An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 10
- 主要终点
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies.
详细描述
A Phase 2 Open-Label, Multicenter, Rollover Study to evaluate the long term safety and tolerability of Pemigatinib and to provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently enrolled and receiving treatment in an Incyte-sponsored clinical study (parent protocol) of pemigatinib as monotherapy or combination therapy.
- •Currently benefiting from and tolerating treatment with pemigatinib, as determined by the investigator.
- •Demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
- •Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures.
- •Currently have no evidence of progressive disease, as determined by the investigator, following treatment with pemigatinib as monotherapy or combination therapy.
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Able to access pemigatinib commercially or outside of a clinical trial.
- •Permanently discontinued from the parent protocol for any reason.
- •No longer meet the inclusion/exclusion criteria from the parent protocol if still receiving treatment.
- •Women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study.
研究组 & 干预措施
Study Treatment 1: Pemigatinib (INCB054828)
Pemigatinib will be taken orally once daily
干预措施: Pemigatinib (Drug)
Study Treatment 2: Pemigatininb+ Retifanlimab
Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks
干预措施: Pemigatinib (Drug)
Study Treatment 2: Pemigatininb+ Retifanlimab
Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks
干预措施: Retifanlimab (Drug)
Study Treatment 3: Pemigatininb + Pembrolizumab
Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions.
干预措施: Pemigatinib (Drug)
Study Treatment 3: Pemigatininb + Pembrolizumab
Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
时间窗: up to at least 30 days after the last dose of study treatment or until toxicities resolve, return to baseline, or are deemed irreversible, whichever was longer (up to 1010 days)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and until 30 days after the last dose of study drug.
次要结局
未报告次要终点