Clinical Trials Register

Summary
EudraCT Number:	2006-001845-33
Sponsor's Protocol Code Number:	ML20294
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-03-11
Trial results	View 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

2006-001845-33

A.3

Full title of the trial

Estudio fase III randomizado, controlado de erlotinib (Tarceva®) como tratamiento de mantenimiento en pacientes con carcinoma epidermoide de cabeza y cuello resecado y tratado con radioterapia con o sin quimioterapia concomitante con fines curativos

A.4.1

Sponsor's protocol code number

ML20294

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	Roche Farma, S.A.
B.1.3.4	Country	Spain
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
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	Yes
D.2.1.1.1	Trade name	Tarceva
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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
D.3.9.1	CAS number	183319-69-9
D.3.9.2	Current sponsor code	Ro50-8231/OSI-774
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	No
D.3.11.8	Extractive medicinal product	No
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.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	Yes
D.2.1.1.1	Trade name	Tarceva
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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
D.3.9.1	CAS number	183319-69-9
D.3.9.2	Current sponsor code	Ro50-8231/OSI-774
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	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	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	Information not present in EudraCT
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.11	Herbal medicinal product	Information not present in EudraCT
D.3.11.12	Homeopathic medicinal product	Information not present in EudraCT
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	Yes
D.2.1.1.1	Trade name	Tarceva
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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
D.3.9.1	CAS number	183319-69-9
D.3.9.2	Current sponsor code	Ro50-8231/OSI-774
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	No
D.3.11.8	Extractive medicinal product	No
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 epidermoide de cabeza y cuello.

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

Evaluar la eficacia de erlotinib a través del tiempo libre de progresión, tras un seguimiento de 2 años.

E.2.2

Secondary objectives of the trial

Comparar el porcentaje de pacientes libres de progresión a los 2 años.
Calcular la supervivencia global en ambos grupos.
Evaluar el perfil de seguridad de ambos grupos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Antes del comienzo de los procedimientos específicos del protocolo, deberá obtenerse y documentarse el consentimiento informado por escrito.

2. Pacientes con diagnóstico histológico documentado de carcinoma epidermoide de cavidad oral, orofaringe, laringe o hipofaringe, tratados con cirugía y posterior quimiorradioterapia o radioterapia sola con fines curativos. El intervalo entre la cirugía y la quimiorradioterapia o la radioterapia no ha tenido que exceder las 9 semanas. La quimioterapia debe haber incluido cisplatino o derivados del platino.

3. Los pacientes deben haber finalizado la quimiorradioterapia o la radioterapia al menos hace 4 semanas pero no más de 6 semanas.

4. Los pacientes deben cumplir al menos uno de los siguientes criterios:
• T3-T4 patológico, excepto T3N0 de laringe con márgenes negativos;
• N2-3 patológico;
• Hallazgos de mal pronóstico como extensión extranodal, márgenes de resección positivos, afectación perineural y/o vascular

5. Edad > 18 años.

6. ECOG ≤ 2.

7. Esperanza de vida >12 semanas.

8. Ausencia de enfermedad a distancia.

9. Función orgánica adecuada según los siguiente criterios:
a. Reserva medular: recuento absoluto de neutrófilos (ANC) > 1,5 x 109/L, plaquetas > 100 x 109/L y hemoglobina > 9 g/dL.
b. Función hepática: bilirrubina < 1,5 veces el límite superior del rango de normalidad (LSN), fosfatasa alcalina (AP), aspartato transaminasa (AST/GOT) y alanino transaminasa (ALT/GPT) < 3,0 x LSN.
c. Función renal: aclaramiento calculado de creatinina (CrCl) > 60 ml/min o Cr < 1,5 x LSN.
d. Los niveles de calcio sérico deben ser normales.
e. Estudio de coagulación: INR ≤ 1,5 y APPT < 1,5 x UNRL

10. Las mujeres en edad fértil deben tener un test de embarazo negativo dentro de las 48 horas previas al inicio del tratamiento.

11. Los pacientes (de ambos sexos) en edad fértil deben seguir un método anticonceptivo adecuado.

12. Posibilidad de deglución oral o por gastrostomía, o sonda nasogástrica.

13. Los pacientes deben estar accesibles para el tratamiento y el seguimiento.

E.4

Principal exclusion criteria

1. Mujeres embarazadas o en periodo de lactancia.

2. Resección incompleta con enfermedad residual macroscópica tras la cirugía o vaciamiento ganglionar incompleto.

3. Tratamiento previo con agentes dirigidos contra el EGFR.

4. Paciente con diagnóstico de otras enfermedades malignas desde hace cinco años, excepto carcinoma de piel no-melanoma o carcinoma de cérvix uterino resecados.

5. Enfermedades concomitantes graves (a criterio del investigador) o cuya supervivencia estimada sea menor a la de su enfermedad neoplásica.

6. Infección activa.

7. Enfermedad coronaria sintomática o infarto agudo de miocardio en los 6 meses previos al estudio.

8. Enfermedad psiquiátrica grave no controlada.

9. Problemas de tránsito intestinal como síndrome de malabsorción, enfermedad inflamatoria crónica intestinal u otras patologías que puedan alterar la absorción del medicamento.

10. Pacientes que requieran alimentación intravenosa, o que hayan sufrido intervenciones que afecten la absorción, o que tengan úlcera péptica activa.

11. Vómitos frecuentes o trastorno médico que interfiera en la ingestión oral de medicamentos.

12. Anomalías oftalmológicas significativas, incluyendo síndrome de xeroftalmia severa, queratoconjuntivitis seca, síndrome de Sjögren, queratopatía de exposición severa u otros trastornos que puedan aumentar el riesgo de lesiones epiteliales en la córnea (el uso de lentes de contacto durante el estudio puede aumentar el riesgo de lesiones corneales y está claramente desaconsejado: los pacientes que continúen utilizando lentes de contacto necesitarán seguimiento oftalmológico más frecuente).

E.5 End points

E.5.1

Primary end point(s)

Evaluar la eficacia de erlotinib a través del tiempo libre de progresión, tras un seguimiento de 2 años.

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)

Yes

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

Yes

E.8.1.7.1

Other trial design description

Brazo de pacientes en observación.

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

Brazo de pacientes en observación.

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.8.6 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

Yes

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

La terminación del ensayo clínico tendrá lugar en la fecha de la última visita realizada por el último paciente participante en el estudio.

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
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	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	300
F.4.2	For a multinational trial
F.4.2.1	In the EEA	300
F.4.2.2	In the whole clinical trial	300

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

2006-10-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-10-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-12-18

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