NCT00595829终止1 期
A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Polycythemia Vera
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
- 3
- 试验地点
- 5
- 主要终点
- Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor XL019 administered orally in adults with Polycythemia Vera.
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 diagnosis of polycythemia vera (PV), and has failed, or is intolerant of, standard therapies or refuses to take standard medications.
- •The subject is ≥18 years old.
- •The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •The subject has adequate organ function.
- •Subjects who have received phlebotomy due to PV must have documented phlebotomy history for 12 weeks prior to enrollment.
- •The subject has the capability of understanding the informed consent document and has signed the informed consent document.
- •Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
- •Female subjects of childbearing potential must have a negative pregnancy test at screening.
- •The subject has had no other diagnosis of malignancy or evidence of other malignancey for 2 years prior to screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).
排除标准
- •The subject has received treatment for PV within 14 days prior to first dose of XL019
- •The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 3 months, or cardiac arrhythmias.
- •The subject is pregnant or breastfeeding.
- •The subject is known to be positive for the human immunodeficiency virus (HIV).
- •The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
研究组 & 干预措施
1
Experimental
干预措施: XL019 (Drug)
结局指标
主要结局
Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV)
时间窗: Assessed at each visit
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019
时间窗: Assessed at periodic visits
次要结局
- Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV(Assessed during periodic visits)
- Evaluate preliminary efficacy of XL019(Assessed weekly or bi-weekly)
研究者
研究点 (5)
Loading locations...
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