Clinical Trials Register

Summary
EudraCT Number:	2015-000287-34
Sponsor's Protocol Code Number:	ARO-012
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-12-16
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

2015-000287-34

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Trial of Crenolanib in Subjects with Advanced or Metastatic Gastrointestinal Stromal Tumors with a D842V Mutation in the PDGFRA Gene.

Uno Studio Randomizzato, in doppio cieco, controllato con Placebo, Multicentrico di Crenolanib in Soggetti con Carcinomi Stromali Gastrointestinali Avanzati o con Metastasi con una Mutazione D842V del Gene PDGFRA

A.3.1

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

Study at several locations, randomized, double-blind with crenolanib in comparison with placebo in patients with advanced or metastatic gastrointestinal stromal tumors with a specific mutation (D842V) in the PDGFRA gene.

Studio in diverse localit¿, randomizzato, in doppio cieco con crenolanib rispetto al placebo nei pazienti con carcinomi stromali gastrointestinali avanzati o con metastasi con una mutazione specifica (D842V) del gene PDGFRA.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

ARO-012

A.5.4

Other Identifiers

Name:

IND Number

Number:

067968

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	AROG PHARMACEUTICALS, INC.
B.1.3.4	Country	United States
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	Arog Pharmaceuticals, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Arog Pharmaceuticals, Inc.
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	5420 LBJ Freeway, Suite 410
B.5.3.2	Town/ city	Dallas, TX
B.5.3.3	Post code	75240
B.5.3.4	Country	United States
B.5.6	E-mail	vjain@arogpharma.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	Crenolanib
D.3.2	Product code	AR-868,596-26
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	Crenolanib Besylate
D.3.9.1	CAS number	670220-93-6
D.3.9.2	Current sponsor code	AR-868,596-26
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	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)	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	Crenolanib
D.3.2	Product code	AR-868,596-26
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	Crenolanib Besylate
D.3.9.1	CAS number	670220-93-6
D.3.9.2	Current sponsor code	AR-868,596-26
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.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
D.8 Placebo: 2
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

Advanced or metastatic gastrointestinal stromal tumor (GIST)

Carcinomi stromali gastrointestinali avanzati o con metastasi

E.1.1.1

Medical condition in easily understood language

Tumor of the gastrointestinal tract

Tumore del tratto gastrointestinale

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10062427
E.1.2	Term	Gastrointestinal stromal tumor
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the treatment effect of crenolanib with that of placebo on prolonging progression-free survival (PFS) in subjects with advanced or metastatic GIST with a PDGFRA D842V mutation.

Confrontare l'effetto del trattamento di crenolanib con quello di placebo sulla sopravvivenza senza progressione prolungata in soggetti con GIST avanzato o con metastasi con una mutazione D842V PDGFRA.

E.2.2

Secondary objectives of the trial

To compare the treatment effect of crenolanib with that of placebo on overall survival (OS) and objective response rate (ORR).

Confrontare l'effetto del trattamento di crenolanib con quello di placebo sulla sopravvivenza globale (OS) e il tasso di risposta oggettivo (ORR).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
2. Measurable disease as per modified RECIST 1.1
- A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
3. Disease progression per modified RECIST 1.1 within 6 months of randomization
4. Subjects (male or female) = 18 years of age
5. Adequate bone marrow function, defined as:
- ANC of = 1000 /µL
- Platelet count of = 75 x 10^9/L
6. Adequate hepatic function, defined as:
- Serum total bilirubin within normal limits
- Serum aspartate aminotransferase (AST) = 2.0 x upper limit of normal (ULN)
- Serum alanine aminotransferase (ALT) = 2.0 x ULN
7. Adequate renal function, defined as:
- Serum creatinine = 1.5 x ULN or
- Creatinine clearance estimate of = 50 mL/min (as calculated according to Cokcroft-Gault formula or MDRD formula for subjects > 65 years).
8. Female subjects with reproductive potential must have negative serum or urine pregnancy test
Female subjects who meet at least one of the following criteria are defined as women of non-reproductive potential:
- =50 years old and naturally amenorrheic for = 1 year
- Permanent premature ovarian failure confirmed by a gynecologist
- Previous bilateral salpingo-oophorectomy
- XY genotype, Turner's syndrome, or uterine agenesis
9. Prior treatment with imatinib, sunitinib, regorafenib, dasatinib and/or nilotinib is allowed. Recovered from prior treatment-related toxicity to Grade = 2 per CTCAE v4.03 or the subject's baseline preceding the prior treatment.
10. Eastern Cooperative Oncology Group (ECOG) performance status of = 2
11. Adequate contraception:
- Female subjects with reproductive potential in combination with their partner must use 2 forms of highly effective methods of contraception during study treatment and for at least 30 days after ending treatment
- Male subjects in combination with their partner must use 2 forms of highly effective methods of contraception during study treatment and for at least 90 days after ending treatment
12. Written informed consent before any study-specific procedure is performed

