A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Self-administered 60mg dose Oral tablet(s) given daily
Self-administered 80mg dose Oral tablet(s) given daily
To be determined: Self-administered Oral tablet(s) given daily
Duly Health and Care Chicago
Lisle, Illinois, United States
RECRUITINGUrology of Indiana, LLC
Greenwood, Indiana, United States
RECRUITINGFirst Urology
Jeffersonville, Indiana, United States
To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants)
Complete response (CR) rate
Time frame: within 6 months
To assess the efficacy of Dabogratinib in LG UTUC in all participants (proportion of participants with a CR within 6 months out of all LG UTUC participants)
Complete Response (CR) rate
Time frame: at 6 months
Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)
Time frame: up to 36 months
Complete Response (proportion of participants who continue to have a CR at 12 and 24 months)
Time frame: at 12 and 24 months
Safety and tolerability of dabogratinib
Incidence rate and severity of adverse events
Time frame: Up to 2 years
Rate of renal preservation after treatment with dabogratinib
Proportion of participants who did not undergo a nephrectomy or nephroureterectomy
Time frame: Up to 2 years
Change from unresectable UTUC to resectable UTUC
Proportion of participants with unresectable disease at baseline who convert to resectable disease on dabogratinib, as assessed by the Investigator
Time frame: Up to 2 years
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Greater Boston Urology - Plymouth Care Center
Plymouth, Massachusetts, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGUrology Associates, P C
Nashville, Tennessee, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITING