Clinical Trials Register

Summary
EudraCT Number:	2012-001991-13
Sponsor's Protocol Code Number:	PH-L19IL2TNF-02/12
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:	2012-07-26
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

2012-001991-13

A.3

Full title of the trial

A phase II study of intratumoral application of L19IL2/L19TNF in melanoma patients in clinical stage III or stage IV M1a with presence of injectable cutaneous and/or subcutaneous lesions.

Studio di fase II di applicazione intratumorale di L19IL2/L19TNF nei pazienti con melanoma in stadio clinico III o IV M1a con presenza di lesioni iniettabili cutanee e/o sottocutanee.

A.3.1

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

A phase II study of intratumoral application of L19IL2/L19TNF in melanoma patients in clinical stage III or stage IV M1a with presence of injectable cutaneous and/or subcutaneous lesions.

Studio di fase II di applicazione intratumorale di L19IL2/L19TNF nei pazienti con melanoma in stadio clinico III o IV M1a con presenza di lesioni iniettabili cutanee e/o sottocutanee.

A.3.2

Name or abbreviated title of the trial where available

Intratumoral administration of L19IL2/L19TNF

Somministrazione intratumorale di L19IL2/L19TNF

A.4.1

Sponsor's protocol code number

PH-L19IL2TNF-02/12

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	PHILOGEN S.P.A.
B.1.3.4	Country	Italy
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	Philogen S.P.A.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Philogen S.p.A.
B.5.2	Functional name of contact point	NA
B.5.3	Address:
B.5.3.1	Street Address	Localita' Bellaria n. 35
B.5.3.2	Town/ city	Sovicille (SI)
B.5.3.3	Post code	53018
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39-0577-588539
B.5.5	Fax number	+39-0577-1781690
B.5.6	E-mail	infotrial@philogen.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	tumor-targeting human L19TNFalpha monoclonal antibody-cytokinbe fusion protein
D.3.2	Product code	L19TNFalfa
D.3.4	Pharmaceutical form	Concentrate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intratumoral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	L19TNFa
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	208
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	anticorpo scFV di sintesi legato a TNFalfa
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	tumor-targeting human L19IL2 monoclonal antibody-cytokine fusion protein
D.3.2	Product code	L19IL2
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intratumoral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	L19IL2
D.3.10	Strength
D.3.10.1	Concentration unit	million IU million international units
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	13
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	anticorpo scFv di sintesi legato a IL2

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

Histologically-confirmed malignant melanoma of the skin with presence of injectable cutaneous and/or subcutaneous lesions either in clinical stage III or stage IV M1a.

Melanoma maligno della pelle da conferma istologica di stadio clinico III o IV M1a con presenza di lesioni iniettabili cutanee e/o sottocutanee.

E.1.1.1

Medical condition in easily understood language

Histologically-confirmed malignant melanoma of the skin with presence of injectable cutaneous and/or subcutaneous lesions either in clinical stage III or stage IV M1a.

Melanoma maligno della pelle da conferma istologica di stadio clinico III o IV M1a con presenza di lesioni iniettabili cutanee e/o sottocutanee.

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10025671
E.1.2	Term	Malignant melanoma stage IV
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10025670
E.1.2	Term	Malignant melanoma stage III
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

Efficacy of L19IL2/L19TNF-treated lesions measured as : Rate of patients with complete response (CR) of L19IL2/L19TNF-treated lesions at week 12 (day 85).

Efficacia del L19IL2/L19TNF sulle lesioni trattate, misurata in termini di: Tasso di pazienti con risposta completa (CR) di tutte le lesioni trattate con L19IL2/L19TNF alla settimana 12 (giorno 85).

E.2.2

Secondary objectives of the trial

Efficacy of L19IL2/L19TNF-treated lesions: 1)Objective response rate (Complete response CR and partial response PR) and disease control rate ( stable disease SD ) of L19IL2/L19TNF-treated lesions at week 12. Duration of objective response and disease control of L19IL2/L19TNF-treated lesions Efficacy of L19IL2/L19TNF- treated/non treated lesions: 2)Rate of patients with CR, PR and SD of all metastases at week 12, 24 and 36 (objective response rate according to RECIST v 1.1) 3) Duration of objective response and disease control of all metastases 4) Median overall survival (mOS). Safety of intratumoral administration of L19IL2/L19TNF.