1. GSIT avanzato o con metastasi confermato a livello istologico o citologico con una mutazione D842V nel gene PDGFRA come determinato dagli esperimenti di laboratorio centrale
2. Malattia misurabile secondo il RECIST 1.1 modificato
- Una lesione in un'area che è stata precedentemente trattata con terapia locale (ad es. radiazione, chirurgia o crioterapia) può essere considerata una malattia misurabile finché c'è evidenza oggettiva dell'avanzamento della malattia prima della randomizzazione
3. Progressione della malattia secondo il RECIST 1.1 modificato entro 6 mesi dalla randomizzazione
4. Soggetti (maschio o femmina) = 18 anni di età entro la data della firma del modulo di consenso informato
5. Adeguata funzione del midollo osseo, definita come:
- ANC di = 1000 /µL
- Conteggio piastrine di = 75 x 109/L
6. Adeguata funzione epatica, definita come:
- Bilirubina totale nel siero entro i normali limiti di ciascun ente
- Aspartate aminotransferase nel siero (AST) = 2.0 x limite superiore di normale (ULN)
- Alanina amminotransferasi nel siero (ALT) = 2.0 x ULN
7. Adeguata funzione renale, definita come:
- Creatinina nel siero = 1.5 x ULN o
- Valutazione dell'eliminazione della creatina di = 50 mL/min (come calcolato secondo la formula Cokcroft-Gault o la formula MDRD per soggetti > 65 anni).
8. I soggetti femminili con potenziale riproduttivo devono riportare analisi del siero o test di gravidanza delle urine negativi
I soggetti femminili che soddisfano almeno uno dei seguenti criteri sono definiti come donne non in età fertile:
- = 50 anni e naturalmente amenorreiche per = 1 anno
- Insufficienza ovarica prematura permanente confermata da un ginecologo
- Precedente salpingo-ovarectomia bilaterale
- Genotipo XY, sindrome di Turner o agenesia di utero
9. È consentito precedente trattamento con imatinib, sunitinib, regorafenib, dasatinib e/o nilotinib. Ripresa da precedente tossicità relative al trattamento al grado = 2 per CTCAE v4.03 o base del soggetto precedente al trattamento
10. Stato di prestazione del gruppo di oncologia cooperativa dell'est (ECOG) di = 2
11. Adeguata contraccezione:
- I soggetti femminili con potenziale riproduttivo in combinazione con il loro partner devono usare 2 forme di metodi contraccettivi altamente efficaci durante il trattamento dello studio e per almeno 30 giorni dopo aver terminato il trattamento
- I soggetti maschi in combinazione con il loro partner devono usare 2 forme di metodi contraccettivi altamente efficaci durante il trattamento dello studio e per almeno 90 giorni dopo aver terminato il trattamento
12. La firma del consenso informato scritto prima di qualsiasi procedura specifica dello studio è eseguita

E.4

Principal exclusion criteria

1. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
2. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Active infection with HBV is defined as:
o Acute hepatitis B (diagnosed < 6 months prior to randomization), or
o Serologic test positive for HBV surface antigen (HBsAg) positive, or
o Serologic test positive for immunoglobulin (IgM) to HBV core antigen (IgM anti-HBc)
- Active infection with HCV is defined as:
o Acute hepatitis C (diagnosed < 6 months prior to randomization), or
o Positive for HCV ribonucleic acid (RNA)
Subjects with history of positive anti-HCV screening test (e.g. enzyme immune-assay [EIA], chemiluminescence immunoassay [CIA], or recombinant immunoblot assay [RIA]) should be tested for HCV RNA
3. History of other malignancy within the past 3 years, except:
- Malignancy treated with curative intent and with no evidence of disease and considered to be at low risk of recurrence by the treating physician
- Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease
- Adequately treated cervical carcinoma in situ with no evidence of disease
- Adequately treated breast ductal carcinoma in situ with no evidence of disease
- Adequately treated prostatic intraepithelial neoplasia with no evidence of disease
- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ with no evidence of disease
4. Any disorder that compromises the subject's ability to give written informed consent and/or to comply with study procedures
5. Any severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator, may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results
6. Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
7. Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug's halflife in subject is known) prior to randomization, whichever is shorter
8. Prior administration of crenolanib

