Clinical Trials Register

Summary
EudraCT Number:	2016-003813-92
Sponsor's Protocol Code Number:	EPT02/2016
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-02-22
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-003813-92

A.3

Full title of the trial

Open clinical trial to evaluate the efficacy of intravesical instillation of hyaluronate added to early instillation of mitomycin vs early instillation of mitomycin in patients suffering from low risk not muscle-infiltrating bladder cancer

Studio clinico in aperto per valutare l’efficacia dell’instillazione endovescicale in add-on di acido ialuronico/condroitin solfato dopo instillazione precoce di mitomicina C vs l’instillazione precoce di mitomicina C in pazienti affetti da neoplasia vescicale non muscolo infiltrante a basso rischio

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Addition of hyaluronate to mitomycin vs mitomycin in low risk bladder cancer

Aggiunta di acido ialuronico a mitomicina vs mitomicina nel cancro della vescica a basso rischio

A.3.2

Name or abbreviated title of the trial where available

Efficacy of hyaluronate/condroitinsolfate (Ialuril Prefill) added on top of Mitomycin C vs Mitomy

Efficacia di Acidio ialuronico/condrotinsolfato (Ialuril Prefill) aggiunto a Mitomicina C vs Mito

A.4.1

Sponsor's protocol code number

EPT02/2016

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	IBSA FARMACEUTICI ITALIA SRL
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	IBSA FARMACEUTICI ITALIA SRL
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	InformaPRO Srl
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Via Luigi Rava, 43
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00149
B.5.3.4	Country	Italy
B.5.4	Telephone number	065758926
B.5.5	Fax number	0662207168
B.5.6	E-mail	segreteria@informa.pro

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	MITOMYCIN C
D.2.1.1.2	Name of the Marketing Authorisation holder	PROSTRAKAN LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Low risk not muscle-infiltrating bladder neoplasia

Neoplasia vescicale non muscolo infiltrante a basso rischio

E.1.1.1

Medical condition in easily understood language

Bladder cancer not diffundet to muscular wall of the bladder, defined as low risk cancer according to guidelines

Cancro della vescica non diffuso alla parete muscolare della vescica, definito a basso rischio secondo le linee guida

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10005005
E.1.2	Term	Bladder cancer recurrent
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of the efficacy, in terms of absence of relapse, of the intravesical instillation of hyaluronate/condroitinsolfate as add-on within 12 hours from early intravesical instillation of Mitomycin C vs early instillation of Mitomycin C in monotherapy within 24 hours from endoscopic resection,in the therapy of not muscle-infiltrating bladder cancer, in patients with low risk according to EORTC.

Valutazione della efficacia, in termini di assenza di recidiva, della instillazione endovescicale in add-on di Acido Ialuronico/Condroitin Solfato (Ialuril Prefill) entro 12 ore dall’instillazione precoce di Mitomicina C (Mitomycin C) vs l’instillazione precoce endovescicale di Mitomicina C (Mitomycin C) in monoterapia, entro 24 ore dalla resezione endoscopica, nella terapia della neoplasia vescicale non muscolo infiltrante, in pazienti con classe di rischio basso secondo EORTC.

E.2.2

Secondary objectives of the trial

Evaluation of the efficacy, in terms of free time of disease, time of relapse and rate of progression , of the intravesical instillation of hyaluronate/condroitinsolfate as add-on within 12 hours from early intravesical instillation of Mitomycin C vs early instillation of Mitomycin C in monotherapy, in the therapy of not muscle-infiltrating bladder cancer, in patients with low risk acording to EORTC.

Valutazione della efficacia, in termini di tempo libero da malattia, tempo di recidiva e tasso di progressione, e della sicurezza della instillazione endovescicale in add-on di acido ialuronico/condroitin solfato (Ialuril Prefill) entro 12 ore dall’instillazione precoce di mitomicina C (Mitomycin C) vs l’instillazione precoce endovescicale di mitomicina C (Mitomycin C) in monoterapia, entro 24 ore dalla resezione endoscopica, nella terapia della neoplasia vescicale non muscolo infiltrante, in pazienti con classe di rischio basso secondo EORTC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Both gender with 18-80 years of age
Physiological/Surgical Menopause
Histological diagnosis of transitional vesical neoplasia
Patients with vesical neoplasia at low risk according to EORTC
Written informed consent

• Pazienti di sesso maschile/femminile con un’età compresa tra 18-80 anni;
• Menopausa fisiologica/chirurgica
• Diagnosi istologica di neoplasia vescicale transizionale
• Pazienti con neoplasia vescicale a rischio basso secondo classi di rischio EORTC
• Consenso scritto informato

