Clinical Trials Register

Summary
EudraCT Number:	2005-004124-39
Sponsor's Protocol Code Number:	ML19182
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:	2005-11-22
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

Spain - AEMPS

A.2

EudraCT number

2005-004124-39

A.3

Full title of the trial

Ensayo clínico fase II randomizado de radioterapia torácica 3D frente a la combinación de radioterapia torácica 3D y erlotinib (Tarceva®) en pacientes con carcinoma no microcítico de pulmón localizado irresecable o localmente avanzado no susceptible de quimioterapia

A.4.1

Sponsor's protocol code number

ML19182

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dr. Enrique Martínez López
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Information not present in EudraCT
D.2.1.1.1	Trade name	Tarceva® (150 mg)
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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	Erlotinib clorhidrato
D.3.2	Product code	RO50-8231/OSI-774
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ERLOTINIB CLORHIDRATO
D.3.9.1	CAS number	183319-69-9
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	150
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
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	Information not present in EudraCT
D.IMP: 2
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	Information not present in EudraCT
D.2.1.1.1	Trade name	Tarceva® (100 mg)
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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	Erlotinib clorhidrato
D.3.2	Product code	RO50-8231/OSI-774
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ERLOTINIB CLORHIDRATO
D.3.9.1	CAS number	183319-69-9
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	100
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
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	Information not present in EudraCT
D.IMP: 3
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	Information not present in EudraCT
D.2.1.1.1	Trade name	Tarceva® (25 mg)
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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	Erlotinib clorhidrato
D.3.2	Product code	RO50-8231/OSI-774
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ERLOTINIB CLORHIDRATO
D.3.9.1	CAS number	183319-69-9
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	25
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
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

Carcinoma no microcítico de pulmón localizado irresecable o localmente avanzado, no susceptible de quimioterapia. Tratamiento combinado de radioterápica torácica y erlotinib y terapia de mantenimiento con erlotinib en monoterapia

Localized-unresectable or locally advanced non-small cell lung carcinoma, which is not candidate for chemotherapy treatment. Combined treatment of thoracic radiotherapy and sequential treatment with erlotinib as a single agent

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

Determinar la viabilidad y perfil de toxicidad de la combinación de erlotinib (Tarceva®) y radioterapia torácica (con planificación 3D) en el tratamiento de pacientes con carcinoma no microcítico de pulmón, localizado irresecable o localmente avanzado, y que no es susceptible de tratamiento con quimioterapia.

E.2.2

Secondary objectives of the trial

1.- Estimar la eficacia de la combinación de erlotinib (Tarceva®) y radioterapia torácica (con planificación 3D) frente a la radioterapia torácica (con planificación 3D), en términos de:
• Intervalo libre de progresión.
• Tiempo a fracaso de tratamiento.
• Supervivencia global.
• Tasa de respuestas objetivas, según los criterios RECIST.
2.- Comparar la actividad de ambas alternativas: radioterapia-erlotinib frente a radioterapia.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

1.- Firma del consentimiento informado antes del comienzo de los procedimientos específicos del estudio.
2.- Confirmación histológica o citológica de carcinoma no microcítico de pulmón.
3.- Carcinoma de pulmón en estadio IA – IIIB no resecable.
4.- Pacientes no susceptibles de recibir quimioterapia por cualquier causa.
5.- Enfermedad medible, según los criterios RECIST.
6.- Edad ≥ 18 años.
7.- Estado funcional según la escala ECOG ≤ 2.
8.- Adecuadas funciones hematológica, hepática, renal y respiratoria, definidas por los siguientes valores analíticos:
8.1.- Hematología:
- Neutrófilos ≥ 1,5 x 10(9)/L y leucocitos ≥ 3 x 10(9)/L.
- Hemoglobina ≥10 g/dL. Se permite el empleo de eritropoyetina, pero no la transfusión de hematíes para elevar el valor de la hemoglobina.
- Plaquetas ≥100 x 10(9)/L.
8.2.- Función hepática:
- Bilirrubina total ≤ 2 mg/dL.
- ALT (SGPT) y AST (SGOT) ≤ 1,5 veces el límite superior de la normalidad en el Centro.
- Fosfatasa alcalina ≤3 veces el límite superior de la normalidad en el Centro.
8.3.- Función renal:
- Creatinina ≤ 1,5 mg/dL.
8.4.- Función respiratoria:
- VEMS (FEV1) ≥ 1.000 mL
9.- Condiciones físicas, psíquicas o geográficas adecuadas que permitan la administración y el cumplimiento del tratamiento (radioterapia, según recomendaciones del Grupo de Radioterapia de la EORTC, y erlotinib) y su correcto seguimiento.
10.- Las mujeres en edad fértil deben tener un test de embarazo negativo (en suero u orina) dentro de las 7 días previos al inicio del tratamiento.
11.- Los pacientes de ambos sexos en edad fértil (incluyendo las mujeres que hayan tenido la última menstruación hace menos de 2 años) deben seguir un método anticonceptivo adecuado (anticonceptivos orales, dispositivo intrauterino, métodos anticonceptivos de barrera, conjuntamente con gel espermicida, o esterilización quirúrgica).