1. Malattia epatica grave (ad es. cirrosi, steatosi non alcolica, colangite sclerosante)
2. Infezione conosciuta, attiva con virus dell'epatite B (HBV) o epatite C (HCV)
- L'infezione attiva con HBV è definita come:
o Epatite B acuta (diagnosticata < 6 mesi prima della randomizzazione), oppure
o Test sierologico positivo per l'antigene di superficie HBV (HBsAg) positivo, oppure
o Test sierologico positivo per immunoglobulina (IgM) all'antigene del nucleo HBV (IgM anti-HBc)
- L'infezione attiva con HCV è definita come:
o Epatite C acuta (diagnosticata < 6 mesi prima della randomizzazione), oppure
o Positiva per acido ribonucleico HCV (RNA)
I soggetti con storia di test di screening anti-HCV positivo (ad es. immunodosaggio enzimatico [EIA], immunodosaggio chemiluminescenza [CIA] o dosaggio blot ricombinato [RIA]) devono essere testati per HCV RNA
3. Storia di altre malattie negli ultimi 3 anni, eccetto:
- La malattia trattata con intento curativo e senza evidenza di malattia e considerata a basso rischio di recidiva dal medico
- Carcinoma della pelle non melanoma o lentigo maligna tratti in modo adeguato senza evidenza della malattia
- Carcinoma cervicale trattato in modo adeguato in situ senza evidenza della malattia
- Carcinoma duttale al seno trattato in modo adeguato in situ senza evidenza della malattia
- Neoplasia intraepiteliale prostatica trattata in modo adeguato in situ senza evidenza della malattia
- Carcinoma non invasivo papillifero uroteliale trattato in modo adeguato in situ senza evidenza della malattia
4. Qualsiasi disturbo che compromette l'abilità del soggetto a dare consenso informato scritto e/o a conformarsi alle procedure dello studio
5. Qualsiasi condizione medica o fisica grave e/o non controllata che secondo il ricercatore può ostacolare il soggetto nel completamento dello studio, interferire con la valutazione della sicurezza e/o efficacia o interferire con l'interpretazione dei risultati dello studio
6. Soggetto femmina incinta o in età fertile o che sta programmando di rimanere incinta entro 30 giorni dopo la fine del trattamento
7. Trattamento antitumorale sistemico (ad es. chemioterapia, inibitori della chinasi della tirosina, immunoterapia o agenti sperimentali) o dispositivo di sperimentazione entro 3 settimane o 5 emivite (se l'emivita del farmaco in oggetto è conosciuta) prima della randomizzazione, a seconda di quale è applicato prima
8. Precedente somministrazione di crenolanib

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS)

Sopravvivenza senza progressione (PFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

35 months

35 mesi

E.5.2

Secondary end point(s)

Overall survival; Objective response rate (based on modified RECIST 1.1)

Sopravvivenza globale (OS); Tasso di risposta oggettivo (ORR) (in base al RECIST 1.1 modificato)

E.5.2.1

Timepoint(s) of evaluation of this end point

35 months;
35 months

35 mesi; 35 mesi

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

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

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

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

France

Germany

Italy

Norway

Poland

Spain

Switzerland

United Kingdom

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

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.1.1.1

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

Yes

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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)

After finishing all study relevant procedures, therapy and follow-up period, the patient will be followed in terms of routine aftercare and treated if necessary by the primary responsible hematology/oncology center.

Dopo aver terminato tutte le procedure rilevanti di studio, la terapia e follow-up, il paziente sar¿ seguito in termini di post-terapia di routine e trattata, se necessario, il principale responsabile del centro di ematologia / oncologia.

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

2017-01-16

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	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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