Clinical Trials Register

Summary
EudraCT Number:	2005-002717-21
Sponsor's Protocol Code Number:	A4021011
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:	2007-07-26
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

2005-002717-21

A.3

Full title of the trial

A PHASE 2, RANDOMIZED, NON-COMPARATIVE, TWO-ARM OPEN LABEL, MULTIPLE-CENTER STUDY OF CP-751,871 IN COMBINATION WITH DOCETAXEL/PREDNISONE IN CHEMOTHERAPY- NAÏVE (ARM A) AND DOCETAXEL/PREDNISONE REFRACTORY (ARM B) PATIENTS WITH HORMONE INSENSITIVE PROSTATE CANCER

Estudio en fase 2, aleatorizado, no comparativo, abierto, multicéntrico, con dos grupos, de CP-751,871 en combinación con docetaxel/prednisona en pacientes con cáncer de próstata resistente a hormonas sin quimioterapia previa (Grupo A) o refractarios a docetaxel /prednisona (Grupo B)

A.4.1

Sponsor's protocol code number

A4021011

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.3.2	Product code	CP-751,871
D.3.4	Pharmaceutical form	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.3.9.2	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	5
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	Information not present in EudraCT
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	Information not present in EudraCT
D.3.11.11	Herbal medicinal product	Information not present in EudraCT
D.3.11.12	Homeopathic medicinal product	Information not present in EudraCT
D.3.11.13	Another type of medicinal product	Information not present in EudraCT
D.IMP: 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 SA
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	Taxotere
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.3.8	INN - Proposed INN	docetaxel
D.3.9.1	CAS number	114977-28-5
D.3.9.3	Other descriptive name	Taxotere
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	20 to 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: 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	Dacortin
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Farma y Quimica, 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	Dacortin
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.3.8	INN - Proposed INN	prednisone
D.3.9.1	CAS number	53-03-2
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	5
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	Information not present in EudraCT
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Information not present in EudraCT
D.3.11.7	Plasma derived medicinal product	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	Information not present in EudraCT
D.3.11.11	Herbal medicinal product	Information not present in EudraCT
D.3.11.12	Homeopathic medicinal product	Information not present in EudraCT
D.3.11.13	Another type of medicinal product	Information not present in EudraCT

D.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

Metastatic hormone refractory(androgen independent) progressive prostate cancer (HRPC)

Cáncer de próstata progresivo metastásico resistente a hormonas (CPRH) (independiente de andrógenos)

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Objetivos principales
• Grupo A: Evaluar la eficacia, en lo que respecta a la tasa de respuestas del PSA, de dosis múltiples de CP 751,871 combinadas con docetaxel y prednisona en pacientes con CPRH que no han recibido nunca quimioterapia.
• Grupo B: Evaluar la eficacia, en lo que respecta a la tasa de respuestas del PSA, de CP 751,871 combinado con docetaxel y prednisona en pacientes con CPRH en los que progresa la enfermedad tras tratamiento con docetaxel/prednisona.

E.2.2

Secondary objectives of the trial

Objetivos secundarios
• Evaluar la seguridad y la tolerabilidad de dosis múltiples de CP 751,871 combinadas con docetaxel y prednisona.
• Evaluar la FC de población de CP-751,871 cuando se utiliza combinado con docetaxel y prednisona.
• Evaluar el efecto de CP 751,871 combinado con docetaxel y prednisona en los biomarcadores.
• Evaluar la aparición de la respuesta de anticuerpos antihumanos humanos (HAHA) a CP-751,871.
• Evaluar la eficacia en lo que respecta a la supervivencia sin progresión.
• Evaluar la idoneidad de utilizar cuestionarios del dolor y la calidad de vida en esta población de pacientes, y resumir sus características basales.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adenocarcinoma de próstata confirmado por examen histológico (no es necesario obtener una biopsia diagnóstica nueva).
2. 18 años de edad como mínimo.
3. PSA > 5 ng/ml.
4. Demostración de metástasis en la gammagrafía ósea o en la TC.
5. Progresión de la enfermedad tras 1 tratamiento hormonal (orquiectomía, estrógenos, tratamiento con LHRH, etc.) como mínimo, con concentraciones de testosterona documentadas inferiores a 50 ng/dl (equivalente a 1,7 nmol/l) y progresión de la enfermedad definida por cualquiera de las siguientes circunstancias:
• Elevación del PSA > 50 % con respecto al nadir durante el tratamiento hormonal, medido en 3 ocasiones sucesivas con 1 semana de diferencia como mínimo. Si el valor de la tercera medición es menor que el de la segunda, se obtendrá una cuarta. Sólo si la cuarta es mayor que la segunda, se reclutará al paciente.
• Progresión de la enfermedad según los criterios RECIST.
• Dos o más lesiones óseas nuevas.
6. Se necesita el uso simultáneo de un agonista de la LHRH, si el paciente no ha sido castrado quirúrgicamente.
7. Estado funcional según el Eastern Cooperative Oncology Group (ECOG) de 0, 1 o 2, medido en las 2 semanas previas a la inclusión (Apéndice E).
8. Recuperación a grado ≤ 1 de los CTCAE o considerado irreversible de los efectos del tratamiento del cáncer anterior. Se permitirán los AA de grado > 1 de los CTCAE cuando el promotor y el investigador consideren que no ponen en riesgo la seguridad.
9. Nivel de dolor estable al menos una semana antes del reclutamiento.
10. Recuento absoluto de neutrófilos ≥ 1,5 x 109/l y de plaquetas ≥ 100 x 109/l.
11. Parámetros de bioquímica sanguínea adecuados, medidos por:
• Creatinina ≤ 1,7 mg/dl (equivalente a 151 µmol/l). Si la creatinina es > 1,7 mg/dl, el aclaramiento de creatinina calculado deberá ser ≥ 40 ml/min con las fórmulas de Cockcroft Gault o MDRD (Apéndice D).
• Bilirrubina ≤ LSN.
• Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤ 1,5 x LSN
• Hemoglobina ≥ 10 g/dl.
12. El paciente entiende el consentimiento informado por escrito, y de forma voluntaria lo firma y fecha.

