An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 37
- 试验地点
- 30
- 主要终点
- Number of Participants With Dose-limiting Toxicities(DLTs)
研究概览
简要总结
FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment.
The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients.
The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma.
Of note, patients who participate in Part A are not allowed to participate in Part B.
Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development.
Part B of the study will no longer be conducted.
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
盲法说明
Part A is open-label.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rogaratinib + Atezolizumab in Part A
Part A: Part A is conducted in patients who are cisplatin-ineligible and have had no prior systemic treatment for locally advanced or metastatic disease.
Patients will receive rogaratinib plus atezolizumab combination treatment.
干预措施: Rogaratinib (BAY1163877) (Drug)
Rogaratinib + Atezolizumab in Part A
Part A: Part A is conducted in patients who are cisplatin-ineligible and have had no prior systemic treatment for locally advanced or metastatic disease.
Patients will receive rogaratinib plus atezolizumab combination treatment.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Number of Participants With Dose-limiting Toxicities(DLTs)
时间窗: Up to 21 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: up to 90 days after the last study medication intake, an average of 60 days
Number of Participants With Drug-related TEAEs
时间窗: up to 90 days after the last study medication intake, an average of 60 days
Number of Participants With Treatment-emergent Serious Adverse Events(TESAEs)
时间窗: up to 90 days after the last study medication intake, an average of 60 days
次要结局
- Objective Response Rate(ORR)(Up to 5 months)
- Maximal Plasma Concentration (Cmax) of Rogaratinib(At cycle 1 Day 1)
- Area Under the Rogaratinib Concentration Versus Time Curve (AUC)(At cycle 1 Day 1, 0-t(last))