Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant

PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

October 2, 2023

Primary Completion Date

January 1, 2027

Study Completion Date

January 1, 2032

Conditions
Urothelial Carcinoma BladderAndrogen Receptor Positive
Interventions
DRUG

Degarelix

initial dose is 240 mg administered as two 120 mg (3 mL) injections (SC), followed by subsequent doses at 80 mg (4 mL) administered as one injection (SC)

COMBINATION_PRODUCT

Gemcitabine/Cisplatin

"SOC Neoadjuvant Chemotherapy: Gemcitabine/Cisplatin 21-day cycles (4 cycles total)~* Gemcitabine: 1000 mg/m2 (IV) Days 1 and 8 of each cycle~* Cisplatin: 70 mg/m2 (if borderline renal function: 35 mg/m2) (IV) Day 1 of each cycle (if borderline renal function, days 1 and 8 of each cycle)."

Trial Locations (1)

02912

RECRUITING

Lifespan Cancer Institute, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Legorreta Cancer Center at Brown University

UNKNOWN

collaborator

Lifespan

OTHER

collaborator

Cures Within Reach

OTHER

lead

Brown University

OTHER

NCT05839119 - Targeting Androgen Signaling in Urothelial Cell Carcinoma - Neoadjuvant | Biotech Hunter | Biotech Hunter