Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer
Objective
Primary Objectives; Efficacy: To demonstrate the efficacy and durability of effect following TOOKAD (padeliporfin) VTP on low grade UTUC tumors in the calyces, renal pelvis and ureter.
Secondary Objectives; Safety: To evaluate TOOKAD (padeliporfin) VTP‐related safety and tolerability in the treatment of low grade UTUC tumors in the calyces, renal pelvis and ureter Genomic Markers: To explore a potential link between UTUC cancer genomic markers and treatment related clinical outcomes and disease progression. Pharmacokinetic: To evaluate the pharmacokinetic profile in UTUC patients with moderate hepatic impairment.
