Multicenter Phase III 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

Study Identifier:
CLIN2001-UCM301
CT.gov Identifier:
NCT04620239
EudraCT Identifier:
202000000000
EU Trial (CTIS) Number:
2024-512322-28-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To evaluate the safety and efficacy of TOOKAD (Padeliporfin) vascular targeted photodynamic therapy in the treatment of low grade upper tract urothelial cancer

To evaluate Padeliporfin VTP for the treatment of low-grade UTUC.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Urinary tract
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: TOOKAD VTP
    • Read More
  • Drug: Pts are being treated with padeliporfin VTP in two phases: Induction and Maintenance treatment Phases (ITP and MTP). ITP consists of 1-3 VTPs every 28 days. If CR is not achieved after 1st VTP, up to 2 additional VTPs are allowed. If CR is achieved in the ITP, pts are allowed into the MTP (12 mos). In the MTP VTPs can be provided every 3 mos for pts with recurrent tumor that is deemed treatable, defined as LG with the largest tumor (index) 5 -15 mm, in up to 2 locations in the kidney or one ureter location ≤20 mm. Long Term FU Phase: Pts completing the MTP, will be followed for safety for 48 mos with no VTPs.
  • Drug: ASCO 2023:
  • Drug: Patients are treated in two phases: Induction(ITP) and Maintenance Treatment Phases (MTP). ITP consists of 1-3 VTPs provided at 4-week intervals until achieving complete response (CR) or treatment failure.
  • Drug: The study consists of two parts - an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) - across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months.
  • Drug: CTIS:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Up to 2 biopsy-proven LG UTUC tumors with the largest tumor (index) 5-15 mm, located in the calyces, renal pelvis or in the ureter, with no HG cells. Ureter involvement in one location ≤ 20 mm.
    • 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 (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion
    • Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment
    • Prohibited medication that could not be adjusted or discontinued prior to study treatment
    • Patients with photosensitive skin diseases or porphyria
    • 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 padeliporfin VTP treatment.
    Exclusion criteria
    • Current HG or muscle invasive urothelial bladder cancer. CIS current or previous in the upper urinary tract. History of ≥ T2 urothelial cancer in the past 2 years.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruiting
    Condition(s) Treated at Site
    Urinary tract