Actively Recruiting
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
Led by Fidia Farmaceutici s.p.a. · Updated on 2025-12-16
112
Participants Needed
47
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 after the end of the induction or re-induction phase in responding patients (i.e. at 9, 15 and 21 months after induction or re-induction start.
CONDITIONS
Official Title
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent before study procedures
- Age 18 years or older, any gender
- Histologically confirmed persistent or recurrent carcinoma in situ (CIS) of the bladder, with or without recurrent high-grade Ta-T1 tumors, no metastases on CT or MRI
- BCG unresponsive patients who refuse or are not suitable for radical cystectomy
- Adequate prior BCG therapy defined as at least five of six doses of initial induction plus at least two of three maintenance doses, or five of six induction plus two of six second induction doses
- Complete resection of Ta-T1 papillary lesions before entering trial if present
- ECOG performance status of 0, 1, or 2
- Adequate organ function including neutrophils ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥8.5 g/dL, liver enzymes ≤1.5x upper limit normal, alkaline phosphatase ≤5x ULN, bilirubin ≤1.5x ULN (or ≤3x ULN if Gilbert's syndrome), and serum creatinine ≤2.2 mg/dL
- Women in non-reproductive years or women of childbearing potential with negative pregnancy test and agreement to use highly effective contraception
- Male patients with partners who are women of childbearing potential must agree to use effective contraception
- Able and willing to comply with study visits, treatment plans, and laboratory tests
You will not qualify if you...
- Current or previous muscle-invasive (T2-T4) or metastatic urothelial carcinoma
- More than 12 months between last BCG instillation and study inclusion
- Known allergy or hypersensitivity to paclitaxel or any component of ONCOFID-P-B
- Previous or current cancer of the upper urinary tract or prostatic urethra
- Prior systemic therapy for bladder cancer
- Intravesical therapy within 4 weeks before study treatment except certain cytotoxic agents given as single instillation after TURBT within 14-60 days
- Active symptomatic urinary tract infection or bacterial cystitis
- Major surgery within 4 weeks before treatment
- Unstable previous or concurrent malignancies requiring treatment
- Serious comorbid conditions preventing intravesical treatment or procedures
- Significant urologic disease interfering with intravesical therapy
- Participation in another therapeutic clinical trial within 6 months before screening
- Substance or alcohol abuse
- Other serious medical or psychiatric conditions increasing risk or interfering with study
- Pregnancy, breastfeeding, or unwillingness to use adequate birth control
- Male patients with partners unwilling to use contraception during and after study
- QTc interval >480 msec at baseline requiring QT-prolonging medications
- (France only) Persons deprived of liberty or under legal protection measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
Banner Health- MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70124
Actively Recruiting
3
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
TriState Urologic Services PSC Inc. dba The Urology Group
Cincinnati, Ohio, United States, 45212
Actively Recruiting
6
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
7
CHU Bordeaux -Hopital Pellegrin
Bordeaux, France, 33000
Actively Recruiting
8
CHU de Clermont-Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, France, 63000
Actively Recruiting
9
CHU de Lille - Hopital Claude Huriez
Lille, France, 59000
Actively Recruiting
10
Institute Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
11
AP-HP Hopital Bichat-Claude Bernard
Paris, France, 75018
Actively Recruiting
12
AP-HP Hopital Tenon
Paris, France, 75020
Terminated
13
Centre Hospitalier Universitaire Poitiers
Poitiers, France, 90577
Actively Recruiting
14
Humanitas Gavazzeni
Bergamo, Italy, 24125
Actively Recruiting
15
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
16
Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo
Castelfranco Veneto, Italy, 31033
Actively Recruiting
17
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
18
ASL Lecce- Ospedale Vito Fazzi
Lecce, Italy, 73100
Actively Recruiting
19
Istituto Clinico Humanitas
Milan, Italy, 20089
Actively Recruiting
20
IRCSS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
21
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
22
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
23
IFO-Istituto Nazionale dei Tumori Regina Elena
Roma, Italy, 00128
Actively Recruiting
24
AOU Città della Salute e della Scienza di Torino-Ospedale le Molinette
Torino, Italy, 10126
Actively Recruiting
25
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
Verona, Italy, 37126
Actively Recruiting
26
Wojewodzki Szpital im Sw. Ojca Pio w Przemyslu, Oddzial Urologiczny z Pododdzialem Urologii Onkologicznej
Przemyśl, Poland, Poland, 37-700
Actively Recruiting
27
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, Warszawa, Poland, 02-637
Terminated
28
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Oddzial Urologiczny
Lublin, Poland, 20-090
Terminated
29
Vall d'Hebron Barcelona Hospital
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
30
Hospital Universitari de Bellvitge
Barcelona, Barcelona, Spain, 08907
Actively Recruiting
31
Instituto Valenciano de Oncologia
Valencia, Valencia, Spain, 46009
Actively Recruiting
32
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Actively Recruiting
33
Hospital Universitario de Basurto
Bilbao, Spain, 48013
Actively Recruiting
34
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
35
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Actively Recruiting
36
Hospital Fundación Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
37
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
38
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Actively Recruiting
39
Hospital Universitario Fundacion Alcorcon
Madrid, Spain, 28922
Terminated
40
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
41
Darent Valley Hospital
Dartford, Kent, United Kingdom, DA2 8DA
Actively Recruiting
42
Huddersfield Royal Infirmary
Huddersfield, United Kingdom, HD3 3EA
Actively Recruiting
43
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
44
Barts Health NHS Trust
London, United Kingdom, EC1A7BE
Actively Recruiting
45
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
46
Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Actively Recruiting
47
Royal Marsden Hospital - Surrey
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
N
Nicola Giordan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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