Clinical Trials Register

Summary
EudraCT Number:	2008-001298-13
Sponsor's Protocol Code Number:	A4021008
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:	2008-05-13
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

2008-001298-13

A.3

Full title of the trial

“Estudio en fase 2 aleatorizado y abierto de CP-751,871 en combinación con docetaxel y docetaxel en monoterapia como tratamiento de primera línea de pacientes con cáncer de mama avanzado”

"A RANDOMIZED PHASE 2, OPEN-LABEL STUDY OF CP-751,871 IN COMBINATION WITH DOCETAXEL AND DOCETAXEL ALONE AS A FIRST LINE TREATMENT OF PATIENTS WITH ADVANCED BREAST CANCER"

A.4.1

Sponsor's protocol code number

A4021008

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
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/ml milligram(s)/millilitre
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	TAXOTERE
D.2.1.1.2	Name of the Marketing Authorisation holder	Aventis Pharma Dagenham
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	Concentrate for solution for 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.3.9.1	CAS number	114977-28-5
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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)	Information not present in EudraCT
	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	TAXOTERE
D.2.1.1.2	Name of the Marketing Authorisation holder	Aventis Pharma Dagenham
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	Concentrate for solution for 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.3.9.1	CAS number	114977-28-5
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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)	Information not present in EudraCT
	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 mama avanzado"

"Advanced Breast Cancer"

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	10006187
E.1.2	Term	Breast 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

Evaluar la supervivencia sin progresión (SSP) en pacientes aleatorizadas para recibir CP 751,871 en combinación con docetaxel y la SSP en pacientes aleatorizadas para recibir docetaxel en monoterapia como tratamiento de primera línea del cáncer de mama avanzado.

E.2.2

Secondary objectives of the trial

• Evaluar la respuesta global (RC+RP) en las pacientes aleatorizadas para recibir CP 751,871 en combinación con docetaxel y en las aleatorizadas a monoterapia con docetaxel.
• Obtener información preliminar sobre supervivencia en las pacientes aleatorizadas a CP 751,871 en combinación con docetaxel y en las aleatorizadas a docetaxel en monoterapia.
• Evaluar la seguridad y la tolerabilidad de dosis múltiples de CP 751,871 combinadas con docetaxel y las de docetaxel en monoterapia.
• Evaluar la presencia de células tumorales circulantes (CTCs) que expresen el IGF IR.
• Obtener datos de la FC de CP 751,871 para futuros metanaálisis de FC poblacional.
• Vigilar la aparición de anticuerpos contra el fármaco (ACF) en respuesta a CP 751,871.
• Examinar los resultados comunicados por las pacientes tratadas con CP 751,871 en combinación con docetaxel y con docetaxel solo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Las pacientes deben cumplir todos los criterios de inclusión siguientes para ser candidatas a la inclusión en el estudio, a menos que haya una razón convincente que deben acordar el investigador y el promotor antes de la aleatorización:
1. Mujeres de al menos 18 años.
2. Diagnóstico de cáncer de mama confirmado por histología o citología, con evidencia de enfermedad metastásica (estadio IV) o enfermedad localmente recidivante no susceptible de resección o radioterapia curativas (estadio IIIB).
3. Cáncer de mama negativo para Her-2 (esto es, FISH negativa o IHQ de 0-1+) o estado desconocido de Her-2.
4. Al menos una lesión mensurable, según los RECIST.
5. Se permite la radioterapia previa (más de 1 semana antes de la aleatorización), siempre que no sea a la única localización de la enfermedad mensurable. Las lesiones mensurables que se hayan irradiado sólo se considerarán mensurables cuando aumenten de tamaño. Las pacientes se habrán recuperado de todos los efectos secundarios agudos antes de la aleatorización.
6. Las pacientes que tengan progresión durante el tratamiento hormonal por enfermedad avanzada deberán suspender el tratamiento hormonal al menos 1 semana antes de la aleatorización.
7. Resolución de todos los efectos tóxicos agudos de tratamientos o procedimientos quirúrgicos previos a grado ≤ 1 de los CTC (excepto alopecia u otros AA que no constituyan un riesgo de seguridad).
8. Las pacientes deben ser candidatas al tratamiento con docetaxel según la ficha técnica local.
9. Se permite el tratamiento actual con bisfosfonatos si se ha instaurado al menos dos semanas antes de la aleatorización.
10. Las pacientes deben tener un estado funcional del ECOG de 0-1 (véase el Apéndice 3).
11. Las pacientes deben tener una función hematológica, renal, hepática y cardíaca adecuada, documentada antes de la aleatorización, tal y como se define con los siguientes criterios, a menos el investigador y el promotor acuerden otra cosa:
- RAN ≥1,5 x 109/l;
- Plaquetas ≥ 100 x 109/l;
- Hemoglobina ≥ 8 g/dl;
- Nivel de creatinina sérica ≤1,5 x LSN;
- Bilirrubina sérica ≤ LSN;
- ALT y/o AST <2,5 x LSN; sin embargo, ALT y/o AST ≤1,5 LSN si es simultáneo con una fosfatasa alcalina >2,5 x LSN;
- Fosfatasa alcalina ≤ 5 x LSN;
- Fracción de eyección del ventrículo izquierdo ≥50 % medida mediante ventriculografía isotópica en equilibrio (MUGA) o ecocardiograma (ECHO)
12. Las mujeres (o sus parejas) deberán estar esterilizadas por métodos quirúrgicos o ser posmenopáusicas, o deberán acceder a usar un método anticonceptivo eficaz mientras reciban el tratamiento del estudio y por lo menos 5 meses después. Todas las mujeres en edad fértil deberán dar negativo en una prueba de embarazo (suero/orina) en la semana (preferiblemente las 72 horas) anterior al inicio del tratamiento. La definición de anticoncepción adecuada se incluirá en el consentimiento informado de la paciente, de conformidad con las normas locales. Las mujeres no podrán estar lactando.
13. Consentimiento informado firmado y fechado.
14. Pacientes dispuestas a cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio y capaces de hacerlo.

