Clinical Trials Register

Summary
EudraCT Number:	2015-005151-27
Sponsor's Protocol Code Number:	PREMITO2015
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-03-18
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

Spain - AEMPS

A.2

EudraCT number

2015-005151-27

A.3

Full title of the trial

Randomized prospective clinical trial to evaluate the rate of early recurrence in bladder cancer in non-muscle invasive between the chemohyperthermia (QH) with mitomycin-C prior to transurethral resection of bladder in ambulatory surgery program and post resection treatment with mitomycin C in normothermia.

Ensayo clínico prospectivo aleatorizado para evaluar la tasa de recurrencia precoz en el Cáncer de vejiga no músculo invasivo entre el uso de quimio-hipertermia (QH) con Mitomicina-C previo a la resección transuretral de vejiga en un programa de Cirugía mayor ambulatoria y el tratamiento con mitomicina C en normotermia post resección.

A.3.1

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

Clinical trial to evaluate recurrence in bladder cancer using two differents strategies of treatment: chemohyperthermia (QH) with mitomycin-C prior to transurethral resection of bladder in ambulatory surgery program or post resection treatment with mitomycin C in normothermia

Ensayo clínico de quimio-hipertermia (QH) con Mitomicina-C previo a la resección transuretral de vejiga frente a Mitomicina post resección en normotermia. Relación con la tasa de recurrencia precoz en el Cáncer de vejiga no músculo invasivo.

A.3.2

Name or abbreviated title of the trial where available

PREMITO

A.4.1

Sponsor's protocol code number

PREMITO2015

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	Hospital Universitario de Canarias
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fundación Canaria de Investigacion Sanitaria
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital Universitario de canarias
B.5.2	Functional name of contact point	UCICEC
B.5.3	Address:
B.5.3.1	Street Address	Planta 1. Edif hospitalización. Ofra s/n. La Cuesta
B.5.3.2	Town/ city	La Laguna
B.5.3.3	Post code	38320
B.5.3.4	Country	Spain
B.5.4	Telephone number	34922678117
B.5.5	Fax number	34922677284
B.5.6	E-mail	aaldperh@gobiernodecanarias.org

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 40 mg Polvo para solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	INIBSA HOSPITAL, S.L.U.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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 40 mg Polvo para solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	INIBSA HOSPITAL, S.L.U.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

pacientes diagnosticados de neoplasia vesical no músculo invasivo (aspecto macroscópico por cistoscopia y ecográfico) candidatos a RTU-vesical en CMA

E.1.1.1

Medical condition in easily understood language

patients with vesical cancer non invasive and selected for resection without hospitalization

pacientes diagnosticados de neoplasia vesical no músculo invasivo candidatos a resección ambulatoria

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	SOC
E.1.2	Classification code	10038359
E.1.2	Term	Renal and urinary disorders
E.1.2	System Organ Class	10038359 - Renal and urinary disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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

to evaluate the recurrence rate of the intravesical cancer non invasive at 12, 18 and 24 months post MMC instillation using hiperthermia pre uretral resection or normothermia post uretral resection

Valorar la tasa de recurrencia precoz a 12, 18 y 24 meses del cáncer de vejiga no músculo invasivo de riesgo bajo e intermedio tras la instilación de MMC empleando sistemas de hipertermia previo a la RTU-Vesical (en comparación con el tratamiento estándar).

E.2.2

Secondary objectives of the trial

To Evaluate tolerance and safety in patients treated with QH MMC instillations of pre-RTU-V patients.
To Evaluate tolerance of early instillation after TUR-V MMC (standard of care)
To Explore possible predictors of response (in terms of recurrence and disease progression) to treatment with MMC QH of previous patients to outpatient RTU-V.
To Analyze the efficiency of treatment with QH and MMC of patients prior to the RTU-V outpatients.
To analyze the degree of satisfaction of patients after completion of the procedure on an outpatient basis.
To Compare the quality of life of patients before and after treatment and its possible impact on sexual life.
To Explore possible predictors of income after QH RTU-bladder prior to outpatients.

Evaluar la tolerancia y seguridad de los pacientes a las instilaciones con QH con MMC de los pacientes previo a la RTU-V.
Evaluar tolerancia de la instilación precoz tras RTU-V con MMC (estándar de tratamiento)
Estudiar posibles factores predictores de respuesta (en términos de recurrencia y progresión de la enfermedad) al tratamiento con QH con MMC de los pacientes previo a la RTU-V ambulatoria.
Analizar la eficiencia del tratamiento con QH y MMC de los pacientes previo a la RTU-V en régimen ambulatorio.
Analizar el grado de satisfacción de los pacientes tras la realización del procedimiento en régimen ambulatorio.
Comparar la calidad de vida de los pacientes pre y post tratamiento y su posible repercusión en la vida sexual.
Estudiar posibles factores predictores de ingreso tras QH previo a RTU-vejiga en régimen ambulatorio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

More than 18 years
vesical tumor <3cm
multiple vesical tumors, in total <8 cm and <3cm each one
ASA less or equal than III
low or intermediate risk

- Edad: Mayores de 18 años
- Neoplasia vesical única < 3cm
- Neoplasia vesical múltiple < 8 en total y < de 3 cm
- ASA menor o igual a III
- Riesgo bajo o Riesgo intermedio:

E.4

Principal exclusion criteria

- Known hipersensibility to MMC or excipients.
- Pregnant or lactancy
- Recent Transuretral resection (<2 years)
- Vesical in situ carcinoma suspected (Cis).
- Vesical tumor > 3 cm
- to have more than 8 tumors
- Severe cardiopathy
- Chronic renal insufficinecy
- Trombocitopenia ( <100.000 platets) ,coagulation disorders and bleeding tendency for other causes.

- Hipersensibilidad conocida a la MMC o al excipiente.
- Embarazadas / Lactancia
- Antecedentes de RTU-V reciente (< 2 años)
- Sospecha de carcinoma vesical in situ (Cis).
- Tumor vesical > 3 cm
- Tener > de 8 tumores
- Cardiopatía severa
Insuficiencia renal crónica
Trombocitopenia ( <100.000 plaquetas) , alteraciones de coagulación y mayor tendencia al sangrado debido a otras causas,

E.5 End points

E.5.1

Primary end point(s)

tumoral recurrence post uretral resection

recurrencia tumoral después de la resección uretral (RTU)

E.5.1.1

Timepoint(s) of evaluation of this end point

at 12, 18 and 24 months.

al año, año y medio y a los dos años.

E.5.2

Secondary end point(s)

adverse events, predictor factors in the treatment response and hospitalization, life quality and sexual health

eventos adversos, factores predictores de ingreso o de respuesta al tratamiento, calidad de vida y salud sexual.

E.5.2.1

Timepoint(s) of evaluation of this end point

at 12, 18 and 24 months

a los 12, 18 y 24 meses

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

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

Yes

E.8.1.7.1

Other trial design description

existe ciego para el evaluador de la recurrencia por pruebas de imagen

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.3.1

Comparator description

mitomicina instalada en normotermia y post resección trans uretral (RTU)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

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

last visit of the last subject undergoing the trial

última visita del último paciente reclutado en el ensayo

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

183

F.4.2

For a multinational trial

F.4.2.1

In the EEA

183

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)

Following clinical practice

Post finalizar el ensayo, se seguirá al paciente según la práctica habitual.

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

2016-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-28

P. End of Trial
P.	End of Trial Status	Ongoing

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