Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
112 participants
INTERVENTIONAL
2022-12-29
2027-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Schedule: once a week for 12 consecutive weeks (induction phase). Patients who achieve a complete response at the end of the induction phase will enter the maintenance phase, during which ONCOFID-P-B is administered once a month for 12 months until recurrence or progression of the disease.
Interventions
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ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)
Schedule: once a week for 12 consecutive weeks (induction phase). Patients who achieve a complete response at the end of the induction phase will enter the maintenance phase, during which ONCOFID-P-B is administered once a month for 12 months until recurrence or progression of the disease.
Eligibility Criteria
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Inclusion Criteria
2. Age 18 years or older, male or female.
3. Persistent or recurrent histologically confirmed CIS of the bladder with or without concomitant recurrent HG Ta-T1 and with no evidence of metastases demonstrated by abdominal CT scan or MRI.
4. "BCG unresponsive" patients who refuse radical cystectomy or are not clinically suitable for cystectomy. BCG unresponsive disease is defined as persistent or recurrent CIS alone or with recurrent HG Ta-T1 within 12 months of completion of adequate BCG therapy.
Adequate BCG therapy is defined as at least one of the following:
* At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy.
* At least five of six doses of an initial induction course plus at least two of six doses of a second induction course.
5. Complete resection of Ta-T1 papillary lesions before entering the trial in patients with concomitant CIS and papillary tumors (residual CIS acceptable, obvious areas of CIS should also be fulgurated).
1. In patients with T1 papillary lesions undergoing resection of the base of the lesion, the biopsy should contain muscle fibers.
2. In patients undergoing transurethal resection of their bladder tumors, absence of locally advanced disease should be confirmed by pelvic examination under anesthesia.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
7. Adequate organ function:
* absolute neutrophil count ≥ 1,500/mm3,
* platelets ≥ 100,000/mm3,
* hemoglobin ≥ 8.5 g/dL,
* ALT/AST ≤1. 5 x upper limit of normal (ULN),
* alkaline phosphatase ≤ 5 x ULN,
* total serum bilirubin ≤ 1.5 x ULN, for patients with Gilbert's ≤ 3 X ULN,
* serum creatinine ≤ 2.2 mg/dL.
8. Women in non-reproductive years (defined as surgically sterile or one year postmenopausal). Women of childbearing potential (WOCBP) must have a negative serum pregnancy test upon entry into this study and agree to use highly effective contraceptive methods, i.e. methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include:
* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
* oral
* intravaginal
* transdermal
* progestogen-only hormonal contraception associated with inhibition of ovulation:
* oral
* injectable
* implantable
* intrauterine device (IUD)
* intrauterine hormone-releasing system (IUS)
* bilateral tubal occlusion
* vasectomised partner (\*)
* sexual abstinence (\*\*)
9. Male patients with WOCBP partners must agree to use effective contraceptive methods, i.e.:
* condom;
* consider contraception for non-pregnant WOCBP partner.
10. Able and willing to comply with the scheduled visits, therapy plans, and laboratory tests required in this protocol.
(\*) Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success.
(\*\*) Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated to the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
Exclusion Criteria
2. Patients with more than 12 months between inclusion and the last BCG instillation
3. Suspected hypersensitivity to paclitaxel or to any of the Oncofid-P-B constituents.
4. Previous or concomitant cancer of the upper urinary tract or the prostatic urethra. Freedom from upper tract disease must be demonstrated by intravenous pyelogram, retrograde pyelogram, CT scan or MRI.
5. Current or prior systemic therapy for bladder cancer.
6. Intravesical therapy within 4 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g. mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure between 14 to 60 days prior to beginning study treatment.
7. Symptomatic urinary tract infection or bacterial cystitis. Once successfully treated (negative urine culture), patients may enter the study.
8. Major surgery, other than diagnostic, within 4 weeks prior to treatment.
9. Patients who have previous or concurrent malignancies that require treatment and are not clinically stable; examples of permitted concurrent recent second malignancies are: adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix or prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) \<10 ng/dL, Gleason score 6 or less and cT1.
10. Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders).
11. Presence of significant urologic disease interfering with intravesical therapy.
12. Current enrollment or participation in another therapeutic clinical trial within 6 months preceding screening. Patients previously included in a BCG-only study arm might be enrolled following discussion with the medical monitor and/or sponsor if the definition of adequate BCG therapy is met.
