An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 14
- 试验地点
- 11
- 主要终点
- Incidence of Adverse Events (Safety and Tolerability)
研究概览
简要总结
This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study.
To be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.
详细描述
Participants may continue treatment until loss of clinical benefit as judged by the investigator, unacceptable toxicity, start of subsequent anticancer therapy, or until any other criterion for withdrawal from the treatment or the study is met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.
- •The participant is currently benefiting from, and expected to continue to benefit from, RVU120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor.
- •The participant does not have access to commercially available comparator anticancer therapy.
- •Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •The participant signed the rollover study ICF prior to any study-related procedure or study data collection.
- •The participant agrees not to donate blood during study participation and until 28 weeks (~6.5 months) after the last dose.
- •The investigator considers the participant to be eligible for participation in the rollover study.
排除标准
- •Presence of toxicity that cannot be adequately managed.
- •Concurrent participation in any therapeutic clinical study other than the parent study.
研究组 & 干预措施
RVU120 single agent
Study intervention is assigned in accordance with the parent protocol and consists of RVU120-based treatment.
干预措施: RVU120 (Drug)
RVU120 + Ruxolitinib
干预措施: Ruxolitinib (Drug)
RVU120 + Ruxolitinib
干预措施: RVU120 (Drug)
结局指标
主要结局
Incidence of Adverse Events (Safety and Tolerability)
时间窗: 12 months
Number and grade of adverse events assessed by CTCAE v5.0
次要结局
- Duration of response(12 months)