NCT00666081撤回1 期
A Phase I Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Potential Anti-cancer Activity of the AKT Inhibitor GSK690693 in Subjects With Relapsed or Refractory Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To characterize a range of doses and to identify the MTD of GSK690693 when dosed daily for 5 consecutive days every 21 days as an IV infusion over 4 h.
研究概览
简要总结
This is a two-part study in subjects with hematologic malignancies designed to find the maximum tolerated dose (MTD) of GSK690693 (Part 1). Part 2 is designed to determine the efficacy of GSK690693 in a subset of subjects with hematologic malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically-confirmed diagnosis of a hematologic malignancy that has relapsed or is refractory after standard therapy, AND that is not associated with human immunodeficiency virus (HIV) infection or solid organ transplant.
- •Signed written consent provided.
- •At least 18 years of age.
- •A woman is eligible to enter and participate in the study if she is of: Non-childbearing potential , or is post-menopausal .
- •A man with a female partner of childbearing potential is eligible to enter and participate in the study if he has either had a prior vasectomy or agrees to use adequate contraception (as described above) during the study, and up to 3 months after last dose of study drug.
- •Fasting glucose that is not elevated.
- •Laboratory values within ranges defined in the protocol
排除标准
- •Previously diagnosed diabetes mellitus (type 1 or 2), or gestational diabetes.
- •Symptomatic or untreated central nervous system (CNS) involvement by the hematologic malignancy (including primary CNS lymphoma). Subjects who were previously treated for CNS involvement, and are asymptomatic without anti-epileptic medications or steroids for at least 2 months are eligible.
- •Subjects who have undergone an allogeneic stem cell transplant.
- •Unresolved toxicity from previous anti-cancer therapy as agreed to by Medical Monitor and the Investigator,.
- •Major surgery within the past 28 days.
- •Chemotherapy, radiotherapy, immunotherapy, or investigational drug therapy within 21 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of study medication. For subjects with acute leukemia, anti-cancer chemotherapy (including corticosteroids) may be administered up to 7 days prior to the first dose of study medication. Chemotherapy given at a dose and schedule that is not expected to have delayed toxicity can be given with an interval of 14 days or more from the first dose. Hydroxyurea may be administered up to 7 days prior to the first dose of study medication.
- •Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids.
- •Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, hepatic, or renal disease).
- •Any female who is pregnant or lactating.
- •Any serious or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety or with obtaining informed consent.
- •Significant ECG abnormalities.
- •Use of medications known to prolong the QTc interval within 14 days (or 5 half-lives) prior to the first dose of study medication.
- •History of myocardial infarction, acute coronary syndromes, unstable angina or coronary angioplasty/stenting/bypass grafting within the past 6 months.
- •Left ventricular ejection fraction (LVEF) less than 50% by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scanning.
- •Use of theophylline within 14 days of the first dose of study medication.
- •Current use of warfarin ≥4 mg per day; however, low molecular weight heparin and prophylactic low-dose warfarin are permitted, if PT/PTT < 1.2 x ULN.
- •Concurrent condition that in the Investigator's opinion would jeopardize the subject's ability to comply with the protocol.
- •History of allergic reactions attributed to compounds of similar chemical composition to GSK690693.
研究组 & 干预措施
Cohort 1
Experimental
GSK690693 for injection. This is a dose escalation study.
干预措施: GSK690693 (Drug)
结局指标
主要结局
To characterize a range of doses and to identify the MTD of GSK690693 when dosed daily for 5 consecutive days every 21 days as an IV infusion over 4 h.
时间窗: 21 days
次要结局
- Blood levels of GSK690693 to derive pharmacokinetic parameters(21 days)
- Plasma pharmacokinetic parameters of GSK690693. To evaluate the response of refractory hematologic malignancies to treatment with GSK690693.(21 days)
- Tumor responses(21 days)
研究者
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