ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study
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
Steba Biotech S.A.
100 participants
Mar 22, 2021
INTERVENTIONAL
Conditions
Summary
This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment
Eligibility
Inclusion Criteria12
- 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 (as 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 Criteria11
- 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.
Interventions
During treatment, placement at the target area of an optical light fiber, through the working channel of the ureteroscope. Intravenous administration of padeliporfin at the dose of 3.66 mg/kg infused over 10 minutes. Each target area will be illuminated for 10 minutes.
Locations(18)
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NCT04620239