Clinical Trials Register

Summary
EudraCT Number:	2013-002647-29
Sponsor's Protocol Code Number:	ELECTROCHEMO-1
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:	2013-12-27
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

2013-002647-29

A.3

Full title of the trial

Clinical trial to evaluate the efficacy and tolerability of electrochemotherapy for palliative treatment in patients with head and neck squamous cell carcinoma

Ensayo clínico para evaluar la eficacia y tolerabilidad de la Electroquimioterapia como tratamiento paliativo en pacientes con carcinoma escamoso de cabeza y cuello

A.3.1

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

Study to evaluate electrochemotherapy for palliative treatment in patients with head and neck cancer

Estudio para evaluar la electroquimioterapia como tratamiento paliativo en pacientes con cancer de cabeza y cuello

A.4.1

Sponsor's protocol code number

ELECTROCHEMO-1

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	Fundació Clínic per a la Recerca Biomèdica
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	NA
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	Clinical Trials Unit (CTU)
B.5.2	Functional name of contact point	Judit Pich
B.5.3	Address:
B.5.3.1	Street Address	Villarroel, 170
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	349322754002815
B.5.5	Fax number	34932279877
B.5.6	E-mail	jpich@clinic.ub.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	Bleomicina Mylan
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan Pharmaceuticals, S.L.
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	bleomycin
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BLEOMYCIN
D.3.9.1	CAS number	11056-06-7
D.3.9.4	EV Substance Code	SUB00842MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
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

head and neck squamous cell carcinoma

carcinoma escamoso de cabeza y cuello

E.1.1.1

Medical condition in easily understood language

head and neck cancer

cancer de cabeza y cuello

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	16.1
E.1.2	Level	PT
E.1.2	Classification code	10060121
E.1.2	Term	Squamous cell carcinoma of head and neck
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	HLGT
E.1.2	Classification code	10019190
E.1.2	Term	Head and neck therapeutic procedures
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10067821
E.1.2	Term	Head and neck cancer
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

Palliation of symptoms in patients who have one or more tumors cutaneous or subcutaneous as relapse or progression of carcinoma of head and neck palliative chemotherapy-resistant and those no other effective local treatments can be offered.

Paliación de síntomas en pacientes que presenten uno o más tumores cutáneos o subcutáneos como recidiva o progresión de carcinoma de cabeza y cuello resistentes a quimioterapia paliativa y en los que no se pueda ofrecer otros tratamientos locales eficaces.

E.2.2

Secondary objectives of the trial

1 Evaluation of tumor response
2. Progression-free survival
3. Overall survival
4 Tolerance and toxicity of the procedure
5. Exploratory analysis of possible factors involved in response and clinical progression

1. Valoración de la respuesta tumoral
2. Supervivencia libre de progresión
3. Supervivencia global
4. Tolerancia y toxicidad del procedimiento
5. Análisis exploratorio de posibles factores pronósticos implicados en la respuesta y en la progresión clínica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Patients of both sexes and equal to or more than 18 years old
2) Patients with one or more cutaneous or subcutaneous local or locoregional tumors as relapse or progression of squamous cell carcinoma of head and neck
3) Patients with a tumor that does not invade the wall of the artery carotid with risk of rupture
4) Patients whose target lesion is resistant to palliative chemotherapy and which cannot be applied palliative local treatments such as radiotherapy, surgery of scarce mutilation or first-line systemic chemotherapy
5) Patients with a expectation of life of 2-3 months
6) Patients with a degree of activity of the ECOG scale of 2 or less
7) Patients who, properly informed, consent in writing to participate in the study and submit to the tests and procedures required by the study

1) Pacientes de ambos sexos y de edad igual o superior a 18 años
2) Pacientes que presenten uno o más tumores cutáneos o subcutáneos locales o locorregionales como recidiva o progresión de carcinoma escamoso de cabeza y cuello
3) Pacientes con un tumor que no invada la pared de la arteria carótida con riesgo de ruptura
4) Pacientes cuya lesión diana sea resistente a quimioterapia paliativa y a los que no se puedan aplicar tratamientos paliativos locales como radioterapia, cirugía de escasa mutilación o quimioterapia sistémica de primera línea
5) Pacientes con una expectativa de vida de entre 2 y 3 meses
6) Pacientes con un grado de actividad de la escala ECOG de 2 o menor
7) Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta

E.4

Principal exclusion criteria

1) Pregnancy or lactation during the study period
2) Patients with allergy to Bleomycin
3) Patients who have received the maximum dose of Bleomycin (400 mgm2)
4) Patients with previous pulmonary fibrosis or hemolytic uremic syndrome
5) Use of drugs contraindicated in the study procedure
6) Contraindication for the use of any of the drugs /products of the study
7) Hypersensitivity to any components of the anesthesia used during the procedure
8) Patients with creatinine> 1.5 values mgdL
9) Patients with severe coagulopathy prior at the entry of the study
10) Patients enrolled in other clinical trials at the same time

1) Embarazo o lactancia durante el periodo del estudio
2) Pacientes con alergia previa a Bleomicina
3) Pacientes que hayan recibido la dosis máxima de Bleomicina (400 mg/m2)
4) Pacientes con fibrosis pulmonar previa o síndrome hemolítico urémico
5) Utilización de fármacos contraindicados en el procedimiento en estudio
6) Contraindicación para el uso de alguno de los fármacos/productos del estudio
7) Hipersensibilidad conocida a cualquiera de los componentes de la anestesia a utilizar durante el procedimiento
8) Pacientes con valores de creatinina > 1.5 mg/dL
9) Pacientes con coagulopatías graves previas
10) Pacientes incluidos en otros ensayos clínicos al mismo tiempo

E.5 End points

E.5.1

Primary end point(s)

Assessment of changes in symptoms using the test of quality of life of Edmonton at 6 weeks after the procedure with respect to the baseline.

Evaluación de los cambios en los síntomas mediante el test de calidad de vida de Edmonton a las 6 semanas del procedimiento respecto al basal.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 weeks

6 semanas

E.5.2

Secondary end point(s)

1. Response rate objective: incidence of complete response or partial response or tumor stabilization according to RECIST 1.1 criteria at 6 and 12 weeks of treatment.
2. Time elapsed since the date of the inclusion until progression of disease according to RECIST 1.1 criteria
3. Time elapsed since the date of the inclusion until the date of death.
4 Incidence of systemic and local events related to the study procedure
5 Incidence of events adverse serious procedure in study-related
6. Exploratory analysis of possible factors involved in response and clinical progression

1. Tasa de respuesta objetiva: incidencia de Respuesta Completa (RC) o Respuesta Parcial (RP) o Estabilización Tumoral (ET) según los criterios RECIST 1.1 a las 6 y 12 semanas de tratamiento.
2. Tiempo transcurrido desde la fecha de la inclusión hasta la fecha de progresión de la enfermedad según los criterios RECIST 1.1
3. Tiempo transcurrido desde la fecha de la inclusión hasta la fecha de la muerte.
4. Incidencia de acontecimientos locales y sistémicos relacionados con el procedimiento en estudio
5. Incidencia de Acontecimientos Adversos Graves relacionados con el procedimiento en estudio
6. Análisis exploratorio de posibles factores pronósticos implicados en la respuesta y en la progresión clínica

E.5.2.1

Timepoint(s) of evaluation of this end point

6 weeks, 12 weeks, at the end of study

6 semanas, 12 semanas, al finalizar el estudio

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

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)

E.8.2.2

Placebo

E.8.2.3

Other

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 patient

última vista del 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 for that condition

tratamiento estandar para la condición en estudio

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

2014-02-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-31

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

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