NCT00086528已完成1 期
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses
研究概览
简要总结
The primary objective of this study is as follows:
- To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors.
The secondary objectives of this study are as follows:
- To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors,
- To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors.
The exploratory objective of this study is as follows:
- To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells.
In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study:
- Long-term safety and tolerability of XL647 after repeat administration,
- Tumor response after repeat administration of XL647.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •The subject has a histologically confirmed malignancy that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective,
- •The subject has disease that is assessable by tumor marker, physical, or radiologic means,
- •The subject is ≥18 years old,
- •There have been at least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last treatment regimen included BCNU or mitomycin C),
- •The subject has an ECOG performance status ≤2 (Karnofsky >60%),
- •The subject has a life expectancy of ≥3 months,
- •The subject has normal organ and marrow function (hemoglobin >10g/dL, leukocytes >3,000/mL, absolute neutrophil count >1,500/µL, platelets >100,000/µL, total bilirubin within normal institutional limits of normal,AST (SGOT)/ALT(SGPT) <2.5 times the upper limit of normal, and creatinine within normal limits,
- •The subject is capable of understanding and complying with the protocol and has signed the informed consent document,
- •Sexually active subjects (both male and female) must use an accepted method of contraception during the course of the study,
- •Female subjects of childbearing potential (pre-menopausal) must have a negative pregnancy test.
排除标准
- •The subject has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or has not recovered from AEs due to agents administered more than 4 weeks earlier,
- •The subject has received another investigational agent within 30 days (or 5.5 half-lives) of the first dose of study drug,
- •The subject has known brain metastases,
- •The subject has a corrected QT interval (QTc) of >0.44 seconds,
- •The subject has a history of allergic reactions attributed to aspartame or to any other component in the formulation vehicle,
- •The subject has an uncontrolled intercurrent illness including,but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements,
- •The subject is pregnant or nursing,
- •The subject is known to be positive for the human immunodeficiency virus (HIV).
结局指标
主要结局
To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses
时间窗: First treatment until 30 days post last treatment
次要结局
- To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat dose(At various time points between pre-treatment and post last treatment)
- To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors(At various time points between pre-treatment and post last treatment)
研究者
研究点 (4)
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