NCT01266954已完成1 期
An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The amount of GSK2141795 in the blood (ng/ml) from baseline
研究概览
简要总结
The purpose of this study is to explore the potential dose response relationship between the pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor biopsies will be done prior to initiation of dosing and sequentially at select time points during the first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689 for the same schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Capable of giving written informed consent
- •Females of non-childbearing potential, 18 years or older with ovarian cancer
- •Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent ovarian cancer
- •Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent uterine or gastro-oesophageal tumors (these tumor types will only be included if there is poor enrollment of patients with ovarian cancer)
- •Disease at least 2 cm suitable for assessment by imaging
- •Performance Status score of 0, 1 or 2 according to the Eastern Cooperative Oncology Group scale
- •Adequate organ systems function
排除标准
- •Chemotherapy, radiotherapy, or immunotherapy within 28 days prior to the first dose of GSK2141795
- •Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of GSK2141795
- •Current use of a prohibited medication
- •Anticoagulants at therapeutic doses are permitted only after consultation with the GSK Medical Monitor
- •Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption
- •Any major surgery within the last four weeks of screening
- •Unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy
- •Previously diagnosed diabetes mellitus
- •Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids
- •Any serious or unstable pre-existing medical, psychiatric, or other condition
- •Symptomatic or untreated CNS metastases or leptomeningeal involvement
- •Evidence of severe or uncontrolled systemic diseases
- •QTc interval ≥ 470 msecs
- •Other clinically significant ECG abnormalities
- •History of myocardial infarction, acute coronary syndromes
- •Class III or IV heart failure
- •Pregnant or Lactating patients
- •History of hepatitis B or C or HIV
研究组 & 干预措施
Stage 1
Experimental
Three to six patients on a medium dose of GSK2141795 for four weeks
干预措施: GSK2141795 (Drug)
Stage 2
Experimental
Nine to eighteen subjects on a low, medium or high dose of GSK2141795 for four weeks
干预措施: GSK2141795 (Drug)
结局指标
主要结局
The amount of GSK2141795 in the blood (ng/ml) from baseline
时间窗: 6 months
次要结局
- The net unidirectional uptake of FDG (Ki) from baseline(6 months)
- The change in size of tumor from baseline (RECIST Criteria)(6 months)
研究者
研究点 (1)
Loading locations...
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