NCT00773929已完成1 期
A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced 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
- 60
- 试验地点
- 1
- 主要终点
- Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593
研究概览
简要总结
The purpose of this study is to determine the safety and toxicity profile of TAK-593 and determine the maximum tolerated dose of TAK-593.
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
- •≥ 18 years of age diagnosed with advanced solid tumor cancer that failed to respond to standard therapies and where no other treatment options are available.
- •No prior chemotherapy
- •Able to understand and follow study requirements
- •Subject or subject's legal representative signs a written, informed consent form prior to beginning any study procedures.
- •Women who are post-menopausal for at least 1 year before screening or surgically sterile
- •Women of childbearing potential agree to practice two effective methods of birth control from the time of signing the informed consent form through 30 days after the last dose of the study drug or agree to completely abstain from heterosexual intercourse.
- •Men who agree to practice an effective method of birth control for the entire study treatment period and through 30 days after the last dose of study drug or completely agree to abstain from heterosexual intercourse.
- •Ability to swallow and retain oral medication
- •Meet study specific laboratory test standards for bone marrow function, liver function, blood pressure, and renal function.
排除标准
- •Cancer has spread to the brain
- •History of another cancer diagnosed or treated within the past 3 years.
- •Severe cardiovascular issues including heart attack within the past 6 months, unstable angina or arrhythmias that require treatments.
- •Severe thyroid disease
- •Unstable angina
- •Arrhythmia issues
- •History of bleeding issues
- •Serious wounds, ulcers or bone fractures that do not heal
- •Subject is pregnant or breast feeding
- •Subject has illnesses or conditions that may affect their ability to participate in the study
- •Subject participated in another clinical study/post marketing clinical study within 4 weeks prior to the start of this trial.
研究组 & 干预措施
1
Experimental
3-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort
干预措施: TAK-593 (Drug)
结局指标
主要结局
Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593
时间窗: 18-24 months
次要结局
- Response outcomes including objective response and clinical benefit response.(18-24 months)
研究者
研究点 (1)
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