Clinical Trials Register

Summary
EudraCT Number:	2008-001168-35
Sponsor's Protocol Code Number:	A4021018
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:	2008-05-06
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

2008-001168-35

A.3

Full title of the trial

ENSAYO ALEATORIZADO, ABIERTO, EN FASE 3 DE ERLOTINIB SOLO O EN COMBINACION CON CP-751,871 EN PACIENTES CON CANCER DE PULMON NO MICROCITICO AVANZADO DE HISTOLOGIA NO ADENOCARCINOMATOSA.

A.4.1

Sponsor's protocol code number

A4021018

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	PFIZER, 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	No
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	CP-751,871
D.3.4	Pharmaceutical form	Intravenous infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	CP-751,871
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	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	Tarceva
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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.3.1	Product name	Erlotinib hydrochloride
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.3.9.1	CAS number	183321-74-6
D.3.9.3	Other descriptive name	Erlotinib
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: 3
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	Tarceva
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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.3.1	Product name	Erlotinib hydrochloride
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.3.9.1	CAS number	183321-74-6
D.3.9.3	Other descriptive name	Erlotinib
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	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: 4
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	Tarceva
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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.3.1	Product name	Erlotinib hydrochloride
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.3.9.1	CAS number	183321-74-6
D.3.9.3	Other descriptive name	Erlotinib
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

CPNM avanzado de histología no adenocarcinomatosa.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10025055
E.1.2	Term	Lung cancer non-small cell stage IV

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Comparar la supervivencia global (SG) en pacientes con CPNM avanzado con histología no adenocarcinomatosa tratados con erlotinib solo (grupo B) o con CP 751,871 más erlotinib (grupo A). Los pacientes del grupo B podrán haber recibido monoterapia con CP 751,871 tras haber presentado progresión con erlotinib solo.

E.2.2

Secondary objectives of the trial

•Comparar la supervivencia sin progresión (SSP) en pacientes con CPNM avanzado con histología no adenocarcinomatosa tratados con erlotinib solo (grupo B) o con CP 751,871 más erlotinib (grupo A).
•Evaluar la seguridad y la tolerabilidad de múltiples dosis de CP 751,871;
•Evaluar la eficacia de CP 751,871 mediante la TRO;
•Obtener datos FC de CP 751,871 para futuros metaanálisis de FC poblacional;
•Controlar la aparición de anticuerpos contra el fármaco en respuesta a CP 751,871;
•Evaluar la presencia de células tumorales circulantes (CTCs) que expresen el IGF IR;
•Evaluar las diferencias en las utilidades del estado de salud, mediante el cuestionario EQ 5D.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Varones o mujeres de edad > 18 años
2. Carcinoma pulmonar no microcítico demostrado por histología o citología, con una histología primaria de carcinoma de células escamosas, macrocítico o adenoescamoso y sus variantes (Apéndice 11), con metástasis (estadio IV o enfermedad recurrente) o localmente avanzado (estadio IIIB) con derrame pleural maligno.
3. Pacientes en quienes erlotinib sea una opción de tratamiento razonable. El paciente deberá haber recibido tratamiento previo para la enfermedad avanzada, consistente al menos en una pauta de combinación basada en platino. No obstante, los pacientes de edad igual o superior a 70 años podrán haber recibido monoterapia en al menos una ocasión. En los países en que el uso y disponibilidad de docetaxel o pemetrexed sean el estándar asistencial, los pacientes también deberán haber recibido tratamiento previo con uno o ambos, o presentar una contraindicación significativa a uno o a ambos.
4. Al menos 1 lesión mensurable, según los RECIST. Todas las lesiones diana deberán tener un diámetro unidimensional de 2 cm como mínimo (se acepta que mida 1 cm en las TC helicoidales, si el algoritmo de reconstrucción es de 0,5 cm). Las mediciones/evaluaciones basales deberán estar realizadas en las 4 semanas previas a la aleatorización y se harán en el centro de investigación participante.
5. Estado funcional (ECOG) de 0-2.
6. Deberán haber transcurrido 2 semanas como mínimo desde el último ciclo de tratamiento sistémico hasta la inclusión. Los pacientes deberán haber alcanzado el grado < 1 de los CTCAE del NCI v 3.0 en todos los efectos tóxicos agudos (excepto aquellos de grado 1 que el promotor y el investigador no consideren riesgos para la seguridad), o el investigador deberá considerar que se trata de toxicidad irreversible.
7. Deberá haber transcurrido una semana como mínimo desde la última sesión de radioterapia. Los pacientes se habrán recuperado de todos los efectos secundarios agudos de la radioterapia.
8. El paciente deberá presentar las funciones hematológica, renal y hepática adecuadas, definidas por: hemoglobina > 9 g/dl, neutrófilos > 1.000/mm3, plaquetas > 50.000/mm3, creatinina < 2 mg/ml y AST (SGOT) y/o ALT (SGPT) < 5 x LSN (límite superior normal).
9. Disposición y capacidad de cumplir las visitas programadas, los planes de tratamiento, las pruebas analíticas y otros procedimientos del estudio, entre ellos, la aportación de extensiones o cortes incluidos en parafina para el diagnóstico y la determinación de los resultados comunicados por los pacientes.
10. Prueba de embarazo negativa dentro de la semana anterior a la dosis inicial de CP-751,871 en las mujeres con potencial fértil. Las mujeres deben estar esterilizadas quirúrgicamente o ser posmenopáusicas, o deben acceder a emplear un método anticonceptivo de doble barrera durante el periodo de tratamiento y hasta 5 meses después de la última dosis de medicación del estudio. Se consideran anticonceptivos de doble barrera el preservativo más espermicida en combinación con un preservativo femenino, diafragma o tapón cervical, o el preservativo más espermicida en combinación con un dispositivo intrauterino. Dentro de estos límites, la elección del método anticonceptivo específico se deja a la discreción del sujeto o del investigador principal.
11. Comprensión del consentimiento informado por escrito, voluntario, firmado y fechado.

