This is a study that will evaluate the safety and efficacy of TOOKAD® (padeliporfin) Vascular Targeted Photodynamic Therapy (VTP) in the Treatment of Low-Grade Upper Tract Urothelial Cancer (UTUC).

Phase 1

• Conditions: ow Grade Upper Tract Urothelial Cancer; MedDRA version: 21.1Level: LLTClassification code 10077840Term: Urothelial cancer of renal pelvisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10046375Term: Ureter cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004494-41-AT
• Lead Sponsor: Steba biotech, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-07
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Male and female patients 18 years or older
2.Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study
3.New or recurrent low-grade, non-invasive UTUC disease
4.Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
5.Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (as measured by endoscopy), both located in the calyces, renal pelvis or in the ureter of 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).
6.Karnofsky Performance Status = 50%
7.Adequate organ function defined at baseline as:
?ANC =1,000/ µl,
?Platelets =75,000/ µl, Hb =9 g/dl,
?INR =2
?Estimated glomerular filtration rate eGFR =30 ml/min using CKD-EPI Method
?Total serum bilirubin <3 mg/dL, AST/ALT =5× upper limit of normal

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1.Current high-grade or muscle invasive (>pT1) urothelial carcinoma of the bladder
2.Carcinoma in situ (CIS) current or previous in the upper urinary tract
3.History of invasive T2 or higher urothelial cancer in past 2 years
4.Participation in another clinical study involving an investigational product within 1 month before study entry
5.BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion
6.Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment
7.Prohibited medication that could not be adjusted or discontinued prior to study treatment
8. Patients with photosensitive skin diseases or porphyria
9.Any other medical or psychiatric co-morbidities, including decompensated heart failure, unstable angina or coronary artery disease, 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
10.Pregnant or breast-feeding women
Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry.
11.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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified