Open-Label Roll-Over Study to Assess the Long-Term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Most Common Treatment Related Adverse Events
研究概览
简要总结
This phase II trial studies the long-term side effects of ruxolitinib in treating patients with myelofibrosis. Collecting data about the long-term safety and tolerability of ruxolitinib may better help future patients with myelofibrosis.
详细描述
PRIMARY OBJECTIVES:
I. To collect long term safety and tolerability data in patients with myelofibrosis previously treated with ruxolitinib on protocol 2007-0169.
OUTLINE:
Patients continue to receive ruxolitinib orally (PO) once daily (QD) or twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.
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
- •Currently enrolled in study 2007-0169 and benefiting from therapy as determined by treating physician
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study
- •Ability and agreement to attend protocol-specified visits at the study site
- •Able to comprehend and willing to sign the informed consent form
- •Negative pregnancy test in females of childbearing potential; male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner's vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test 7 days before first study treatment
排除标准
- 未提供
研究组 & 干预措施
Treatment (ruxolitinib, follow-up)
Patients continue to receive ruxolitinib PO QD or BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.
干预措施: Long-term Follow-up (Other)
Treatment (ruxolitinib, follow-up)
Patients continue to receive ruxolitinib PO QD or BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.
干预措施: Quality-of-Life Assessment (Other)
Treatment (ruxolitinib, follow-up)
Patients continue to receive ruxolitinib PO QD or BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Most Common Treatment Related Adverse Events
时间窗: to the date of failure or death from any cause, Up to 7 years, 3 months and 24 days
A review of the most common adverse events related to study medication will be performed. Will follow standard reporting guidelines for adverse events. Safety data will be summarized by the number of participants affected.
次要结局
未报告次要终点