E.4

Principal exclusion criteria

Hypersensitivity either to Ialurill Prefill or to one of its component
Hypersensitivity and controindications to Mitomycin C
Ongoing macroematuria
Suspected bladder drill
Patients with vesical neoplasia at high risk according to EORTC
Capacity of bladder < 300 cc

• Ipersensibilità allo Ialuril Prefill o a uno dei suoi componenti
• Ipersensibilità e controindicazioni a Mitoyicin C
• Macroematuria in atto
• Sospetta perforazione vescicale
• Pazienti con neoplasia vescicale ad alto rischio secondo le classi di rischio EORTC
• Capacità vescicale < 300 cc

E.5 End points

E.5.1

Primary end point(s)

Evaluation of number and porcentage of patients that show absence of relapse after 24 months from the add on intravesical administration of hyaluronate/condrotinsolfate aftter early intravesical instillation of Mitomycin C vs intravesical instillation of Mitomycin C in monotherapy

• Valutazione del numero e della percentuale di pazienti che mostrano assenza di recidiva dopo 24 mesi dalla somministrazione endovescicale in add-on di Ialuril Prefill dopo instillazione endovescicale precoce di Mitomycin C vs la somministrazione endovescicale precoce di Mitomycin C.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 months

24 mesi

E.5.2

Secondary end point(s)

Evaluation of number and porcentage of patients that show absence of relapse after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C
Evaluation of free time from disease after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C
Evaluation of time of relapse after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C
Evaluation of time of progression after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C
Evaluation of rate and entity of adverse events and incidents after 3, 9 and 15 months from the add on intravesical administration of Ialuril Prefill after early intravesical instillation of Mitomycin C vs early intravesical administration of Mitomycin C

• Valutazione del numero e della percentuale di pazienti che mostra assenza di recidiva dopo 3, 9 e 15 mesi dalla somministrazione endovescicale in add-on di Ialuril Prefill dopo instillazione endovescicale precoce di Mitomycin C vs la somministrazione endovescicale precoce di Mitomycin C.
• Valutazione del tempo libero da malattia dopo 3, 9, 15, e 24 mesi dalla somministrazione endovescicale in add-on di Ialuril Prefill dopo instillazione endovescicale precoce di Mitomycin C vs la somministrazione endovescicale precoce di Mitomycin C.
• Valutazione del tempo di recidiva dopo 3, 9, 15 e 24 mesi dalla somministrazione endovescicale in add-on di Ialuril Prefill dopo instillazione endovescicale precoce di Mitomycin C vs la somministrazione endovescicale precoce di Mitomycin C.
• Valutazione del tasso di progressione dopo 3, 9, 15 e 24 mesi dalla somministrazione endovescicale in add-on di Ialuril Prefill dopo instillazione endovescicale precoce di Mitomycin C vs la somministrazione endovescicale precoce di Mitomycin C.
• Valutazione del tasso e dell’entità degli eventi avversi e degli incidenti dopo 3, 9, 15 e 24 mesi dalla somministrazione endovescicale in add-on di Ialuril Prefill dopo instillazione endovescicale precoce di Mitomycin C vs la somministrazione endovescicale precoce di Mitomycin C.

E.5.2.1

Timepoint(s) of evaluation of this end point

3, 9, 15 months or absence of relapse
3, 9, 15 and 24 months for free time from disease, time of relapse, time of progression, rate/entity of AEs/incident

3, 9, 15 mesi per assenza di recidiva
3, 9, 15, e 24 mesi per tempo libero da malattia, tempo di recidiva, tempo di progressione, indice/entità di eventi avversi/incidenti

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

In un gruppo, a Mitomycin C C viene aggiunto Ialuril Prefill (dispositivo medico)

In one group, Ialrull Prefill (medical device) is added to mItomycin C

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

120

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

Information not present in EudraCT

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

Information not present in EudraCT

F.3.3.6

Subjects incapable of giving consent personally

Information not present in EudraCT

F.3.3.7

Others

Information not present in EudraCT

F.4 Planned number of subjects to be included

F.4.1

In the member state

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

120

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will be evaluated during a period of 24 months after the single intravesical administration of active treatment which is either Ialuril Prefill on top of mitomycin C or mitomycin C in monotherapy, according to the two treatment groups which patients are assigned to. Therefore the period of 24 months of the study is considerered as a follow-up to evaluate the primary and secondary end points foreseen in the protocol.

I pazienti saranno valutati per un periodo di 24 mesi dopo l'unica somministrazione intravescicale di trattamento attivo che è costituito da mitomicina C a cui viene aggiunto Ialuril Prefill oppure da mitomicina Cin monoterapia, a seconda dei 2 gruppi di trattamento A o B a cui vengono assegnati. Pertanto il periodo di 24 mesi di studio è considerato di follow up per valutare gli end point primari e secondari previsti nel protocollo.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-01-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-15

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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