Clinical Trials Register

Summary
EudraCT Number:	2016-000300-28
Sponsor's Protocol Code Number:	D081DC00007
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-05-25
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-000300-28

A.3

Full title of the trial

A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza¿) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer Who have Failed Prior Treatment with a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations

Studio di fase III, in aperto, randomizzato, per valutare l'efficacia e la sicurezza di Olaparib (Lynparza ¿) rispetto a Enzalutamide o Abiraterone acetato in uomini con cancro alla prostata metastatico resistente alla castrazione che hanno fallito un precedente trattamento con un nuovo agente ormonale e hanno mutazioni nel gene della riparazione per ricombinazione omologa

A.3.1

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

Study of Olaparib (Lynparza¿) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

A.3.2

Name or abbreviated title of the trial where available

PROfound

A.4.1

Sponsor's protocol code number

D081DC00007

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02987543

A.5.4

Other Identifiers

Name:

Number:

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	ASTRAZENECA SPA
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Clinical Trial Transparency
B.5.3	Address:
B.5.3.1	Street Address	Karlebyhus, Astraall¿n
B.5.3.2	Town/ city	Sodertalje
B.5.3.3	Post code	SE 151 85
B.5.3.4	Country	Sweden
B.5.4	Telephone number	00000000000
B.5.5	Fax number	000000000
B.5.6	E-mail	information.center@astrazeneca.com

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	olaparib
D.3.2	Product code	AZD2281
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	olaparib
D.3.9.1	CAS number	763113-22-0
D.3.9.2	Current sponsor code	AZD2281
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	100
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.IMP: 2
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	olaparib
D.3.2	Product code	AZD2281
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	olaparib
D.3.9.1	CAS number	763113-22-0
D.3.9.2	Current sponsor code	AZD2281
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	150
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.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	Xtandi 40mg - capsula molle -uso orale-blister (PVC/PCTFE/ALU) 112 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Xtandi
D.3.2	Product code	[Xtandi]
D.3.4	Pharmaceutical form	Capsule, soft
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	ENZALUTAMIDE
D.3.9.2	Current sponsor code	ENZALUTAMIDE
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	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)	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.IMP: 4
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	ZYTIGA - 250 MG - COMPRESSA - USO ORALE - FLACONE 120 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	JANSSEN-CILAG INTERNATIONAL N.V.
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Zytiga (abiraterone acetaye)
D.3.2	Product code	[Zytiga (abiraterone acetate)]
D.3.4	Pharmaceutical form	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	abiraterone acetato
D.3.9.2	Current sponsor code	abiraterone acetato
D.3.9.3	Other descriptive name	abiraterone acetate
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	250
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.IMP: 5
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	PREDNISONE - 10 CPR
D.2.1.1.2	Name of the Marketing Authorisation holder	BIOMEDICA FOSCAMA INDUSTRIA CHIMICO FARMACEUTICA S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Prednisone
D.3.2	Product code	[Prednisone]
D.3.4	Pharmaceutical form	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	PREDNISONE
D.3.9.2	Current sponsor code	PREDNISONE EG
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)	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

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

E.1.1.1

Medical condition in easily understood language

prostate cancer

cancro alla prostata

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the efficacy (as assessed by rPFS) of olaparib versus
investigator choice of enzalutamide or abiraterone acetate in men with
mCRPC with BRCA1, BRCA2 or ATM qualifying mutations (Cohort A)

Determinare l¿efficacia (valutata come rPFS) di olaparib rispetto alla scelta dello sperimentatore si enzalutamide o abiraterone acetato in pazienti con mCRPC con mutazioni qualificanti BRCA1, BRCA2 o ATM (coorte A)

E.2.2

Secondary objectives of the trial

to determine the efficacy of olaparib versus investigator choice of enzalutamide or abiraterone acetate in subjects with HRR qualifying gene mutattions measured by objective response rate in Cohort A, rPFS in Cohort A+B, time to pain progression in Cohort A and overall survivall in Cohort A

Determinare l¿efficacia (valutata dal ORR) di olaparib rispetto alla scelta dello sperimentatore di enzalutamide o abiraterone acetato in pazienti con mCRPC con mutazioni qualificanti BRCA1, BRCA2 o ATM (coorte A)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histologically confirmed diagnosis of prostate cancer.
2. Candidate for treatment with enzalutamide or abiraterone with
documented evidence of mCRPC.
3. Subjects must have progressed on prior new hormonal agent (e.g.
abiraterone acetate and/or enzalutamide) for the treatment of mCRPC.
4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
5. Radiographic progression at study entry while on androgen
deprivation therapy (or after bilateral orchiectomy).
6. Qualifying HRR mutation in tumor tissue by the Lynparza HRR Assay

Diagnosi confermata istologicamente di cancro alla prostata.
Essere candidato idoneo al trattamento con enzalutamide o arbitarone acetato con una storia documentata di cancro alla prostata metastatico resistente alla castrazione (mCRPC), dove lo stato metastatico è definito da almeno una lesione metastatica ossea documentata da scintigrafia ossea o TAC/RM. I soggetti la cui diffusione di malattia è limitata ai linfonodi della regione pelvica o con recidiva locale (vescica, retto…) non sono eleggibili.
I soggetti devono essere andati in progressione dopo somministrazione di un NAO per il trattamento del mCRPC.
Livelli di testosterone = 50 ng/dL (= 1.75 nmol/L) nei (=) 28 giorni precedenti alla randomizzazione.
Progressione radiografica all’entrata nello studio durante terapia di deprivazione androgenica (o dopo orchiectomia bilaterale
Presenza di mutazione HRR qualificante nei tessuti tumorali testata con LYNPARZA HRR Assay

