* ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer
Research type
Research Study
Full title
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
IRAS ID
296061
Contact name
Minal Kara
Contact email
Sponsor organisation
Steba biotech, S.A.
Eudract number
2020-004494-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 4 days
Research summary
The purpose of this study is to learn about the effects and safety of an investigational treatment named TOOKAD Vascular Targeted Photodynamic Therapy (VTP), in treating low-grade non-invasive upper tract urothelial cancer. TOOKAD treatment is a two-part process. The study drug is injected into a vein and is then activated at the tumour site through illumination using a laser (VTP). Once activated, the study drug destroys the vessels supplying blood to the cancer, which is thought to cause rapid death of the cancer cells. Because the light is produced by a laser, and delivered with precision, it can be used to treat a specific tissue with limited damage to other tissues. Approximately 100 participants will take part at approximately 30-40 study sites in USA, Europe, and Israel. Participation in this study will last 62-64 months. The completion of the study will include up to 9 study visits to the study site and 2 phone visits. This study will use competitive enrolment. This means that when a target number of participants begins the study, all further enrolment will be closed. Therefore, it is possible that a participant could be in the screening phase, ready to begin the study, and be discontinued without their consent if the target number of participants has already begun the study. This is an open-label study meaning patients, study doctor, study staff, and the Sponsor will know the study medicine and the doses that patients are given. Patients will receive between 1 and 6 doses of TOOKAD VTP. TOOKAD VTP is the only investigational treatment they will receive. There are 4 stages in the study: screening phase, induction treatment phase, maintenance treatment phase and a long-term follow up phase.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0301
Date of REC Opinion
6 Dec 2021
REC opinion
Further Information Favourable Opinion