Clinical Trials Register

Summary
EudraCT Number:	2009-012595-27
Sponsor's Protocol Code Number:	A8081007
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:	2009-11-17
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

2009-012595-27

A.3

Full title of the trial

“Estudio en fase 3, aleatorizado y abierto, de la eficacia y seguridad de PF-02341066 frente a quimioterapia estándar (pemetrexed o docetaxel) en pacientes con cáncer de pulmón no microcítico (NSCLC) avanzado que presentan una translocación o inversión en el locus del gen de la quinasa de linfoma anaplásico (ALK)”

PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF PF-02341066 VERSUS STANDARD OF CARE CHEMOTHERAPY (PEMETREXED OR DOCETAXEL) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION EVENT INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS

A.4.1

Sponsor's protocol code number

A8081007

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	Not Applicable
D.3.2	Product code	PF-02341066
D.3.4	Pharmaceutical form	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.3.9.3	Other descriptive name	IUPAC: (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-
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	50
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	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	Not Applicable
D.3.2	Product code	PF-02341066
D.3.4	Pharmaceutical form	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.3.9.3	Other descriptive name	IUPAC: (R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-
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: 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	ALIMTA 500 mg polvo para concentrado para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	ELI LILLY NETHERLAND BV
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.3.4	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.3.8	INN - Proposed INN	PEMETREXED
D.3.9.3	Other descriptive name	PEMETREXED
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	500
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	TAXOTERE 80 mg concentrado y disolvente para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	AVENTIS PHARMA, S.A.
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.3.4	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.3.8	INN - Proposed INN	DOCETAXEL
D.3.9.1	CAS number	114977-28-5
D.3.9.3	Other descriptive name	DOCETAXEL
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	80
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: 5
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	TAXOTERE 20 mg concentrado y disolvente para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	AVENTIS PHARMA, S.A.
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.3.4	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.3.8	INN - Proposed INN	DOCETAXEL
D.3.9.1	CAS number	114977-28-5
D.3.9.3	Other descriptive name	DOCETAXEL
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	20
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: 6
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	ALIMTA 100 mg polvo para concentrado para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	ELI LILLY NETHERLAND BV
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.3.4	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.3.8	INN - Proposed INN	PEMETREXED
D.3.9.3	Other descriptive name	PEMETREXED
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.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

"CANCER DE PULMON NO MICROCÍTICO (NSCLC) AVANZADO QUE PRESENTA UNA TRANSLOCACIÓN O INVERSIÓN EN EL LOCUS DEL GEN DE LA QUINASA DE LINFOMA ANAPLÁSICO (ALK)"

ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.0
E.1.2	Level	LLT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Objetivo primario:
• Demostrar que PF-02341066 (Grupo A) es superior a la quimioterapia estándar, pemetrexed o docetaxel (Grupo B), en cuanto a la prolongación de la SLP en los pacientes con NSCLC avanzado cuyos tumores presentan una translocación o inversión en el locus del gen ALK y que han recibido sólo un régimen de quimioterapia previo para el NSCLC avanzado y dicho régimen estaba basado en platino.

E.2.2

Secondary objectives of the trial

Objetivos secundarios:
# Evaluar medidas secundarias de eficacia clínica, como tasa de respuesta objetiva (TRO), duración de la respuesta (DR), tasa de control de la enfermedad (TCE) a las 6 y 12 semanas, y supervivencia global (SG) en ambos grupos de trat.# Evaluar seguridad y tolerabilidad de PF-02341066 vs pemetrexed o docetaxel # Comparar los resultados reportados por paciente (RRP) en cuanto a calidad de vida relacionada con salud (HRQoL), síntomas relacionados con enfermedad/trat. del cáncer de pulmón y estado general de salud en ambos grupos de trat. # Caracterizar los efectos de PF-02341066 a dosis terapéuticas sobre QTc en esta población # Determinar PK en esta población por métodos de PK poblacional y explorar correlaciones entre PK, respuesta y/o hallazgos de seguridad. # Explorar la relación entre fusión del gen ALK, proteína ALK y transcripción de la fusión # Correlacionar modulación de biomarcadores solubles con PK y medidas de los resultados

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Subestudios ECG y MUGA - No hay un titulo, fecha o versión para los sub-estudios. Un subgrupo de pacientes del protocolo participaran en los subestudios. Objetivo ECG: Caracterizar los efectos de PF-02341066 sobre el intervalo QTc. Sólo se realizará en 10 centros del mundo (pendiente confirmar si participara España) Objetivo del subestudio MUGA: Ayudar a evaluar la seguridad de PF-02341066 vs quimioterpia estándar. Es muy probable que sólo participe Estados Unidos.