E.4

Principal exclusion criteria

1. Any previous treatment with PARP inhibitor, including olaparib
2. Subjects who have any previous treatment with DNA-damaging
cytotoxic chemotherapy.
3. Other malignancy (including MDS and MGUS) within the last 5 years
except: adequately treated non-melanoma skin cancer or other solid
tumors curatively treated with no evidence of disease for =5 years.
4. Subjects with myelodysplastic syndrome/acute myeloid leukemia or
with features suggestive of MDS/AML.
5. *Subjects with known brain metastases.

Qualsiasi trattamento precedente con inibitori PARP, incluso olaparib
Soggetti che hanno ricevuto un precedente trattamento con chemioterapia citossica di danno al DNA.
Presenza di altre malattie maligne (incluso MDS e MGUS) negli ultimi 5 anni fatta eccezione per: cancro alla pelle non-melanoma adeguatamente trattato o altri tumori solidi compresi i linfomi (senza coinvolgimento del midollo osseo) liberi da malattia da = malattia.
Soggetti con sindrome mielodisplastica/leucemia mieloide acuta o con caratteristiche che suggeriscono MDS/AML.
Soggetti che presentano note metastasi cerebrali

E.5 End points

E.5.1

Primary end point(s)

Radiological Progression free survival (rPFS) by blinded independent central review (BICR) using RECIST 1.1. (soft tissue) and PCWG3 (bone) criteria

la valutazione radiografica della sopravvivenza libera da progressione (rPFS) in pazienti con mutazione BRCA1, BRCA2 o ATM (Coorte A).

E.5.1.1

Timepoint(s) of evaluation of this end point

At baseline and every 8 weeks (± 7 days), relative to the date of randomization, until objective radiological disease progression by BICR using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria

un’analisi primaria di rPFS basata su una risposta obiettiva tramite analisi BICR (coorte A), rPFS (combinando coorte A e B), tempo alla progressione del dolore (coorte A) e sopravvivenza globale (coorte A).

E.5.2

Secondary end point(s)

Confirmed ORR by BICR assessment in subjects with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria ; rPFS by BICR using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria; Pain progression based on BPI-SF item 3 "worst pain in 24 hours" and opiate analgesic use (AQA score) ; Overall survival

Conferma di overall response rate valutata da un comitato indipendente su soggetti con malattia misurabile utilizzando utilizzando i criteri Recist 1.1. (tessuti molli) e PCWG3 (ossa); Progressione libera da malattia valutata da un comitato etico indipendente utilizzando i criteri recist 1.1 (tessuti molli) e PCWG3 (ossa); La progressione del dolore basata sul questionario BPI-SF domanda 3 "peggior dolore in 24 h" e l'uso di analgesici-oppiacei (punteggio AQA); Sopravvivenza

E.5.2.1

Timepoint(s) of evaluation of this end point

At baseline and every 8 weeks (¿ 7 days), relative to the date of randomization, until objective radiological disease progression by BICR ; At baseline and every 8 weeks (¿ 7 days), relative to the date of randomization, until objective radiological disease progression by BICR; Subjects will complete the BPI-SF daily on the ePRO device for the 7 days just prior to day 1 baseline visit and every 4 weeks; The status of ongoing, withdrawn (from the study) and "lost to followup" subjects at the time of an overall survival analysis should be obtained by the site personnel by checking the subject notes, hospital records, contacting the subject's general practitioner and checking publicly available death registries

Ingresso dello studio e ongni 8 settimmane con una finestra di (¿ 7 giorni) a partire dalla randomizzazione del paziente e fino a oggettiva progressione di malattia; Ingresso dello studio e ongni 8 settimmane con una finestra di (¿ 7 giorni) a partire dalla randomizzazione del paziente e fino a oggettiva progressione di malattia; I pazienti completeranno il questionario BPI-SF quotidianamente sul diario elettronico per 7 giorni prima della visita di baseline e ogni 4 settimane; Lo stato di sopravvivenza dei pazienti ongoing, usciti dallo studio e lost to follow upal momento della analisi di sopravvivenza dovrebbe essere ottenuto dallo staff dello studio controllando i dati del paziente, le cartelle mediche contatttando il medico di medicina generale del paziente e controllando i registri

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

Yes

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)

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

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)

Yes

E.8.2.2

Placebo

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

190

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

Australia

Brazil

Canada

China

Israel

Japan

Korea, Republic of

United States

Austria

Denmark

France

Germany

Netherlands

Norway

Spain

Sweden

United Kingdom

Argentina

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

LSLV

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

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.1.2.1

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

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

245

F.4.2.2

In the whole clinical trial

340

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 end of treatment with study drug, patients should be managed
according to local standard of care.

Dopo la fine dello studio i pazienti saranno trattati secondo pratica clinica

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

2017-04-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-23

P. End of Trial
P.	End of Trial Status	Completed

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Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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