13. Known substance and/or alcohol abuse.
14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry in this study or could compromise protocol objectives.
15. Pregnancy, lactating women or women of childbearing potential (WOCBP) unwilling to use adequate birth control measures for the duration of the study and until 3 months after the end of treatment.
16. Male patients with WOCBP partners unwilling to use contraceptive methods for the duration of the study and until 6 months after the end of treatment.
17. Subjects who have a mean QTc \>480 msec at baseline and who need concomitant medications which may cause QT prolongation.
Applies to France Only:
18. Persons deprived of liberty by judical or administrative decision, adults subjects to a legal protection measure (under guardianship/curators), persons under protective measures and persons not affiliated with social security will be excluded from the study.
18 Years
ALL
No
Sponsors
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Fidia Farmaceutici s.p.a.
INDUSTRY
Responsible Party
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Locations
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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
Centre Hospitalier Universitaire Poitiers
Poitiers, , France
Humanitas Gavazzeni
Bergamo, , Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, , Italy
Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo
Castelfranco Veneto, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
ASL Lecce- Ospedale Vito Fazzi
Lecce, , Italy
Istituto Clinico Humanitas
Milan, , Italy
IRCSS Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , Italy
IFO-Istituto Nazionale dei Tumori Regina Elena
Roma, , Italy
AOU Città della Salute e della Scienza di Torino-Ospedale le Molinette
Torino, , Italy
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
Verona, , Italy
Wojewodzki Szpital im Sw. Ojca Pio w Przemyslu, Oddzial Urologiczny z Pododdzialem Urologii Onkologicznej
Przemyśl, Poland, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, Warszawa, Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Oddzial Urologiczny
Lublin, , Poland
Vall d'Hebron Barcelona Hospital
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Barcelona, Spain
Instituto Valenciano de Oncologia
Valencia, Valencia, Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Universitario de Basurto
Bilbao, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Fundación Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Universitario Fundacion Alcorcon
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Darent Valley Hospital
Dartford, Kent, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Royal Marsden Hospital - Surrey
Sutton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Joseph Mashni, MD
Role: primary
Stephen Bardot, MD
Role: primary
Max Kates, MD
Role: primary
Hamed Ahmadi, MD
Role: primary
Marc Pliskin, MD
Role: primary
Stephen J Savage, MD
Role: primary
Gregoire Robert, MD
Role: primary
Laurent Guy, MD
Role: primary
Gautier Marcq, MD
Role: primary
Geraldine Pignot, MD
Role: primary
Evanguelos Xylinas, MD
Role: primary
Simon Bernardeu, MD
Role: primary
Angelo Porreca, MD
Role: primary
Francesco Chessa, MD
Role: primary
Antonio Amodeo, MD
Role: primary
Mauro Gacci, MD
Role: primary
Vincenzo Pagliarulo, MD
Role: primary
Rodolfo Hurle, MD
Role: primary
Marco Moschini, MD
Role: primary
Alberto Macchi, MD
Role: primary
Rosa Tambaro, MD
Role: primary
Giuseppe Simone
Role: primary
Francesco Soria, MD
Role: primary
Alessandro Antonelli, MD
Role: primary
Rafał Walczak, MD
Role: primary
Carlos Xavier Raventós Busquets, MD
Role: primary
Francesc Vigues, MD
Role: primary
Jose L Dominguez-Escrig, MD
Role: primary
Ribal Caparros, MD
Role: primary
Ainara Rabade Ferreiro, MD
Role: primary
Garcia Rubio Jose Horacio, MD
Role: primary
Fernando Vàzquez Alonso, MD
Role: primary
Juan Ignacio Monzo Gardiner, MD
Role: primary
Ramos Guerrero, MD
Role: primary
Felix Guerrero Ramos, MD
Role: primary
Felipe Sáez Barranquero, MD
Role: primary
Sanjeev Madaan, MD
Role: primary
Tahir Qayyum, MD
Role: primary
Sanjeev Kotwal, MD
Role: primary
Bernadett Szabados, MD
Role: primary
Paul Hunter-Campbell, MD
Role: primary
Michal Smolski, MD
Role: primary
Pardeep Kumar, MD
Role: primary
Other Identifiers
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R39_21_01
Identifier Type: -
Identifier Source: org_study_id