E.4

Principal exclusion criteria

Las pacientes que presenten cualquiera de las circunstancias siguientes no serán incluidas en el ensayo, a menos que haya una razón convincente acordada por el investigador y el promotor antes de la aleatorización:
1. Quimioterapia previa para la enfermedad avanzada.
2. Exposición previa a taxanos como tratamiento (neo)adyuvante menos de 12 meses antes de la aleatorización.
3. Tratamiento experimental previo basado en anti-IGF-IR.
4. Tratamiento experimental previo dentro de las 4 semanas previas a la aleatorización.
5. 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 cerebrales nuevas en las dos semanas anteriores a la aleatorización. Ante la presencia de tales signos, se descartarán nuevas metástasis cerebrales mediante TC o RM.
6. Neuropatía periférica de grado > 2.
7. Cirugía dentro de las 4 semanas previas a la aleatorización.
8. Radioterapia de más del 25 % de la médula ósea.
9. Antecedentes de reacciones de hipersensibilidad de carácter grave al docetaxel o a otros fármacos formulados con polisorbato 80.
10. Pacientes con hipersensibilidad conocida al tratamiento con anticuerpos.
11. Uso de corticosteroides en dosis elevadas en las 2 semanas previas al reclutamiento (> 100 mg de prednisona al día o > 40 mg de dexametasona al día).
12. Antecedentes de cáncer distinto del cáncer de mama en los 5 años anteriores al comienzo del estudio, a excepción de carcinoma de cuello uterino in situ, carcinoma basocelular o carcinoma epidermoide de la piel debidamente tratados.
13. Un trastorno médico o una infección activa grave no controlada (p. ej., VIH y VHB).
14. Cardiopatía activa significativa, como: hipertensión arterial no controlada (es decir, presión arterial sistólica > 180 mm Hg, presión arterial diastólica > 95 mm Hg a pesar de tratamiento médico óptimo), 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.
15. 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.

E.5 End points

E.5.1

Primary end point(s)

Supervivencia sin progresión (SSP): se define como el tiempo transcurrido entre la aleatorización y la fecha de progresión o de muerte por cualquier causa, lo que suceda antes. La documentación de la progresión debe hacerse por evaluación objetiva de la enfermedad (mediante pruebas con caliper (lesiones de superficie) o pruebas en estudio de imagen) definida por los criterios de evaluación de la respuesta en tumores sólidos (RECIST).

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

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

Information not present in EudraCT

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Information not present in EudraCT

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Information not present in EudraCT

E.7.4

Therapeutic use (Phase IV)

Information not present in EudraCT

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

Information not present in EudraCT

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

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

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

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
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	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
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	Information not present in EudraCT
F.4 Planned number of subjects to be included
F.4.1	In the member state	30
F.4.2	For a multinational trial
F.4.2.1	In the EEA	100
F.4.2.2	In the whole clinical trial	200

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

2008-06-06

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

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