NCT04040725

Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 U.S. 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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Rogaratinib	Rogaratinib is an oral drug that inhibits FGFR. Mutations in FGFR help bladder cancer grow.

Timeline

• Start date: 2019-11-27
• Primary completion: 2019-11-27
• Completion: 2019-11-27
• First posted: 2019-08-01
• Last updated: 2019-12-17

Regulatory

• FDA-regulated drug study