NCT00464113终止1 期
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia (Ph+ ALL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Exelixis
- 入组人数
- 49
- 试验地点
- 6
- 主要终点
- Safety, tolerability, and maximum tolerated dose of once-weekly and/or twice-weekly 1-hour intravenous (IV) infusion of XL228
研究概览
简要总结
The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has a confirmed pathologic diagnosis as evidenced by the presence of the BCR-Abl translocation [t(9;22)] by fluorescence in situ hybridization (FISH), cytogenetics, or quantitative polymerase chain reaction (QPCR) of one of the following:
- •Chronic phase (CP)
- •Accelerated phase (AP)
- •Blast phase (BP) OR
- •The subject has one of the following:
- •Known T315I Abl mutation
- •Known resistance to or intolerance of imatinib and dasatinib
- •At least one prior anti-leukemia therapy, including, but not limited to, interferon, imatinib, or dasatinib
- •The subject is at least 18 years old.
- •The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •The subject has adequate organ function.
- •The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
- •Sexually active subjects must use an accepted method of contraception during the course of the study.
- •Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
排除标准
- •The subject has received interferon, imatinib, or dasatinib within 7 days of the first dose of XL
- •The subject has received an investigational agent or radiotherapy within 28 days of the first dose of XL
- •The subject has received immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus for graft-versus-host disease [GVHD]) within 28 days prior to the first dose of XL
- •The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from toxicities related to peripheral stem cell or bone marrow transplant.
- •The subject has not recovered to CTCAE v3.0 Grade ≤1 from adverse events (AEs) due to investigational drugs or other medications.
- •The subject has known allergy or hypersensitivity to any component of the investigational drug product.
- •The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, 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 breastfeeding.
- •The subject is known to be positive for the human immunodeficiency virus (HIV).
- •The subject has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.
研究组 & 干预措施
1
Experimental
once-weekly dosing
干预措施: XL228 (Drug)
2
Experimental
twice-weekly dosing
干预措施: XL228 (Drug)
结局指标
主要结局
Safety, tolerability, and maximum tolerated dose of once-weekly and/or twice-weekly 1-hour intravenous (IV) infusion of XL228
时间窗: Assessed at periodic visits
次要结局
- Evaluate plasma pharmacokinetics and estimate renal elimination of once-weekly and twice-weekly 1-hour IV infusion of XL228(Assessed at periodic visits)
- Exploratory Outcomes: Evaluate hematologic and cytogenetic response and pharmacodynamic correlates of XL228 activity(Assessed at periodic visits)
研究者
研究点 (6)
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