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NCT05024773 · ClinicalTrials.gov registry record · Phase 3
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
A Phase 3 study of Bladder Carcinoma in Situ (CIS), sponsored by Fidia Farmaceutici s.p.a..
- Recruiting
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
- 20
- Study locations
NCT05024773 is a Phase 3 study of Bladder Carcinoma in Situ (CIS) that is actively recruiting participants, run by Fidia Farmaceutici s.p.a.. The registered enrollment target is 112 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT05024773, a Phase 3 study of Bladder Carcinoma in Situ (CIS), is actively recruiting participants, sponsored by Fidia Farmaceutici s.p.a..
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 cystoscopy, cytology and biopsy at the end of the induction and re-induction phases and at Safety Follow Up Visit (SFUV). During the maintenance/follow-up period, tumorresponse is evaluated by cystoscopy and cytology every 3 months for up to 24 months from induction or re-induction start, and then every 6 months for an additional 2 years (long-term follow-up). Tumor biopsies are performed in case of of positive cystoscopy and/or cytology. Random biopsies are to be performed at 6, 12 and 18 months af
Conditions Studied
Interventions
- DRUG ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Study Locations (20)
Other
- CHU Bordeaux -Hopital Pellegrin - Bordeaux
- CHU de Clermont-Ferrand - Hopital Gabriel Montpied - Clermont-Ferrand
- CHU de Lille - Hopital Claude Huriez - Lille
- Institute Paoli-Calmettes - Marseille
- AP-HP Hopital Bichat-Claude Bernard - Paris
- AP-HP Hopital Tenon - Paris
- Centre Hospitalier Universitaire Poitiers - Poitiers
- Humanitas Gavazzeni - Bergamo
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola - Bologna
- Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo - Castelfranco Veneto
- Azienda Ospedaliero-Universitaria Careggi - Florence
- ASL Lecce- Ospedale Vito Fazzi - Lecce
- Istituto Clinico Humanitas - Milan
- IRCSS Ospedale San Raffaele - Milan
Arizona
- Banner Health- MD Anderson Cancer Center - Gilbert
Louisiana
- Ochsner Clinic Foundation - New Orleans
Maryland
- Johns Hopkins Kimmel Cancer Center - Baltimore
Minnesota
- University of Minnesota - Minneapolis
Ohio
- TriState Urologic Services PSC Inc. dba The Urology Group - Cincinnati
South Carolina
- Medical University of South Carolina (MUSC) - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2022-12-29 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05024773
The ClinicalTrials.gov registry entry for NCT05024773 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fidia Farmaceutici s.p.a., which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bladder Carcinoma in Situ (CIS) appearing as the primary indexed condition, and to 1 intervention - of which ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) is the first listed.
NCT05024773 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Arizona, Louisiana.
Frequently Asked Questions
What is clinical trial NCT05024773 about?
NCT05024773 is a clinical study titled "Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)". 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 unw...
What is the current status of trial NCT05024773?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2022-12-29. Estimated completion is 2027-11.
What conditions does trial NCT05024773 study?
This clinical trial studies the following conditions: Bladder Carcinoma in Situ (CIS).
What interventions are being tested in trial NCT05024773?
The interventions under investigation include: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) (DRUG).
Who is sponsoring clinical trial NCT05024773?
This trial is sponsored by Fidia Farmaceutici s.p.a., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05024773 being conducted?
This trial has 20 study locations across Arizona, Louisiana, Maryland, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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