Clinical Trials Register

Summary
EudraCT Number:	2008-000345-55
Sponsor's Protocol Code Number:	A4021016
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:	2008-04-15
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

2008-000345-55

A.3

Full title of the trial

ESTUDIO DE FASE III, RANDOMIZADO Y ABIERTO DE CP-751.871 EN COMBINACIÓN CON PACLITAXEL Y CARBOPLATINO VERSUS PACLITAXEL Y CARBOPLATINO EN PACIENTES CON CÁNCER DE PULMÓN NO MICROCÍTICO.
RANDOMIZED, OPEN LABEL, PHASE III TRIAL OF CP-751,871 IN
COMBINATION WITH PACLITAXEL AND CARBOPLATIN VERSUS
PACLITAXEL AND CARBOPLATIN IN PATIENTS WITH NON-SMALL CELL
LUNG CANCER

A.3.2

Name or abbreviated title of the trial where available

CP In Combo

A.4.1

Sponsor's protocol code number

A4021016

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 España
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 mg/kg
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	paclitaxel (Taxol®)
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL-MYERS SQUIBB, 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.3.1	Product name	Paclitaxel (Taxol®)
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.3.9.3	Other descriptive name	Paclitaxel (Taxol)
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	10
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	Carboplatin
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	Carboplatin
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.3.9.3	Other descriptive name	Carboplatin
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	6
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

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	10029521
E.1.2	Term	Non-small cell lung cancer stage IIIB

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 principal:
*Determinar si la adición de CP 751.871, un inhibidor IGF 1R, en combinación con paclitaxel más carboplatino prolonga la supervivencia en pacientes con CPNM no adenocarcinomatoso.

