Clinical Trials Register

Summary
EudraCT Number:	2005-005595-33
Sponsor's Protocol Code Number:	FE200486 CS21
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:	2006-02-16
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

2005-005595-33

A.3

Full title of the trial

Estudio abierto, multicéntrico, aleatorizado y de grupos paralelos, para investigar la eficacia y la seguridad de pautas de tratamiento mensuales con degarelix; 160 mg (40 mg/ml) y 80 mg (20 mg/ml), en comparación con LUPRON DEPOT® 7,5 mg en pacientes con cáncer de próstata que precisan ablación androgénica

A.4.1

Sponsor's protocol code number

FE200486 CS21

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	Ferring Pharmaceuticals A/S
B.1.3.4	Country	Denmark
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	Information not present in EudraCT
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	Degarelix
D.3.2	Product code	FE200486
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Degarelix
D.3.9.1	CAS number	214766-78-6
D.3.9.3	Other descriptive name	FE200486
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	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	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	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	Information not present in EudraCT
D.2.1.1.1	Trade name	LUPRON DEPOT®
D.2.1.1.2	Name of the Marketing Authorisation holder	TAP Pharmaceuticals Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	LUPRON DEPOT®
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Leuprorelide acetate
D.3.9.2	Current sponsor code	Lupron Depot
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	7.5
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)	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	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	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	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	Information not present in EudraCT
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	Degarelix
D.3.2	Product code	FE200486
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Degarelix
D.3.9.1	CAS number	214766-78-6
D.3.9.3	Other descriptive name	FE200486
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	40
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	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	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

Cáncer de Próstata

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	7.0
E.1.2	Level	pr t
E.1.2	Classification code	10060862

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:
•Demostrar la no inferioridad en cuanto al porcentaje de pacientes que alcanzan y mantienen la supresión de la testosterona en niveles de castración utilizando una pauta de tratamiento con degarelix en comparación con LUPRON DEPOT® 7,5 mg durante 12 meses de tratamiento.

E.2.2

Secondary objectives of the trial

Objetivos secundarios:
• Comparar los niveles séricos de testosterona y el PSA utilizando una pauta de tratamiento con degarelix frente a LUPRON DEPOT® 7,5 mg durante los primeros 28 días de tratamiento.

• Comparar la seguridad y la tolerabilidad utilizando una pauta de tratamiento con degarelix frente a LUPRON DEPOT® 7,5 mg.

• Comparar la respuesta de testosterona, LH, FSH y PSA utilizando una pauta de tratamiento con degarelix frente a LUPRON DEPOT® 7,5 mg durante todo el periodo de tratamiento.

• Comparar los Resultados Comunicados por el Paciente (Calidad de Vida y sofocos) utilizando una pauta de tratamiento con degarelix frente a LUPRON DEPOT® 7,5 mg durante el tratamiento.

• Evaluar la farmacocinética utilizando una pauta de tratamiento con degarelix.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

Cada paciente deberá cumplir los siguientes criterios de inclusión antes de entrar en el estudio:

1. El paciente ha otorgado su consentimiento informado por escrito antes de la práctica de cualquier actividad relacionada con el estudio. Se define como actividad relacionada con el estudio todo procedimiento que no se hubiera realizado en la práctica habitual del paciente.

2. El paciente presenta un adenocarcinoma de próstata (todos los estadíos) confirmado histológicamente (grados de Gleason), en el que está indicada la ablación androgénica, exceptuando la hormonoterapia neoadyuvante. Ello comprende a los pacientes con elevación del PSA tras haber sido sometidos a prostatectomía o radioterapia con intención curativa.

