Universitaetsklinikum Carl Gustav Carus Dresden 01307 Dresden (Sachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Prof. Christian Thomas, MD» Ansprechpartner anzeigenUniversitaetsklinikum Tuebingen 72076 Tübingen (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Steffen Rausch, MD» Ansprechpartner anzeigenUniversity of California - Irvine Medical Center 92868 Irvine United StatesRekrutierend» Google-Maps Ansprechpartner: Edward Uchio, MD» Ansprechpartner anzeigen
Keck School of Medicine at USC Medical Center 90033 Los Angeles United StatesRekrutierend» Google-Maps Ansprechpartner: Hooman Djaladat, MD» Ansprechpartner anzeigenEmory University Hospital 30322 Atlanta United StatesRekrutierend» Google-Maps Ansprechpartner: Kenneth Ogan, MD» Ansprechpartner anzeigenThe Johns Hopkins Hospital, The Sidney Kimmel Cancer Center 21287 Baltimore United StatesRekrutierend» Google-Maps Ansprechpartner: Nirmish Singla, MD» Ansprechpartner anzeigenAlbany Medical College 12208 Albany United StatesRekrutierend» Google-Maps Ansprechpartner: Prof. Ronald Kaufman, MD» Ansprechpartner anzeigenMemorial Sloan Kettering Cancer Center 10065 New York United StatesRekrutierend» Google-Maps Ansprechpartner: Jonathan Coleman, MD
1. Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter (Time Frame - 28 +/- 3 days post last treatment): Primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces renal pelvis and ureter on endoscopic evaluation at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during padeliporfin VTP induction treatment phase. This outcome will be determined dichotomously as either failure or success in achieving complete response.
· Complete Response will be defined as absence of disease based on:
absence of visual tumor on endoscopy
no evidence of tumor on biopsy (if feasible)
negative urinary cytology by instrumented collection
Secondary outcome:
1. Duration of response at the entire ipsilateral kidney (Time Frame - 12 months post PRE): The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, based on:
instrumented cytology
visually on endoscopy
biopsy pathology (if feasible) as will be measured at the 12 months maintenance treatment visit post PRE
2. Duration of response at the entire ipsilateral kidney (Time Frame - 3, 6, 9 months post PRE): The duration of response at the entire ipsilateral kidney will be defined as absence of disease in the entire ipsilateral calyces, renal pelvis and ureter, based on:
instrumented cytology
visually on endoscopy
biopsy pathology (if feasible) as will be measured at the 3, 6, 9 months maintenance treatment visits post PRE
3. Duration of response at the Treatment Area of the ipsilateral kidney (Time Frame - 3, 6, 9, and 12 months post PRE): Duration of response at the Treatment Area of the ipsilateral kidney will be defined as absence of disease in the ipsilateral Treatment Area, based on:
instrumented cytology
visually on endoscopy
biopsy pathology (if feasible) as will be measured at the 3, 6, 9, and 12 months maintenance treatment visits post PRE
4. Overall renal function (Time Frame - 6 and 12 months post PRE): Overall renal functional outcome will be measured at the 6 and 12 months maintenance treatment visits post PRE, and will be evaluated by comparing pre-treatment and 12-month estimated glomerular filtration rate (eGFR), calculated from serum creatinine levels, using the CKD-Epi method including:
Absolute change in eGFR as well as categories of CKD will be utilized based on KDIGO 2012 criteria
Description will include change in eGFR, change in CKD stage/risk category
5. Kidney organ loss or preservation (Time Frame - 3, 6, 9, and 12 months post PRE): Kidney organ loss or preservation will be recorded at each maintenance treatment visit post PRE at 3, 6, 9, and 12 months Maintenance Treatment visits, and will describe the reasons for organ preservation or loss. A radical nephroureterectomy, nephron-sparing surgery for UTUC or ureterectomy will be considered as organ loss.
6. Pathological evaluation of response (Time Frame - After at least one VTP treatment): PathologicalPathological evaluation of response will be performed in kidney tissue of patients that will undergo kidney surgical removal (kidney sparing, or radical nephroureterectomy) following at least one padeliporfin VTP treatment
7. Patients with ureteral obstruction and/or ureteral stent (Time Frame - Baseline 12 months): Patients with existing ureteral obstruction and/or existing ureteral stent will be permitted with radiographic evidence of pre-existing obstruction documented, to demonstrate the site and degree of obstruction with retrograde pyelography at baseline (prior to treatment) and will be repeated and recorded at 12 months maintenance treatment visit (post treatment) which will further be supported with CT Urogram results at 12 months to demonstrate the site and degree of obstruction using standard nomenclature.
8. Long Term follow-up Duration of the response (Time Frame - 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE): The duration of response in the ipsilateral kidney and treatment area will be defined as absence of disease, based on:
instrumented cytology
visually on endoscopy
biopsy pathology (if present and performed)
9. Long Term follow-up Kidney organ loss or preservation (Time Frame - 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE): Kidney organ loss or preservation will be recorded and will describe the reasons for organ preservation or loss. A radical nephroureterectomy, nephron-sparing surgery for UTUC or ureterectomy will be considered as organ loss and a pathology report of the removed tissue will be recorded (if available or feasible)
10. Long Term follow-up Overall renal functional (Time Frame - 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE): Overall renal functional outcome will be evaluated by estimated glomerular filtration rate(eGFR) using CKD-Epimethod
11. Long Term follow-up Safety Follow up (Time Frame - 18, 24,36,48 and 60 months post PRE or 6 and 12 months post PRE): Safety follow up based and recording of adverse events
12. Exploratory Endpoint (Time Frame - Baseline): Blood,tumor and cytology samples will be collected, centrally stored and later submitted for tumor genomic sequencing studies to explore the tumor genomic alterations, and mutation status as biomarkers with association to treatment response and progression events such as recurrence, grade transformation, increased stage and metastases.
13. Pharmacokinetic Endpoint Cmax (Time Frame - 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection): Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate Cmax
14. Pharmacokinetic Endpoint Tmax (Time Frame - 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection): Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate Tmax
15. Pharmacokinetic Endpoint T1/2 (Time Frame - 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection): Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate T1/2
16. Pharmacokinetic Endpoint AUC (Time Frame - 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection): Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate AUC
17. Pharmacokinetic Endpoint CL (Time Frame - 0 (before injection) and 20, 40, 60, 90, 120 and 360 mn after end of injection): Patients with moderate hepatic impairment, will undergo a pharmacokinetic evaluation, blood samples will be collected to evaluate CL
padeliporfin VTP (WST11): 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.
Quelle: ClinicalTrials.gov
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"ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study"
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