An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- The primary objectives of this study are to identify the maximum tolerated dose
研究概览
简要总结
The primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.
详细描述
The primary objectives of this study are to identify the maximum tolerated dose(MTD) and to evaluate safety of atiprimod in patients with advanced cancer.
The secondary objectives of this study are 1) to measure the pharmacokinetics of atiprimod and 2) to evaluate the efficacy of atiprimod treatment in patients with advanced cancers and 3) to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
- •estimated life expectancy of at least 12 weeks.
- •must have evaluable disease.
- •ECOG(Zubrod) PS of 0 to 2
- •sign informed consent.
- •age 13 years or more at time of signing informed consent.
排除标准
- •renal insufficiency
- •concomitant radiotherapy, chemotherapy or other investigational therapies.
- •peripheral neuropathy grade 3 or greater (NCI CTC version 3 grading)
- •evidence of clinically significant mucosal or internal bleeding
- •any condition that 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 serious co-morbid medical conditions.
- •as atiprimod is a potent inhibitor of 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 objectives of this study are to identify the maximum tolerated dose
MTD) and to evaluate the safety of atiprimod when given in doses starting at
60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in
patients with advanced cancer.
次要结局
- The secondary objectives of this study are to measure the pharmacokinetics of
- atiprimod, to evaluate the efficacy of atiprimod treatment in patients with
- advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and
- capsules at the starting dose, with the intent of switching to capsules for
- the dose escalation if the capsules pose no safety issues.