E.4

Principal exclusion criteria

1. 1. Histología del CPNM primario no incluida en el criterio de inclusión nº 1. CPNM primario de tipo adenocarcinoma y sus subtipos: acinar, papilar, bronquioalveolar, sólido, fetal, mucinoso, en anillo de sello y de células claras, o con histología mixta de todos estos tipos. Histología del CPNM desconocida o no especificada (sin más detalles).
2. Tratamiento previo con erlotinib.
3. Tratamiento experimental previo basado en anti IGF IR. Otros tratamientos experimentales (dirigidos o vacunas), a menos que el investigador y el promotor acuerden otra cosa, necesitarán un período de lavado de 2 semanas antes de la inclusión.
4. Metástasis cerebrales sintomáticas. Metástasis cerebrales estables durante menos de 2 semanas antes de la administración, o que requieren corticoterapia o con síntomas clínicos. Síntomas clínicos indicativos de metástasis cerebral nueva en las 2 semanas previas a la inclusión, a menos que se descarte la presencia de metástasis cerebrales nuevas por TC o RM.
5. Cirugía mayor en las 3 semanas previas a la inclusión en el estudio o recuperación incompleta de los efectos secundarios de procedimientos anteriores.
6. Neoplasias malignas anteriores (menos de 3 años antes) o actuales y que no sean carcinoma cervical uterino in situ ni carcinoma de células basales o epidermoide de la piel que hayan recibido tratamiento curativo.
7. Diabetes no controlada (definida por una Hb A1c > 8 %).
8. Cardiopatía activa significativa, como: hipertensión no controlada (es decir, presión arterial sistólica > 180 mm Hg, presión arterial diastólica > 95 mm Hg), angina inestable, trombosis venosa profunda, embolia pulmonar, accidente cerebrovascular, valvulopatía, insuficiencia cardíaca congestiva, infarto de miocardio (en los 6 meses previos) o arritmias cardíacas graves.
9. Cualquier otro trastorno médico o infección activa graves no controlados que mermarían la capacidad para recibir el tratamiento del estudio, en opinión del investigador.
10. Pacientes que reciban corticoterapia sistémica inmunosupresora en dosis altas (>100 mg de prednisona al día o > 40 mg de dexametasona al día) en las 2 semanas previas a la inclusión. Se permite el tratamiento previo con esteroides en dosis moderadas a elevadas, pero se suspenderá en el momento de inclusión. Se permite el uso de esteroides tópicos, esteroides inhalados y esteroides en dosis bajas en el momento de la aleatorización (p. ej., cortisona 30 mg/día, prednisona 5 mg/día).
11. Demencia o alteración importante del estado mental que limitaría la comprensión o la concesión del consentimiento informado y el cumplimiento de los requisitos de este protocolo.
12. Embarazo o lactancia.

E.5 End points

E.5.1

Primary end point(s)

Criterio Primario de Valoración: Supervivencia global.

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

Yes

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

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

Study group not treated with test IMP only Erlotinib

E.8.3

The trial involves single site in the Member State concerned

Information not present in EudraCT

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

350

F.4.2.2

In the whole clinical trial

600

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)

Los pacientes podrán recibir tratamiento durante un año como máximo, salvo que presenten toxicidad intolerable. Si se demuestran la seguridad, la tolerabilidad y el beneficio clínico del tratamiento, se podrá seguir administrando más de 1 año, previo acuerdo con el investigador y el promotor. Los pacientes de los 2 grupos podrán recibir el MTS durante el 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

2008-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-06-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-04-26

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