E.2.2

Secondary objectives of the trial

Objetivos secundarios:
*Evaluar la supervivencia libre de progresión en cada grupo;
*Evaluar la seguridad y tolerabilidad de CP 751.871 en combinación con paclitaxel y carboplatino;
*Evaluar la tasa de respuesta global en cada grupo;
*Evaluar los resultados de calidad de vida relacionada con la salud (CdVRS) y estado de salud en ambos grupos de tratamiento;
*Recoger datos de la farmacocinética de CP 751.871 para un metaanálisis de farmacocinética de población;
*Controlar la presencia de anticuerpos anti-fármaco en respuesta al tratamiento con CP 751.871;
*Explorar la asociación entre el nivel de IGF-1 pretratamiento y el cambio del IGF-1 con la supervivencia;
*Recogida de muestras de sangre anonimizadas para el perfil molecular.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Diagnóstico de cáncer de pulmón no microcítico cuya histología primaria predominante sea un carcinoma de células escamosas, macrocítico o adenoescamoso, confirmado histológica o citológicamente.
2.CPNM avanzado en estadío IIIB (con derrame pleural), estadío IV o enfermedad recurrente documentado.
3.Sin tratamiento sistémico previo para el CPNM, excepto la quimioterapia adyuvante. La quimioterapia adyuvante deberá haber finalizado ≥12 meses antes de la aleatorización.
4.Se permitirá la cirugía o la radioterapia previas si se han realizado como mínimo 3 semanas antes de la aleatorización y todas las toxicidades se han resuelto a Grado 1 CTC (NCI CTCAE v3.0).
5.Edad ≥18 años.
6.Estado funcional ECOG (EF) de 0 o 1
7.Función orgánica adecuada determinada por los siguientes criterios:
a.Recuento absoluto de neutrófilos (RAN) ≥1.5 x 109/L
b.Recuento plaquetar ≥75 x 109/L
c.Hemoglobina ≥8 g/dl
d.Creatinina sérica </=1.5 veces el límite superior de la normalidad (LSN)
e.Aspartato aminotransferasa sérica (AST; glutamato oxalato transferasa sérica [SGOT]) y alanin aminotransferasa sérica(ALT; glutamato piruvato transferasa sérica [SGPT]) ≤5 x LSN, o </=10 x LSN si las alteraciones hepáticas se deben a la neoplasia subyacente
f.Bilirrubina total </=1.25 x LSN
8.Las mujeres no pueden estar embarazadas ni en periodo de lactancia. Las pacientes o sus parejas deberán ser quirúrgicamente estériles o posmenopáusicas, o acordar el uso de un método de contracepción efectivo mientras reciban el tratamiento de estudio y durante un mínimo de 5 meses más. Todas las mujeres potencialmente fértiles deberán presentar una prueba de embarazo negativa (suero u orina) en las 72 horas anteriores al inicio del tratamiento. Los pacientes o sus parejas deberán ser quirúrgicamente estériles o acordar el uso de un método de contracepción efectivo mientras reciban el tratamiento de estudio y durante un mínimo de 5 meses más. La definición de contracepción efectiva se basará en el criterio del investigador principal o la persona designada.
9.El paciente deberá otorgar un documento de consentimiento informado voluntario y por escrito.
10.Sin ninguna patología aguda o crónica, médica o psiquiátrica severa, o anormalidad analítica que pueda incrementar el riesgo asociado a la participación en el estudio o la administración del fármaco de estudio, o pueda interferir con la interpretación de los resultados del estudio y que, a criterio del investigador, haga que la inclusión del paciente en el estudio sea inadecuada. Ello incluye:
a.Necesidad de tratamiento crónico con dosis terapéuticas de corticosteroides sistémicos (≥100 mg diarios de prednisona o >40 mg diarios de dexametasona) en la semana anterior al tratamiento. Se permitirá el tratamiento con esteroides previo o las bajas dosis de esteroides para el control de las náuseas y vómitos. Se permitirá el uso de corticosteroides para la profilaxis o el tratamiento de náuseas y vómitos, o como premedicación de la quimioterapia, a criterio del investigador.
b.Hipertensión incontrolada, diabetes incontrolada (definida por un nivel de Hb A1c >8%), angina inestable, infarto de miocardio o insuficiencia cardiaca congestiva sintomática en los 12 últimos meses o arritmia cardiaca grave incontrolada.
c.Infección bacteriana, fúngica o viral activa, incluida la hepatitis B (HBV), hepatitis C (HBC) y el virus de la inmunodeficiencia humana (VIH). No será necesario que los pacientes que no presenten síntomas sugestivos de infección se sometan a las pruebas serológicas basales.
d.Neuropatía periférica preexistente > grado 2 CTC
e.Demencia o estado mental significativamente alterado que impediría comprender u otorgar el consentimiento informado, o el cumplimiento de los requisitos del protocolo.
11.Ninguna otra neoplasia activa (aparte del CPNM no adenocarcinomatoso)
12.Paciente sin hipersensibilidad conocida o sospechada a ninguno de los fármacos de estudio (paclitaxel, carboplatino o CP 751.871), las clases de los fármacos de estudio (taxano, platino) o los excipientes de la formulación de los fármacos de estudio (incluido el aceite de ricino y sus derivados, como Cremophor®)
13.Deseo y capacidad para cumplir el programa de visitas, los planes de tratamiento, analíticas u otros procedimientos del estudio, incluidas las medidas de resultados notificados por el paciente (PRO).

E.4

Principal exclusion criteria

1-No se permitirá la evidencia histológica o citológica de cáncer de pulmón microcítico o carcinoide. Se excluirá a los pacientes con CPNM cuya histología primaria sea un adenocarcinoma o sea desconocida o inespecífica (no especificada).
2-Se excluye a los pacientes con metástasis sintomáticas en el sistema nervioso central (SNC).
a.Los pacientes con síntomas sugestivos de metástasis en el SNC se someterán a una evaluación radiológica para descartar posibles metástasis.
b.Se permite incluir a los pacientes con lesiones asintomáticas conocidas en el SNC.
3-No se permite la inclusión en otro ensayo clínico terapéutico.
4-No se permite el tratamiento previo o concurrente con inhibidores del IGF1R ni agonista o antagonista de la hormona de crecimiento

E.5 End points

E.5.1

Primary end point(s)

*Supervivencia global, definida como el tiempo transcurrido desde la aleatorización hasta la fecha de la muerte por cualquier causa.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Information not present in EudraCT

E.6.2

Prophylaxis

Information not present in EudraCT

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Information not present in EudraCT

E.6.8

Bioequivalence

Information not present in EudraCT

E.6.9

Dose response

Information not present in EudraCT

E.6.10

Pharmacogenetic

Information not present in EudraCT

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Information not present in EudraCT

E.6.13

Others

Information not present in EudraCT

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

Information not present in EudraCT

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

Information not present in EudraCT

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

600

F.4.2.2

In the whole clinical trial

820

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)

After the subject ends participation,the patient will undergo care as directed by His/Her Physician.

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

2008-05-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-09-25

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