E.4

Principal exclusion criteria

1. Quimioterapia o radioterapia para el cáncer de próstata en el pasado.
2. Tratamientos experimentales anteriores con anti-IGF-1R y basados en anticuerpos. Otros tratamientos experimentales (dirigidos o vacunas), a menos que el investigador y el promotor acuerden otra cosa, necesitarán un período de lavado de 4 semanas antes del reclutamiento.
3. Tratamiento antiandrogénico (p. ej., flutamida) para un cáncer primario en las 4 semanas previas a la admisión (6 semanas en el caso de bicalutimida, nilutamida u otros antiandrógenos de acción prolongada).
4. Radioterapia de más del 25 % de la médula ósea (véase el Apéndice I).
5. Radiación local en las 2 semanas previas al reclutamiento.
6. Intervención quirúrgica en las 4 semanas previas al reclutamiento en el estudio, o recuperación incompleta de los efectos secundarios de procedimientos anteriores.
7. Uso de productos que afecten a las concentraciones del PSA en las 4 semanas previas al reclutamiento (p. ej., PC Calm, PC Plus, PC SPES, finasterida).
8. Cualquier trastorno médico o infección activa graves no controlados que mermarían la capacidad para recibir el tratamiento del estudio.
9. Cardiopatía activa significativa, como: hipertensión no controlada (es decir, presión arterial sistólica > 160 mm Hg, presión arterial diastólica > 95 mm Hg), angina inestable, trombosis venosa profunda, embolia pulmonar, ataque cerebrovascular, valvulopatía, insuficiencia cardíaca congestiva, infarto de miocardio en los 6 meses previos o arritmias cardíacas graves.
10. Pacientes que reciban tratamiento inmunodepresor prolongado con esteroides en dosis elevadas. 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). Se permite el tratamiento previo con esteroides, pero se suspenderá en el momento de inclusión. Se permite el uso de esteroides en dosis bajas para controlar las náuseas y los vómitos (p. ej., dexametasona 20 mg/día durante 5 días como máximo). Se permite el uso de esteroides tópicos. Se permite el uso de esteroides inhalados. El uso de dexametasona como premedicación no constituye un criterio de exclusión.
11. Reacciones de hipersensibilidad conocidas de carácter grave a docetaxel o a otros fármacos formulados con polisorbato 80.
12. Contraindicación médica para cualquiera de las premedicaciones de docetaxel.
13. Neuropatía de grado > 1 o indicios de síntomas neurológicos inestables en las 4 semanas previas al reclutamiento.
14. Metástasis cerebrales. Síntomas del sistema nervioso central (SNC) no evaluados e indicativos de metástasis cerebrales en las 2 semanas previas al reclutamiento. Los síntomas del SNC deberán evaluarse mediante tomografía computadorizada (TC) o resonancia magnética (RM).
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.
16. Pacientes en edad fértil que no utilicen métodos de barrera adecuados durante el tratamiento.
17. Tumor maligno activo aparte del cáncer de próstata en los 5 últimos años, a excepción del carcinoma cutáneo distinto del melanoma (basocelular o espinocelular)

E.5 End points

E.5.1

Primary end point(s)

La tasa de respuestas del PSA.

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

QoL

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

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Information not present in EudraCT

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

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

El final de ensayo en un Estado miembro de la Unión Europea se define como el momento en el que se considera que el número de sujetos que han sido incluidos y que han completado el ensayo es suficiente, según se indica en la solicitud presentada a las autoridades (ver punto 13 del protocolo)

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

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

F.4.2.2

In the whole clinical trial

120

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)

Todos los pacientes que reciban CP 751,871 se seguiran para evaluar la aparición de toxicidad aguda y tardia durante un periodo de 150 días desde la última dosis, a menos que el paciente retire el consentimiento o reciba otro tratamiento para su enfermedad. Las visitas de seguimiento se programarán una vez al mes. Se pueden concertar visitas de seguimiento adicionales para controlar acontecimientos adversos no resueltos o la eficacia.

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

2007-08-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-07-30

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-12-14

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