Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression
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|ClinicalTrials.gov Identifier: NCT04040725|
Recruitment Status : Withdrawn (Withdrawn per Bayer)
First Posted : August 1, 2019
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Rogaratinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 27, 2019|
|Actual Primary Completion Date :||November 27, 2019|
|Actual Study Completion Date :||November 27, 2019|
Rogaratinib is an oral drug that inhibits FGFR. Mutations in FGFR help bladder cancer grow.
- Complete Response [ Time Frame: 6 months ]Absence of any cancer in the bladder (No carcinoma in situ or new lesions) on examination with TURBT
- Duration of Response [ Time Frame: 2 years ]Duration of time from study entry until appearance of any cancer in the bladder (No carcinoma in situ or new lesions) on examination with TURBT
- Rate Toxicity Occurs [ Time Frame: 2 years ]Percentage of patients with a side effect from rogaritinib while on study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040725
|Principal Investigator:||Bradley A. McGregor, MD||Dana-Farber Cancer Institute|