An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to identify the maximum tolerated dose
研究概览
简要总结
This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.
详细描述
This is a multi-center, open-label, dose escalation study intended to identify the MTD of atiprimod alone and the MTD of atiprimod when given in combination with ursodiol. The atiprimod dose will be escalated in sequential cohorts. Ten dose levels of atiprimod are planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420, and 480 mg/day to be given orally. Six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480 mg/day to be given orally. The dose of ursodiol will remain constant for all cohorts (300 mg ursodiol orally three times a day everyday). Up to 105 patients will participate depending on the level at which toxicity is observed. Patients will be assigned to dose level in the order of study entry.
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
- •documented history of multiple myeloma,
- •failed at least two prior regimens for multiple myeloma,
- •18 years of age or older,
- •ECOG(Zubrod)PS of 0 to 2,
- •screening evaluation for determining eligibility prior to enrollment,
- •signed informed consent form,
排除标准
- •concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
- •renal insufficiency (serum creatinine levels of > 2mg/dL),
- •mucosal bleeding,
- •any condition which in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.
- •clinically relevant active infection or co-morbid medical conditions.
- •prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
- •patients with non-secretory myeloma.
- •as atiprimod is a potent inhibitor or CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.
结局指标
主要结局
The primary objective of this study is to identify the maximum tolerated dose
时间窗: 1 year
次要结局
- The secondary objective of this study is to measure the pharmacokinetics of(1 year)