Clinical Trials Register

Summary
EudraCT Number:	2016-003996-23
Sponsor's Protocol Code Number:	SAKK08/16
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:	2019-01-22
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

2016-003996-23

A.3

Full title of the trial

ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with novel hormonal agents and non-progressive disease after subsequent treatment with a taxane: A multicenter randomized double-blind placebo-controlled phase II trial

Tratamiento de mantenimiento con ODM-201 en pacientes con cáncer de próstata metastásico resistente a la castración (CPRCm) tratados previamente con nuevos agentes hormonales y enfermedad no progresiva después de recibir tratamiento posterior con un taxano: Estudio fase II, multicéntrico, aleatorizado, doble ciego y controlado con placebo

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

ODM-201 maintenance therapy in patients with mCRPC previously treated with novel hormonal agents

Tratamiento de mantenimiento con ODM-201 en pacientes con CPRCm tratados previamente con nuevos agentes hormonales

A.3.2

Name or abbreviated title of the trial where available

Protocol SAKK 08/16

A.4.1

Sponsor's protocol code number

SAKK08/16

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SAKK
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bayer HealthCare Pharmaceuticals Inc.
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SAKK
B.5.2	Functional name of contact point	Eloïse Kremer
B.5.3	Address:
B.5.3.1	Street Address	Effingerstrasse 33
B.5.3.2	Town/ city	Berna
B.5.3.3	Post code	CH - 3008
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41 31 508 42 11
B.5.5	Fax number	+41 31 389 92 00
B.5.6	E-mail	Eloise.Kremer@sakk.ch

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	ODM-201
D.3.2	Product code	ODM-201
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
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	DAROLUTAMIDE
D.3.9.2	Current sponsor code	BAY 1841788
D.3.9.3	Other descriptive name	DAROLUTAMIDE
D.3.9.4	EV Substance Code	SUB185326
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	300
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Metastatic castration resistant prostate cancer

Cáncer de próstata metastásico resistente a la castración (CPRCm)

E.1.1.1

Medical condition in easily understood language

Metastatic castration resistant prostate cancer

Cáncer de próstata metastásico resistente a la castración (CPRCm)

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10007453
E.1.2	Term	Carcinoma of the prostate metastatic
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane

El objetivo principal del estudio es evaluar el impacto del tratamiento de mantenimiento con ODM-201 sobre la supervivencia sin progresión radiográfica (SSPr) de los pacientes con CPRCm con tratamiento previo con nuevos agentes hormonales que no presentan enfermedad progresiva después de la quimioterapia con un taxano

E.2.2

Secondary objectives of the trial

• Radiographic progression-free survival (rPFS)
• Time to PSA progression
• Time to symptomatic/clinical progression
• Event-free survival
• Overall survival
• PSA response (30%, 50%, 90% and best)
• Duration of PSA response (50%)
• Adverse events
• Fatigue

• Supervivencia sin progresión radiográfica (SSPr)
• Tiempo hasta la progresión del PSA
• Tiempo hasta la progresión sintomática/clínica
• Supervivencia sin eventos
• Supervivencia global
• Respuesta del PSA (30 %, 50 %, 90 % y mejor respuesta)
• Duración de la respuesta del PSA (50 %)
• Acontecimientos adversos
• Cansancio

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
- Metastatic disease, documented by imaging
- Total testosterone ≤ 50 ng/dL (≤ 1.7 nmol/L)
- Treatment with abiraterone AND/OR enzalutamide for at least 8 weeks prior to taxane based chemotherapy
- No evidence of disease progression after chemotherapy with docetaxel (at least cumulative dose of ≥ 300 mg/m2 or total dose ≥600mg) or cabazitaxel (at least cumulative dose of ≥80 mg/m2 or total dose ≥160 mg)
o No evidence of progression on imaging1 according to PCWG3
o No evidence of progression on PSA levels referred to the nadir since start of taxane treatment (PSA progression defined as >25% increase of PSA level or >50% if PSA decrease under chemotherapy >50% AND > 5 ng/mL increase in the absolute PSA value)
- Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
- Planned start of trial treatment 2 to 8 weeks after last taxane dose
- Male patient 18 years or older
- WHO performance status of ≤2