3. El paciente es un varón de edad igual o superior a 18 años.

4. Presenta un nivel de testosterona sérica en la selección > 1,5 ng/mL .

5. Presenta una puntuación del ECOG (Eastern Cooperative Oncology Group) ≤ 2.

6. Presenta un valor de PSA en la selección ≥ 2 ng/mL.

7. Presenta una esperanza de vida de como mínimo 12 meses.

E.4

Principal exclusion criteria

No podrá entrar en el estudio todo paciente que cumpla uno o más de los siguientes criterios de exclusión:

1. Ha sido sometido previamente o se encuentra actualmente bajo tratamiento o manipulación hormonal del cáncer de próstata (castración quirúrgica u otra manipulación hormonal, incluidos los agonistas del receptor de la LHRH, los antagonistas del receptor de la GnRH, los antiandrógenos y los estrógenos). Sin embargo, se aceptan los pacientes sometidos a prostatectomía o radioterapia con intención curativa, o a hormonoterapia neoadyuvante/adyuvante con una duración máxima de 6 meses. Dicho tratamiento deberá haber terminado como mínimo 6 meses antes de la Visita de Selección.

2. Se encuentra actualmente en tratamiento con un inhibidor de la 5-α-reductasa.

3. Se considera candidato para tratamiento curativo, es decir, prostatectomía radical o radioterapia.

4. Presenta historia de asma severa no tratada, reacciones anafilácticas o urticaria y/o angioedema severos.

5. Presenta hipersensibilidad a cualquier componente de los productos en investigación (véase la sección 6.2 del protocolo, Medicamentos en Investigación)

6. Presenta una prolongación marcada del intervalo QT/QTc en el momento basal (demostración repetida de un intervalo QTc > 450 mseg).

7. Historia de factores de riesgo adicionales de arritmia ventricular del tipo de Torsade de Pointes (por ejemplo, insuficiencia cardiaca, hipopotasemia, historia familiar de síndrome de QT largo).

8. Uso de medicamentos concomitantes que prolonguen el intervalo QT/QTc.

9. Ha padecido un cáncer en el plazo de los cinco últimos años, excepto el cáncer de próstata y el carcinoma cutáneo de células basales o escamosas resecado quirúrgicamente.

10. Presenta o se sospecha enfermedad hepática o biliar sintomática (lo que incluye la hepatopatía crónica de grado moderado a severo)

11. Presenta unos niveles séricos de ALT elevados por encima del límite superior de la normalidad o una bilirrubina total sérica por encima del límite superior de la normalidad, en su medición por el laboratorio en la Visita de Selección y con confirmación mediante una segunda medición en el plazo de 21 días.

12. Presenta otras anomalías de laboratorio clínicamente significativas que, a criterio del investigador, podrían interferir en la participación del paciente en el estudio o en la evaluación de los resultados del estudio.

13. Presenta una enfermedad clínicamente significativa (distinta del cáncer de próstata) o cualquier otro proceso, incluido el alcoholismo o la drogadicción, que pudiera interferir en la participación en el ensayo o que pudiera afectar a las conclusiones del estudio a criterio del investigador.

14. Presenta una incapacidad mental o problemas de idioma que impida la comprensión o colaboración adecuadas.

15. Ha recibido un fármaco en fase de investigación en el plazo de los 28 días previos a la Visita de Selección o en un plazo mayor si se considerara que pudiera influir sobre los resultados del presente estudio.

16. Ha participado previamente en otro estudio con degarelix.

E.5 End points

E.5.1

Primary end point(s)

Variable principal de la eficacia:

• Porcentaje de pacientes con niveles de testosterona ≤ 0,5 ng/mL desde el Día 28 al Día 364.

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

Information not present in EudraCT

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

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.8.5

The trial involves multiple Member States

Yes

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

Las evaluaciones de Fin del Estudio tendrán lugar después de los 364 días o lo antes posible después de que se haya tomado la decisión de retirar al paciente del estudio.

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	No
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Information not present in EudraCT
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
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	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	48
F.4.2	For a multinational trial
F.4.2.1	In the EEA	120
F.4.2.2	In the whole clinical trial	540

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

2006-03-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-03-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2007-10-08

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