EUCTR2010-023015-33-GB进行中（未招募）1 期
MEK114375: A Rollover Study to Provide Continued Treatment with GSK1120212 to Subjects with Solid Tumors and Leukemia - Rollover study
GlaxoSmithKline Research and Development LtdŒÚ°0 个研究点目标入组 159 人开始时间: 2012年7月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 159
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •A subject will be eligible for inclusion in this study only if all of the
- •following criteria apply:
- •1. Has provided signed informed consent for this study.
- •2. Has demonstrated compliance during the parent study with study
- •treatment(s), treatment visit schedules, and the requirements and
- •restrictions listed in the consent form.
- •3. Is currently participating in GSK1120212 study and is receiving
- •treatment with GSK1120212.
- •4. Is currently receiving clinical benefit as determined by the
- •investigator from previous treatment with GSK1120212 either as
- •monotherapy or as part of a combination treatment regimen.
- •5. Continued ability to swallow and retain orally administered study
- •treatment(s) and does not have any clinically significant GI
- •abnormalities that may alter absorption such as malabsorption
- •syndrome or major resection of the stomach or bowels.
- •6. Male subjects with a female partner of childbearing potential must be
- •willing to continue practicing the same acceptable method of
- •contraception as used in the parent study during the rollover study and
- •for at least 16 weeks after the last dose of GSK1120212.
- •7. Female subjects of childbearing potential, as defined in the parent
- •study, must be willing to continue practicing the same acceptable
- •method of contraception as used in the parent study during the rollover
- •study and for at least 4 months after the last dose of GSK1120212.
- •8. Female subjects of childbearing potential, as defined in parent study,
- •must have negative serum pregnancy tests at the time of transition to
- •this study.
- •9. Subjects enrolled in France: In France, a subject will be eligible for
- •inclusion in this study only if either affiliated to or a beneficiary of a
- •social security category.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in
- •this study:
- •1. Permanent discontinuation of GSK1120212 in the parent study due to
- •toxicity or disease progression.
- •2. Local access to commercially available GSK1120212.
- •3. Current use of a prohibitive medication(s) as listed in Section 6.2.
- •NOTE: Use of anticoagulants such as warfarin is permitted; however, the
- •international normalization ratio (INR) must be monitored in accordance
- •with local institutional practice.
- •4. Any unresolved toxicity that meets the study treatment
- •discontinuation or study withdrawal criteria from the parent study at the
- •time of transition to this study.
- •5. Bazett-corrected QT (QTcB) interval =501 msec at the time of
- •transition to this study
- •6. Left ventricular ejection fraction (LVEF) < institutional lower limit of
- •normal (LLN) by ECHO (preferred) or MUGA scan at the time of transition
- •to this study.
- •7. Nursing female.
- •8. Any serious and/or unstable pre-existing medical, psychiatric
- •disorder or other conditions at the time of transition to this study that
- •could interfere with subject's safety, obtaining informed consent or
- •compliance to the study procedures, in the opinion of the investigator or
- •GSK Medical Monitor.
研究者
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