Bladder Cancer Clinical Trial

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)

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 who achieve a CR by Investigator assessment at the end of the induction phase will enter the maintenance phase and receive monthly treatment for an additional 12 months or until recurrence of CIS/Ta-T1 or progression to MIBC or extravesical disease.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Willing and able to freely provide written informed consent (in presence of an Independent Witness if applicable) prior to performing study procedures.
Age 18 years or older, male or female.
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.

"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.

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).

In patients with T1 papillary lesions undergoing resection of the base of the lesion, the biopsy should contain muscle fibers.
In patients undergoing transurethal resection of their bladder tumors, absence of locally advanced disease should be confirmed by pelvic examination under anesthesia.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Adequate organ function: absolute neutrophil count ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10.0 g/dL, ALT/AST ≤1. 5 x upper limit of normal (ULN), alkaline phosphatase ≤ 5 x ULN, total serum bilirubin ≤ 1.5 x ULN, serum creatinine ≤ 2.2 mg/dL.

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 (**)

Male patients with WOCBP partners must agree to use effective contraceptive methods, i.e.:

condom;
consider contraception for non-pregnant WOCBP partner.
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:

Current or previous muscle-invasive disease (T2-T4) or metastatic urothelial carcinoma.
Suspected hypersensitivity to paclitaxel or to any of the Oncofid-P-B constituents.
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.
Current or prior systemic therapy for bladder cancer.
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.
Symptomatic urinary tract infection or bacterial cystitis. Once successfully treated (negative urine culture), patients may enter the study.
Major surgery, other than diagnostic, within 4 weeks prior to treatment.
Previous (within the last 5 years) or current malignancies at other sites, except for 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.
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).
Presence of significant urologic disease interfering with intravesical therapy.
Current enrollment or participation in another therapeutic clinical trial within 6 months preceding treatment start. 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.
Known substance and/or alcohol abuse.
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.
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.
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.

Subjects who have a mean QTc >480 msec at baseline and who need concomitant medications which may cause QT prolongation.

Applies to France Only:

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.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

112

Study ID:

NCT05024773

Recruitment Status:

Recruiting

Sponsor:

Fidia Farmaceutici s.p.a.

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There are 24 Locations for this study

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Banner Health- MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Joseph Mashni, MD
Contact
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States More Info
Stephen Bardot, MD
Contact
Johns Hopkins Kimmel Cancer Center
Baltimore Maryland, 21287, United States More Info
Max Kates, MD
Contact
University of Minnesota
Minneapolis Minnesota, 55455, United States More Info
Hamed Ahmadi, MD
Contact
Medical University of South Carolina (MUSC)
Charleston South Carolina, 29425, United States More Info
Stephen J Savage, MD
Contact
CHU de Clermont-Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand Auvergne-Rhone-Alpes, 63000, France More Info
Laurent Guy, MD
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CHU Bordeaux -Hopital Pellegrin
Bordeaux , 33000, France More Info
Gregoire Robert, MD
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CHU de Lille - Hopital Claude Huriez
Lille , , France More Info
Gautier Marcq, MD
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Institute Paoli-Calmettes
Marseille , 13009, France More Info
Pignot Geraldine, MD
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AP-HP Hopital Tenon
Paris , 75020, France More Info
Olivier Traxer, MD
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AP-HP Hopital Bichat-Claude Bernard
Paris , , France More Info
Evanguelos Xylinas, MD
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Centre Hospitalier Universitaire Poitiers
Poitiers , 86000, France More Info
Simon Bernardeu, MD
Contact
Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo
Castelfranco Veneto Padova, 31033, Italy More Info
Angelo Porreca, MD
Contact
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna , , Italy More Info
Francesco Chessa, MD
Contact
Azienda Ospedaliero-Universitaria Careggi
Firenze , 50134, Italy More Info
Mauro Gacci, MD
Contact
IRCSS Ospedale San Raffaele
Milano , 20132, Italy More Info
Marco Moschini, MD
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy More Info
Alberto Macchi, MD
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Istituto Clinico Humanitas
Milano , , Italy More Info
Rodolfo Hurle, MD
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AOU Città della Salute e della Scienza di Torino-Ospedale le Molinette
Torino , 10126, Italy More Info
Francesco Soria, MD
Contact
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
Verona , 37126, Italy More Info
Alessandro Antonelli, MD
Contact
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Oddzial Urologiczny
Lublin , 20-09, Poland More Info
Robert Klijer, MD
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Wojewodzki Szpital im Sw. Ojca Pio w Przemyslu, Oddzial Urologiczny z Pododdzialem Urologii Onkologicznej
Przemyśl , 37-70, Poland More Info
Rafał Walczak, MD
Contact
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warszawa , 02-63, Poland More Info
Tomasz Szopinski, MD
Contact
Hospital Universitario de Basurto
Bilbao Bizkaia, 48013, Spain More Info
Ainara Rabade Ferreiro, MD
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Vall d'Hebron Barcelona Hospital
Barcelona , 08035, Spain More Info
Carlos Xavier Raventós Busquets, MD
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Hospital Universitari de Bellvitge
Barcelona , 08907, Spain More Info
Francesc Vigues, MD
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Hospital Clinic Barcelona
Barcelona , , Spain More Info
Ribal Caparros, MD
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Hospital Universitario Reina Sofia
Córdoba , , Spain More Info
Garcia Rubio Jose Horacio, MD
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Hospital Universitario Virgen de las Nieves
Granada , 18014, Spain More Info
Fernando Vàzquez Alonso, MD
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Centro Integral Oncologico Clara Campal
Madrid , , Spain More Info
Felix Guerrero Ramos, MD
Contact
Hospital Fundación Jimenez Diaz
Madrid , , Spain More Info
Juan Ignacio Monzo Gardiner, MD
Contact
Hospital Universitario Fundacion Alcorcon
Madrid , , Spain More Info
Carlos Llorente, MD
Contact
Hospital Universitario Virgen de la Victoria
Malaga , , Spain More Info
Felipe Sáez Barranquero, MD
Contact
Instituto Valenciano de Oncologia
Valencia , 46009, Spain More Info
Jose L Dominguez-Escrig, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

112

Study ID:

NCT05024773

Recruitment Status:

Recruiting

Sponsor:


Fidia Farmaceutici s.p.a.

How clear is this clinincal trial information?

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