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

Condition: Transitional Cell Cancer of Renal Pelvis and Ureter

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04620239

Sponsor: Steba Biotech S.A.

Phase: Phase 3

Eligibility:

Inclusion Criteria:

Male and female patients 18 years or older
Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
New or recurrent low-grade, non-invasive UTUC disease
Biopsy-proven disease . A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (measured by endoscopy), both located in the calyces,renal pelvis or in the ureter of the ipsilateral kidney, with an absence of high-grade cells on cytology. (Ureter involvement should be in one anatomical location with no more than 20 mm of contiguous ureteral length)
Karnofsky Performance Status ≥ 50%
Adequate organ function defined at baseline as:
ANC ≥1,000/ μl,
Platelets ≥75,000/ μl, Hb ≥9 g/dl,
INR ≤ 2
Estimated glomerular giltration rate (eGFR) ≥30 ml/min (using CKD-EPI Method
Total serum bilirubin <3 mg/dL, AST/ALT ≤5× upper limit of normal

Exclusion Criteria:

Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
Systemic chemotherapy treatment within 2 months prior to enrollment
Prohibited medication that could not be adjusted or discontinued prior to study treatment
Any other medical or psychiatric co-morbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary or liver disease or current heavy smoker that, in the opinion of the study investigator, would make the patient a poor candidate for the study
Pregnant or breast-feeding women.Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry.
Men and women of reproductive potential not willing to observe conventional and effective birth control for the duration of treatment and for 90 days following the last TOOKAD VTP treatment.