Efficacia del L19IL2/L19TNF sulle lesioni trattate: 1)Tasso di risposta oggettiva (risposta completa CR e risposta parziale PR) e tasso di controllo della malattia (stabilizzazione della malattia SD) alla settimana 12 di trattamento delle lesioni con L19IL2/L19TNF. Durata della risposta oggettiva e controllo della malattia delle lesioni trattate con L19IL2/L19TNF. Efficacia del L19IL2/L19TNF sulle lesioni trattate/non trattate: 2)Tasso di pazienti con CR, PR e SD di tutte le metastasi alle settimane 12, 24 e 36 (tasso di risposta oggettiva in accordo ai criteri RECIST v 1.1). 3)Durata della risposta oggettiva e del controllo della malattia di tutte le metastasi. 4) Sopravvivenza mediana globale (mOS). Sicurezza della somministrazione intratumorale di L19IL2/L19TNF.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1)Histologically confirmed malignant melanoma of the skin in clinical stage III or stage IV M1a 2)Presence of measurable and injectable cutaneous and/or subcutaneous lesions 3)Males or females, age >/= 18 years 4)ECOG/WHO performance status </= 2 5)Life expectancy of at least 12 weeks 6)Absolute neutrophil count > 1.5 x 10^9/L 7)Hemoglobin > 9.0 g/dL 8)Platelets > 100 x 10^9/L 9)Total bilirubin </= 30 µmol/L (or </= 2.0 mg/dl) 10)ALT and AST </= 2.5 x the upper limit of normal (ULN) 11)Serum creatinine < 1.5 x ULN 12)LDH serum level within normal range 13)All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.02) Grade </= 1 unless otherwise specified above 14)Negative serum pregnancy test (for women of child-bearing potential only) at screening 15)If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug. 16)Able to provide written Informed Consent 17)Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

1)Melanoma maligno della pelle da conferma istologica di stadio clinico III o IV M1a. 2)Presenza di lesioni misurabili ed iniettabili cutanee e/o sottocutanee. 3)Maschi o femmine di età >/= 18 anni. 4)Valore del performance status ECOG/WHO </=2 5)Aspettativa di vita di almeno 12 settimane. 6)Conta assoluta dei neutrofili > 1.5 x 10^9/L. 7)Emoglobina > 9.0 g/dL. 8)Piastrine > 100 x 10^9/L. 9)Bilirubina totale </= 30 µmol/L (o di </= 2.0 mg/dl). 10)ALT e AST </= 2.5 volte il limite superiore del valore normale (ULN). 11)Creatina sierica < 1.5 volte del ULN. 12)Livelli sierici di LDH nel range di normalità. 13)Tutti gli effetti tossici (escluso l’alopecia) di qualsiasi precedente terapia devono essere risolti secondo il Common Terminology Criteria for Adverse Events (CTCAE, v4.02) del National Cancer Institute (NCI) di Grado </= 1 se non diversamente specificato sopra. 14)Test di gravidanza negativo allo screening (solamente per le donne in età fertile). 15)Se in età fertile, l’accordo di utilizzare adeguati metodi contraccettivi (ad esempio, contraccettivi orali, preservativi, o altri metodi di barriera adeguati, i dispositivi intrauterini anticoncezionali, la sterilizzazione), a partire dalla visita di screening e continuando fino a 3 mesi dopo l’ultimo trattamento con il farmaco in studio. 16)In grado di fornire consenso informato scritto. 17)Volontà e capacità di rispettare le visite in programma, il piano di trattamento, gli esami di laboratorio e le altre procedure di studio.

E.4

Principal exclusion criteria

1) Uveal melanoma and mucosal melanoma 2)Evidence of visceral metastases and/or active brain metastases at screening 3)Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively treated < 5 years prior to study entry 4)History of HIV infection or infectious hepatitis B or C 5)Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. 6)History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris. 7)Inadequately controlled cardiac arrhythmias including atrial fibrillation 8)Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria) 9)Uncontrolled hypertension 10)Ischemic peripheral vascular disease (Grade IIb-IV) 11)Severe diabetic retinopathy 12)Active autoimmune disease 13)History of organ allograft or stem cell transplantation 14)Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment. 15)Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies. 16)Breast feeding female 17)Anti-tumor therapy within 4 weeks of the administration of study treatment (except small surgery). 18)Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment. 19)Planned administration of growth factors or immunomodulatory agents within 7 days before the administration of study treatment 20)Patients in need of systemic treatment for rapidly progressive systemic disease. 21)Patient requires or is taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion. oAny conditions that in the opinion of the investigator could hamper compliance with the study protocol.