- Diagnóstico de adenocarcinoma de próstata confirmado desde el punto de vista histológico o citológico.
- Resistencia a la castración: progresión del tumor tras la orquiectomía o durante el tratamiento con análogos de GnRH (agonistas o antagonistas)
- Enfermedad metastásica documentada mediante técnicas de diagnóstico por imagen
- Testosterona total ≤ 50 ng/dl (≤ 1,7 nmol/l)
- Tratamiento con abiraterona Y/O enzalutamida durante al menos 8 semanas antes de recibir quimioterapia basada en taxanos
- Sin indicios de progresión de la enfermedad después de la quimioterapia con docetaxel (al menos unadosis acumulada ≥ 300 mg/m2 o dosis total ≥ 600 mg) o cabazitaxel (al menos una dosis acumulada ≥ 80 mg/m2 o dosis total ≥ 160 mg)
o Ausencia de indicios de progresión en las pruebas de imagen según los PCWG3
o Ausencia de indicios de progresión de los niveles del PSA con respecto a la cifra mínima desde el inicio del tratamiento con taxanos (la progresión del PSA se define como un aumento del 25 % del nivel del PSA o > 50 % si la reducción del PSA con quimioterapia es > 50 % Y hay un aumento > 5 ng/ml en el valor absoluto del PSA)
- El paciente no castrado quirúrgicamente está de acuerdo con el uso continuado de análogos de GnRH (agonistas o antagonistas) durante el ensayo
- Inicio previsto del tratamiento del ensayo de 2 a 8 semanas después de la última dosis de taxano
- Varón de 18 años o más
- Estado funcional de la OMS ≤ 2

E.4

Principal exclusion criteria

- Prior chemotherapy for prostate cancer except from chemotherapy with a taxane
- Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
- Known CNS or leptomeningeal metastases
- Clinical or radiological evidence of current spinal cord compression
- Presence of a small cell component
- History of hematologic or primary solid tumor malignancy, unless in remission for at least 2 years from registration with the exception of localized non-melanoma skin cancer or carcinoma in situ having undergone complete resection.
- Prior therapy for mCRPC with modern anti-hormonal treatment except for enzalutamide or abiraterone
- Concurrent treatment with other experimental drugs
- Concomitant use of other anti-cancer drugs
- Severe or uncontrolled cardiovascular disease
- Acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before expected start of treatment
- Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information
- Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)

- Quimioterapia previa para el cáncer de próstata, excepto quimioterapia con un taxano
- Enfermedad concurrente que requirió dosis más altas de corticosteroides que el equivalente a 10 mg de prednisona al día.
- Metástasis conocidas leptomeníngeas o del SNC
- Hallazgos clínicos o radiológicos de compresión actual de la médula espinal
- Presencia de un componente microcítico
- Antecedentes de tumor maligno sólido primario o hematológico, a menos que estén en remisión durante al menos 2 años desde la inclusión, con la excepción del cáncer de piel no melanocítico o carcinoma in situ que haya sido sometido a una resección completa.
- Tratamiento previo para el CPRCm con tratamiento antihormonal moderno excepto con enzalutamida o abiraterona
- Tratamiento concomitante con otros fármacos experimentales
- Uso concomitante de otros fármacos antineoplásicos
- Enfermedad cardiovascular grave o no controlada
- Exacerbaciones agudas de enfermedades crónicas, infecciones graves o cirugía mayor en las 4 semanas previas al inicio previsto del tratamiento
- Cualquier fármaco concomitante contraindicado para su uso con los fármacos del ensayo según la información del medicamento autorizada.
- Hipersensibilidad conocida a los fármacos del estudio o a cualquier componente del fármaco del estudio

E.5 End points

E.5.1

Primary end point(s)

Radiographic progression-free survival (rPFS) at 12 weeks after treatment start

Supervivencia sin progresión radiográfica (SSPr) a las 12 semanas del inicio del tratamiento

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 semanas

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1 of each cycle

Día 1 de cada ciclo

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

Yes

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

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

Switzerland

E.8.7

Trial has a data monitoring committee

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

LVLS

UVUP

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

Number of subjects for this age range:

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.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Information not present in EudraCT

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

Information not present in EudraCT

F.3.3.6

Subjects incapable of giving consent personally

Information not present in EudraCT

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Patients will be treated according to the local clinical practice of the site

Los pacientes se tratarán de acuerdo a la práctica clinica habitual de cada centro

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

2019-02-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-31

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

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