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
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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Plymouth, Massachusetts, United States
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Ann Arbor, Michigan, United States
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RECRUITING...and 16 more locations