Ignite Creation Date:
2024-05-06 @ 1:30 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04040725
Status:
WITHDRAWN
Last Update Posted:
2019-12-17
First Post:
2019-07-30
Brief Title:
Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR12 Overexpression
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Clinical Trial of Rogaratinib for High Risk Non-Muscle Invasive Bladder Cancer NMIBC Unresponsive to Bacillus Calmette-Guerin BCG With FGFR1 or FGFR3 Gene Overexpression The Bladder Cancer Signal Seeking Trial BLASST-3
Status:
WITHDRAWN
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn per Bayer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is studying the safety tolerability and tumor activity of the study drug known as rogaratinib as a possible treatment for bladder cancer
Detailed Description:
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied The US Food and Drug Administration FDA has not approved rogaratinib as a treatment for any disease
In this research study the investigators are studying rogaratinib in bladder cancer that has not responded to BCG and overexpresses a protein called FGFR1 or 3
Mutations in FGFR help bladder cancer grow In metastatic cancers that express FGFR 1 or 3 rogaratinib and other inhibitors of FGFR have shown to be an effective treatment
Rogaratinib is an oral drug that inhibits FGFR
To date no therapy has been shown to be effective in controlling bladder cancer after BCG does not work
In this research study the investigators are studying rogaratinib in bladder cancer that has not responded to BCG and overexpresses a protein called FGFR1 or 3
Mutations in FGFR help bladder cancer grow In metastatic cancers that express FGFR 1 or 3 rogaratinib and other inhibitors of FGFR have shown to be an effective treatment
Rogaratinib is an oral drug that inhibits FGFR
To date no therapy has been shown to be effective in controlling bladder cancer after BCG does not work
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