E.3

Principal inclusion criteria

1. Diagnóstico histológico o citológico de NSCLC localmente avanzado o metastásico # 2.Positivo para translocación o inversión en el locus del gen ALK según la prueba FISH con sondas de separación para ALK y definido como aumento en la distancia entre sondas ALK 5’ y 3’ o pérdida de sonda 5’. # 3. Progresión de la enf. después de 1 solo régimen quimioterapia previo basado en platino (puede incluir terapia de mantenimiento). Los pacientes deben ser candidatos para recibir pemetrexed o docetaxel. Incluye: Pacientes que recibieron un régimen de quimioterapia previo basado en platino para el trat.NSCLC de novo Estadío IIIB/IV / Pacientes que recibieron un régimen de quimioterapia previo basado en platino como trat. adyuvante tras la resección quirúrgica de la enf. temprana y cuya enf. ha reaparecido en los 6 meses tras finalización de quimioterapia previa / Pacientes que recibieron un régimen de quimioterapia previo basado en platino en combinación con radioterapia para enf. locorregional en Estadío III, y cuya enf. ha reaparecido en los 6 meses tras finalización de quimioterapia previa / Pacientes que recibieron 2 regimenes de quimioterapia previos basados en platino, siempre que el 1er régimen fuese trat. adyuvante o en combinación con radioterapia para la enf. localmente avanzada / Pacientes que han recibido trat. previo con un inhibidor de tirosín quinasa del EGFR, como erlotinib o gefitinib, si han recibido un solo régimen de quimioterapia previo basado en platino en uno de los supuestos anteriores # 4. Pacientes con metástasis cerebrales si han sido tratadas y estan estables durante un mínimo de 2 semanas, y no estan recibiendo ninguna medicación contraindicada (Criterios Exclusión 11-12). # 5. Cualquier quimioterapia previa o cirugía mayor debe completarse al menos 4 semanas antes de la medicación del estudio. Las irradiaciones y los procedimientos de cirugía menor previos deben completarse al menos 2 semanas antes de la medicación del estudio. Cualquier toxicidad aguda recuperada a grado menor/igual 1 ( excepto alopecia) # 6. Los tumores deben ser medibles según los criterios RECIST. Según Nota de Archivo del equipo Internacional (fecha: 24.Ago.2009) se utilizarán finalmente los criterios RECIST versión 1.1. en lugar de version 1.0. # 7. Mujeres y hombres, de 18 o más años. # 8. Estado funcional ECOG 0-2. # 9. Función orgánica adecuada: Función hepática: AST) y ALT séricas menor/igual 2,5 x LSN, o AST y ALT menor/igual 5 x LSN si los trastornos de la función hepática se deben a la neoplasia de base; sin embargo, para los pacientes que asignados aleatoriamente al Grupo B deban recibir docetaxel, ALT y/o AST no deben ser mayor 1,5 x LSN con una fosfatasa alcalina mayor 2,5 x LSN. Bilirrubina sérica total menor/igual 1,5 x LSN (excepto con enfermedad de Gilbert; sin embargo, para los pacientes que asignados aleatoriamente al Grupo B, deban recibir docetaxel, la bilirrubina sérica total debe ser menor/igual 1 x LSN. Función de la médula ósea: Recuento absoluto de neutrófilos (RAN) mayor/igual 1500/µL. Plaquetas mayor/igual 100,000/µL. Hemoglobina mayor/igual 9.0 g/dL. Función renal: Aclaramiento de la creatinina (fórmula modificada Cockcroft-Gault) mayor/igual 45 ml/min. # 10. Consentimiento informado, firmado y fechado, que indique que el paciente (o su representante legal) ha sido informado de todos los aspectos del ensayo antes de su inclusión. # 11. Disposición y capacidad para cumplir con las visitas programadas, análisis etc.. y otros procedimientos del estudio, incluida la cumplimentación de las medidas de los RRP