E.4

Principal exclusion criteria

1.- Quimioterapia o radioterapia previa.
2.- Cualquier proceso maligno previo con un intervalo libre de enfermedad < 5 años, con excepción del carcinoma de piel no melanoma o carcinoma de cérvix uterino resecados.
3.- Mujeres embarazadas o en período de lactancia.
4.- Enfermedades graves concomitantes:
4.1.- Historia previa de infarto de miocardio o angina en los 6 meses previos a la entrada en el estudio. Hipertensión o arritmia no controladas. Insuficiencia cardiaca congestiva.
4.2.- Infección activa no controlada.
4.3.- Úlcera péptica, diabetes mellitus inestable o contraindicación para el tratamiento con corticoides.
4.4.- Enfermedades autoinmunes (lupus, esclerodermia, artritis reumatoide).
5.- Tratamiento concomitante con otra terapia antineoplásica.
6.- Tratamiento con un agente farmacológico en investigación durante las 3 semanas previas a la inclusión del paciente en el estudio o participación en otro estudio de investigación.
7.- Tratamiento previo con erlotinib o cualquier inhibidor del receptor del factor de crecimiento epidérmico (anti-EGFR).
8.- Hipersensibilidad conocida a erlotinib o a cualquiera de los excipientes.
9.- Contraindicación para el tratamiento con radioterapia con intención curativa.
10.- Antecedentes o evidencia, en la exploración neurológica, de otras enfermedades del SNC, por ejemplo convulsiones incontroladas (a menos que se hayan tratado adecuadamente con terapia médica estándar).
11.- Cualquier anomalía oftalmológica significativa conocida de la superficie ocular (no se recomienda el uso de lentes de contacto).
12.- Incapacidad para tomar la medicación oral, procedimientos quirúrgicos previos que afecten a la absorción o impliquen la necesidad de alimentación intravenosa o nutrición parenteral con lípidos.
13.- Cualquier otra enfermedad, alteración metabólica, hallazgo de la exploración física o de laboratorio clínico, que proporcione indicios razonables para sospechar una enfermedad o afección para la que está contraindicado el uso de un fármaco experimental o paciente con riesgo alto de experimentar complicaciones relacionadas con el tratamiento.

E.5 End points

E.5.1

Primary end point(s)

1.- Porcentaje de pacientes que desarrollan toxicidad grado 3-4 durante el tratamiento.
2.- Perfil de toxicidad de los dos esquemas (combinación de erlotinib y radioterapia torácica con planificación 3D frente a la radioterapia torácica con planificación 3D), según la escala NCI-CTCAE v3.0.

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

Information not present in EudraCT

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

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

Radioterapia torácica 3D como tratamiento único

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.8.5

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

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

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

Fallecimiento de todos los pacientes incluidos en el estudio.
Uno de los objetivos secundarios del ensayo es medir la supervivencia global.

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

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.1.3

Elderly (>=65 years)

Yes

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

Information not present in EudraCT

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

No hay previsto ningún tratamiento distinto al habitual para la patología.

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

2006-01-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-12-14

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

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