, progression free survival, overall survival(Through study completion or early study discontinuation)
研究者
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