FORAY: A Phase 2, Randomized, Open-Label Study Evaluating Vepugratinib in Adults With FGFR3 Altered Low Grade, Intermediate Risk, Non-muscle Invasive Bladder Cancer and Low Grade Upper Tract Urothelial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Number of Participants with LG IR NMIBC with Complete Response
研究概览
简要总结
The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC). Safety tests will also be conducted.
For each participant, the study will last up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •All Participants:
- •Have a PS of 0 to 2 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale
- •Have histologically confirmed LG NMIBC.
- •Have LG IR NMIBC at time of screening
- •Have a documented qualifying fibroblast growth factor receptor 3 protein (FGFR3) mutation or fusion
- •Have histologically confirmed LG UTUC.
排除标准
- •All Participants
- •Have had a prior positive urine cytology within 6 weeks of first day of treatment.
- •Have received prior local instillation (for example, intravesical chemotherapy, Bacillus Calmette-Guerin, Jelmyto) therapy within 8 weeks of the first day of treatment.
- •Have synchronous UTUC disease.
- •Have presence of, or history of, high-grade urothelial carcinoma within 3 years of the first day of treatment, or presence of, or history of, carcinoma in situ.
- •Have presence of bladder tumors at the time of enrollment.
- •Have presence of, or history of, high-grade urothelial carcinoma or carcinoma in situ.
研究组 & 干预措施
Cohort A: Vepugratinib
Vepugratinib will be administered orally to participants with low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC)
干预措施: Vepugratinib (Drug)
Cohort B: Vepugratinib
Vepugratinib will be administered orally to participants with low-grade upper tract urothelial carcinoma (LG UTUC)
干预措施: Vepugratinib (Drug)
结局指标
主要结局
Number of Participants with LG IR NMIBC with Complete Response
时间窗: Baseline, 2 Years
Complete response rate is defined as negative cystoscopy and negative cytology .
Number of Participants with LG UTUC with Complete Response
时间窗: Baseline, 2 Years
Complete response rate is defined as negative uterorenoscopy or nephroscopy assessment and negative cytology, per investigator assessment.
次要结局
- Duration of Response(Baseline, 5 Years)
- Time to Recurrence(Baseline, 5 Years)