Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
Condition: Bladder Carcinoma in Situ (CIS) · Sponsor: Fidia Farmaceutici s.p.a.
About this study
This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in adult patients with histologically and cytologically confirmed CIS, with or without concomitant Ta-T1, who are unresponsive to BCG therapy and unwilling or unfit to undergo radical cystectomy. After providing written informed consent (in presence of an Independent Witness, if applicable), patients will receive an induction therapy consisting of 12 weekly intravesical instillations of ONCOFID-P-B (induction phase). Patients with residual CIS at the end of induction treatment are eligible to enter a re-induction course of therapy (reinduction phase). Patients with stable disease by Investigator assessment defined as neither increased or decreased in extent or severity compared to baseline, are not eligible for re-induction therapy. Patients who achieve a complete resonde (CR) at the end of the induction or re-induction phase enter in the maintenance phase and receive monthly intravesical instillations of ONCOFID-P-B for an additional 12 monsthe or untile recurrence of CIS/HG Ta-T1 or progression to MIBC or extravesical disease. Patients who do not achieve a CR at the end of induction or re-induction phase, will discontinue investigational treatement and are followed up until month 48 from induction or re-induction start, or until a new antitumor therapy is initiated, wichever occurs first. Tumor response is evaluated by cyst…
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (47)
| Banner Health- MD Anderson Cancer Center | Gilbert, Arizona, United States | — |
| Ochsner Clinic Foundation | New Orleans, Louisiana, United States | — |
| Johns Hopkins Kimmel Cancer Center | Baltimore, Maryland, United States | — |
| University of Minnesota | Minneapolis, Minnesota, United States | — |
| TriState Urologic Services PSC Inc. dba The Urology Group | Cincinnati, Ohio, United States | — |
| Medical University of South Carolina (MUSC) | Charleston, South Carolina, United States | — |
| CHU Bordeaux -Hopital Pellegrin | Bordeaux, France | — |
| CHU de Clermont-Ferrand - Hopital Gabriel Montpied | Clermont-Ferrand, France | — |
| CHU de Lille - Hopital Claude Huriez | Lille, France | — |
| Institute Paoli-Calmettes | Marseille, France | — |
| AP-HP Hopital Bichat-Claude Bernard | Paris, France | — |
| AP-HP Hopital Tenon | Paris, France | — |
+ 35 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05024773