An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 7
- 主要终点
- Treatment-related Adverse Events
研究概览
简要总结
Tenalisib has been evaluated as an investigational new drug in number of early clinical studies in patients with relapsed/refractory hematological malignancies and demonstrated acceptable safety and promising efficacy in these patients. Since these advanced relapsed/refractory patients have limited therapeutic options, it is reasonable to continue Tenalisib in responding patients post completion of their participation in previous clinical studies.
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
- •Patients must be currently receiving treatment with Tenalisib on a previously approved protocol.
- •Patients must have had at least one efficacy evaluation in previous study and should have achieved either SD, PR or CR.
- •Patients must have completed at least 6 cycles of Tenalisib in previous study
- •Ability to swallow and retain oral medication.
- •Female patients of child-bearing potential must consent to use two medically acceptable methods of contraception.
- •Male patients must be willing to use adequate contraceptive measures
- •Willingness and ability to comply with trial and follow-up procedures.
- •Willingness to provide new written informed consent.
排除标准
- •Patient has been discontinued from their previous Tenalisib study 4 weeks prior to entering the compassionate use trial.
- •Patient progressed while receiving Tenalisib therapy in his/her previous study.
- •Pregnant or lactating woman.
- •Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
- •Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
研究组 & 干预措施
Tenalisib
Participants receive Tenalisib (RP6530) BID Orally
干预措施: Tenalisib (Drug)
结局指标
主要结局
Treatment-related Adverse Events
时间窗: 2 years
To evaluate the safety and tolerability of Tenalisib as single agent. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time to Disease Progression
时间窗: 2 years
Number of patients with a time to progression. The time to progression is calculated from the day of enrollment in the study to disease progression or death due to any cause.
次要结局
未报告次要终点