E.4

Principal exclusion criteria

1. Tratamiento actual en otro ensayo clínico. # 2. Terapia previa dirigida contra ALK. # 3. Compresión de la médula espinal, meningitis carcinomatosa o enfermedad leptomeníngea. # 4. Cualquiera de los siguientes trastornos en los 6 meses previos al inicio del tratamiento del estudio: infarto de miocardio, angina grave/inestable, cirugía de bypass de arteria coronaria/periférica, insuficiencia cardiaca congestiva o accidente cerebrovascular incluido el accidente isquémico transitorio. # 5. Disritmias cardíacas activas de grado NCI CTCAE mayor/igual 2, fibrilación auricular de cualquier grado o intervalo QTc mayor 470 mseg. # 6. Tratamiento previo con PF-02341066. # 7. Pacientes que, si aleatorizados al Grupo B, deban recibir pemetrexed y presenten NSCLC que sea carcinoma de células escamosas. # 8. Pacientes que, si aleatorizados al Grupo B, deban recibir docetaxel y presenten neuropatía periférica de Grado mayor 2 (CTCAE versión 3.0). # 9. Pacientes que, si aleatorizados al Grupo B, deban recibir docetaxel y estén tratados con medicaciones conc. con polisorbato 80. # 10. Hipertensión no controlada con medicamentos (mayor 150/100 mmHg). # 11. Embarazo o lactancia. # 12. Uso de fármacos o alimentos que sean inhibidores potentes del CYP3A4 por ej. amprenavir, atazanavir, claritromicina, delavirdina, diltiazem, eritromicina, indinavir, itraconazol, ketoconazol, miconazol, nefazodona, nelfinavir, ritonavir, saquinavir, telitromicina, troleandomicina, verapamil, voriconazol, pomelo o el jugo de pomelo. # 13. Uso de fármacos que sean inductores potentes del CYP3A4 por ej. carbamazepina, fenobarbital, fenitoína, rifabutina, rifampina, rifapentina, tipranavir, ritonavir y la hierba de San Juan. # 14. Uso de fármacos que sean sustratos del CYP3A4 con índice terapéutico estrecho, por ej. aripiprazol, ergotamina, halofantrina, pimozida, triazolam, astemizol, cisaprida y terfenadina. # 15. Neoplasias malignas previas (excepto el NSCLC actual): no serán elegibles si hay evidencias de neoplasia maligna activa (a excepción del cáncer cutáneo no-melanoma o cáncer de cérvix in situ, o cáncer de próstata localizado y curado con PSA < LSN) durante los últimos 5 años. # 16. Otras condiciciones médicas o psiquiátricas graves, agudas o crónicas, o alteraciones analíticas que a juicio del investigador y/o del promotor, fueran un riesgo excesivo para la participación en el estudio o a la administración de los fármacos del mismo y que hagan que el paciente no sea adecuado para este ensayo.

E.5 End points

E.5.1

Primary end point(s)

Criterio de valoración principal:
• SLP basada en los criterios RECIST versión 1.0 * (confirmada por una revisión radiológica independiente)
* Según Nota de Archivo proporcionada por el equipo Internacional (fecha: 24.Ago.2009) se utilizarán finalmente los criterios RECIST versión 1.1. en lugar de version 1.0.

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

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

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

De acuerdo con el apartado 13.1 del protocolo, el fin del estudio se define como la fecha en la que se considera que se han reclutado y han completado el estudio suficientes pacientes

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

150

F.4.2.2

In the whole clinical trial

318

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 en el grupo B (quimioterapia estándar) podrán entrar en el estudio A8081005 para tener acceso al PF-02341066 si cumplen los criterios de inclusión/exclusión para dicho estudio. Para los pacientes del grupo A (PF-02341066) el protocolo no específica ningún cuidado post-tratamiento y el médico que les trate será quien decida su siguiente linea de tratamiento

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

2010-01-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-01-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-01-05

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