Clinical Trials Register

Summary
EudraCT Number:	2016-001186-85
Sponsor's Protocol Code Number:	HIVEC-HR
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:	2016-06-01
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

2016-001186-85

A.3

Full title of the trial

HIVEC HR: USE OF CHEMOHYPERTHERMIA WITH INTRAVESICAL MITOMYCIN (HIVEC) FOR THE TREATMENT OF PATIENTS WITH NMIBC AND HIGH RISK (HR)

HIVEC HR: USO DE LA QUIMIOHIPERTERMIA CON MITOMICINA INTRAVESICAL HIVEC) COMO TRATAMIENTO DEL PACIENTE CON TUMOR VESICULA NO MÚSCULO INFILTRANTE DE RIESGO ALTO (HR)

A.3.1

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

HIVEC HR: USE OF CHEMOHYPERTHERMIA WITH INTRAVESICAL MITOMYCIN (HIVEC) FOR THE TREATMENT OF PATIENTS WITH NMIBC AND HIGH RISK (HR)

HIVEC HR: USO DE LA QUIMIOHIPERTERMIA CON MITOMICINA INTRAVESICAL HIVEC) COMO TRATAMIENTO DEL PACIENTE CON TUMOR VESICULA NO MÚSCULO INFILTRANTE DE RIESGO ALTO (HR)

A.3.2

Name or abbreviated title of the trial where available

HIVEC HR

A.4.1

Sponsor's protocol code number

HIVEC-HR

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	Dr. Felipe Villacampa
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	Laboratorios Inibsa
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	Dr. Felipe Villacampa
B.5.2	Functional name of contact point	Hospital Universitario 12 Octubre
B.5.3	Address:
B.5.3.1	Street Address	Avda. Córdoba s/n
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28041
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34637569593
B.5.6	E-mail	fvillacampa@yahoo.es

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	Laboratorios Inibsa
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.3.1	Product name	Mitomycin-C
D.3.4	Pharmaceutical form	Intravesical solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MITOMYCIN
D.3.9.1	CAS number	50-07-7
D.3.9.4	EV Substance Code	SUB09006MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	Yes
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

Non Muscle Invasive Bladder Cancer

Tumor Vesical No Músculo Infiltrante

E.1.1.1

Medical condition in easily understood language

Superficial Bladder Cancer

Cáncer Vesical Superficial

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate disease free survival time after 24 months follow up of TURBT followed by HIVEC compared with TURBT followed by standard BCG therapy

Evaluar el tiempo libre de enfermedad tras 24 meses de seguimiento de la RTU vesical seguido de tratamiento con HIVEC comparado con RTU vesical seguida de tratamiento estándar con BCG

E.2.2

Secondary objectives of the trial

1. Time to progression of HIVEC vs. BCG
2. Cancer specific survival of HIVEC vs BCG
3. Adverse Events of HIVEC vs BCG
4. QoL of HIVEC vs. BCG

1. Tiempo hasta progresión de HIVEC vs. BCG
2. Supervivencia cáncer específica
3. Efectos secundarios HIVEC vs. BCG
4. Calidad de Vida HIVEC vs. BCG

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. All patients operated of non invasive bladder tumour that meet high
risk criteria as per EORTC risk categories
2. Above 18 years old
3. Accept to participate in the trial and sign the consent form

1. Todos los pacientes operados de tumor no infiltrante de vejiga que
cumplan criterios de riesgo elevado según EORTC
2. Mayores de edad
3. Acepten ser incluidos en el estudio y firmen el consentimiento
informado

E.4

Principal exclusion criteria

1. Patients with invasive lesions or CIS
2. Hypersensitivity or allergy to MMC
3. History of severe adverse reaction to BCG
4. Epithelial cells carcinoma involving prostatic urethra or upper urinary
tract
5. Patients with tumors histologically different than transitional cell
carcinoma
6. Patients that for any reason should receive simultaneous
chemotherapy
7. Withdrawal of CI
8. Pregnant or lactating or women of childbearing age
who do not want or can not use non-hormonal contraceptives
9. Urethral stenosis that contraindicates catheterization for the
instillation
10. Treatment with immunosuppressants that contraindicates BCG
therapy

1. Pacientes con tumor músculo infiltrante, o con Carcinoma In Situ.
2. Hipersensibilidad o alergia a la mitomicina.
3. Antecedentes de reaccion adversa severa a BCG.
4. Carcinoma de células uroteliales comprometiendo uretra prostática o
tracto urinario superior
5. Pacientes con tumores histológicamente diferentes al carcinoma
transicional de vejiga
6. Pacientes que por cualquier motivo deban recibir quimioterapia de
forma simultánea
7. Rechazo o retirada del consentimiento
8. Mujeres embarazadas o en período de lactancia o mujeres en edad
fértil que no deseen o no puedan usar anticonceptivos no hormonales
9. Estenosis de uretra que contraindique el sondaje para la instilación.
10. Tratamiento con inmunosupresores que contraindique la instilación
con BCG.

E.5 End points

E.5.1

Primary end point(s)

Disease Free survival after 24 months follow up

Tiempo libre de enfermedad tras 24 meses de seguimiento

E.5.1.1

Timepoint(s) of evaluation of this end point

24 months after last instillation

24 meses tras la última instilación

E.5.2

Secondary end point(s)

1. Time to progression
2. Cancer specific survival
3. Adverse Events of HIVEC compared with BCG
4. Quality of Life

2. Tiempo libre de progresión
3. Supervivencia cáncer específica.
4. Efectos secundarios en la aplicación de la QHT comparado con
efectos secundarios en la aplicación de la BCG.
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5. Medición de calidad de vida

E.5.2.1

Timepoint(s) of evaluation of this end point

24 months after the last instillation

24 meses tras la última instilación

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

E.6.13.1

Other scope of the trial description

Quality of Life

Calidad de Vida

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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 Last Subject

Ultima Visita Último Paciente

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:

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

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)

Normal treatment of that condition

Tratamiento habitual para su enfermedad

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

2016-06-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-29

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

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