Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03410693
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2018-01-19
Brief Title:
Study of Rogaratinib BAY1163877 vs Chemotherapy in Patients With FGFR Fibroblast Growth Factor Receptor-Positive Locally Advanced or Metastatic Urothelial Carcinoma
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Randomized Open Label Multicenter Phase 23 Study to Evaluate the Efficacy and Safety of Rogaratinib BAY1163877 Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FORT-1
Brief Summary:
This is a randomized open-label multicenter Phase 23 study to evaluate the efficacy and safety of rogaratinib BAY 1163877 compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy
The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate before overall survivial of urothelial carcinoma patients with FGFR positive tumors
At randomization patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen Only patients with FGFR1 or 3 positive tumors can be randomized into the study Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions which will be determined centrally using an RNA in situ hybridization RNA-ISH test Approximately 42 of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied
The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate before overall survivial of urothelial carcinoma patients with FGFR positive tumors
At randomization patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen Only patients with FGFR1 or 3 positive tumors can be randomized into the study Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions which will be determined centrally using an RNA in situ hybridization RNA-ISH test Approximately 42 of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004340-11 | EUDRACT_NUMBER | None | None |