Clinical Trials Register

Summary
EudraCT Number:	2016-003996-23
Sponsor's Protocol Code Number:	SAKK08/16
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-11-07
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

Italy - Italian Medicines Agency

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 one novel hormonal agent first line and nonprogressive
disease after second line treatment with a taxane:
A multicenter randomized double-blind placebo-controlled phase II trial

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

Terapia di mantenimento con ODM-201 in pazienti con carcinoma della prostata avanzato precedentemente trattati con un agente ormonale innovativo

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
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 41 51
B.5.5	Fax number	41 31 389 92 00
B.5.6	E-mail	Andrea.Fuhrer@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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	BAY 1841788
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	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	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

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

Cancro prostatico metastatico resistente alla castrazione

E.1.1.1

Medical condition in easily understood language

Metastatic castration resistant prostate cancer

Cancro metastatico della prostata resistente alla castrazione

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

Valutare l’impatto di una terapia di mantenimento con ODM-201sull’intervallo libero da progressione radiografica (rPFS) in pazienti con mCRPC pretrattati con un agente ormonale innovativo, che non presentino progressione della malattia dopo trattamento chemioterapico con taxane

E.2.2

Secondary objectives of the trial

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 OR enzalutamide for at least 8 weeks prior to taxane based chemotherapy
 No evidence of disease progression after chemotherapy with docetaxel (cumulative dose of ≥ 450 mg/m2 or total dose ≥900mg) or cabazitaxel
(cumulative dose of ≥120 mg/m2 or total dose ≥204 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

• Diagnosi di adenocarcinoma prostatico con conferma istologica o citologica;
• Resistenza alla castrazione: progressione del tumore dopo orchiectomia o nel corso di trattamento con analoghi del GnRH (agonisti o antagonisti);
• Presenza di metastasi, documentata da diagnostica per immagini;
• Testosterone totale ≤ 50 ng/dL (≤ 1.7 nmol/L);
• Trattamento con abiraterone O enzalutamide per almeno 8 settimane prima della chemioterapia con taxane;
• Nessuna evidenza di progressione della malattia dopo chemioterapia con docetaxel (dose cumulativa di ≥ 450 mg/m2 o dose totale ≥900mg) o cabazitaxel (dose cumulativa di ≥120 mg/m2 o dose totale ≥204 mg):
o Nessuna evidenza di progressione della malattia documentata da diagnostica per immagini in linea con PCWG3;
o Nessuna evidenza di progressione della malattia documentata dai livelli di PSA relativi al valore di nadir del PSA dall’inizio del trattamento con taxane (la progressione di PSA è definita come un aumento>25% dei livelli di PSA o un aumento >50% se i livelli di PSA diminuiscono in corso di chemioterapia >50% E un aumento > 5 ng/mL dei valori assoluti di PSA);
• Pazienti non-chirurgicamente castrati che accettino di continuare il trattamento con analoghi del GnRH (agonisti o antagonisti) nel corso dello studio;
• Inizio del trattamento in studio pianificato tra le 2 e le 8 settimane dopo l’ultima somministrazione di taxane;
• Pazienti maschi di 18 anni o più anziani;
• Performance status di WHO ≤2.

E.4

Principal exclusion criteria

 Prior chemotherapy for prostate cancer except from chemotherapy with a taxane
 Retreatment with a taxane for metastatic castration resistant prostate cancer after interruption of > 8 weeks
 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)

• Precedenti chemioterapie per il cancro della prostata, tranne la chemioterapia con un taxane;
• Un ulteriore trattamento con un taxane, per carcinoma prostatico metastatico resistente alla castrazione, dopo un’interruzione > alle 8 settimane;
• Malattie in corso che richiedono dosi corticosteroidi superiori all'equivalente di prednisone di 10 mg al giorno;
• Note metastasi al SNC o alle leptomeningi;
• Evidenze cliniche o radiologiche di compressione in essere del midollo spinale;
• Presenza di componenti a piccole cellule;
• Storia di neoplasie ematologiche o di tumori solidi primari, a meno che non siano in remissione da almeno 2 anni dalla registrazione ad eccezione del carcinoma localizzato della pelle non-melanoma o del carcinoma in situ che abbiano subito una completa resezione;
• Precedente terapia di mCRPC con un moderno trattamento anti-ormonale ad eccezione di enzalutamide o abiraterone;
• Trattamento in corso con altri farmaci sperimentali;
• Uso concomitante di altri farmaci anti-tumorali;
• Malattia cardiovascolare grave o non controllata;
• Riacutizzazione di malattie croniche, infezioni gravi o interventi chirurgici importanti entro le 4 settimane precedenti il previsto inizio del trattamento;
• Qualsiasi terapia concomitante che abbia controindicazioni all’uso dei prodotti in studio in base alle informazioni approvate per il prodotto;
• Nota ipersensibilità al prodotto/i in studio o a qualsiasi componente di detto prodotto/i.

E.5 End points

E.5.1

Primary end point(s)

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

Determinare l’intervallo di tempo libero da progressione radiografica (rPFS) dopo 12 settimane dall’inizio del trattamento

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

E.5.2

Secondary end point(s)

Fatigue

Affaticamento

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1 of each cycle

1° giorno di ciascun 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

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

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

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

I pazienti saranno trattai in accordo alla pratica clinica locale del 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

2017-08-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-21

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-11-15

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IMP with orphan designation in the indication
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