1)Melanoma uveale e delle mucose. 2) Evidenza, al momento dello screening, di metastasi viscerali e/o metastasi cerebrali attive. 3) Tumore precedente o concomitante distinto nel sito primario o dall’istologia del tumore valutato in questo studio, eccetto che il carcinoma in situ della cervice uterina, carcinoma basocellulare trattato, tumori superficiali della vescica (TA, Tis e Ti) o di qualsiasi forma di cancro trattato con intento curativo < 5 anni prima dell’inclusione nello studio. 4) Storia di infezione da HIV o da epatite infettiva B o C. 5) Presenza di infezioni attive (ad esempio, che necessitano di terapia antimicrobica) di altre gravi patologie concomitanti, che, a giudizio dell’ investigatore, potrebbero porre il paziente a rischi inutili o possono interferire con lo studio. 6) Storia, nel corso dell'ultimo anno, di sindromi coronariche acute o subacute, compreso l’infarto del miocardio, l’angina pectoris instabile o stabile severa. 7) Aritmie cardiache tra cui la fibrillazione atriale non adeguatamente controllabili 8) Insufficienza cardiaca (> Grade II, secondo i criteri del New York Heart Association (NYHA)). 9) Ipertensione non controllata. 10)Ischemia vascolare periferica (Grado IIb-IV). 11) Retinopatia diabetica grave. 12) Malattia autoimmune attiva. 13) Storia di trapianto d’organo allografico o di trapianto di cellule staminali. 14) Recupero da gravi traumi, compreso intervento chirurgico entro 4 settimane prima della somministrazione del trattamento in studio. 15) Storia conosciuta di allergia al IL2, TNF, o altre proteine umane/peptidi/anticorpi. 16) Allattamento. 17) Terapia antitumorale entro 4 settimane dalla somministrazione del trattamento in studio (eccetto piccolo intervento chirurgico). 18) Precedente esposizione in vivo ad anticorpi monoclonali per terapia biologica nelle 6 settimane prima della somministrazione del trattamento in studio. 19) Somministrazione prevista di fattori di crescita o agenti antitumorali nei 7 giorni prima della somministrazione del trattamento in studio. 20) Pazienti che necessitano di trattamento sistemico per la rapida progressione della malattia sistemica. 21)Paziente che richiede o che sta assumendo corticosteroidi o farmaci immunosoppressori a lungo termine. Non è considerato un criterio di esclusione l’uso limitato di corticosteroidi per trattare o prevenire le reazioni di ipersensibilità acuta. 22) Condizioni che, a giudizio dell’investigatore, potrebbero ostacolare la regolare esecuzione del protocollo dello studio.

E.5 End points

E.5.1

Primary end point(s)

Rate of patients with complete response (CR) of L19IL2/L19TNF- treated lesions at week 12 (day 85)

Tasso di pazienti con risposta completa (CR) di tutte le lesioni trattate con L19IL2/L19TNF alla settimana 12 (giorno 85).

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12 (85 days from treatment start)

Settimana 12 (85 giorni dall'inizio trattamento).

E.5.2

Secondary end point(s)

oObjective response rate (Complete response CR and partial response PR) and disease control rate ( stable disease SD ) of L19IL2/L19TNF-treated lesions at week 12. Duration of objective response and disease control of L19IL2/L19TNF-treated lesions. oRate of patients with CR, PR and SD of all metastases at week 12, 24 and 36 (objective response rate according to RECIST v 1.1) oDuration of objective response and disease control of all metastases oMedian overall survival (mOS) Safety of intratumoral administration of L19IL2/L19TNF.

oTasso di risposta oggettiva (risposta completa CR e risposta parziale PR) e tasso di controllo della malattia (stabilizzazione della malattia SD) alla settimana 12 di trattamento delle lesioni con L19IL2/L19TNF. Durata della risposta oggettiva e controllo della malattia delle lesioni trattate con L19IL2/L19TNF. oTasso di pazienti con CR, PR e SD di tutte le metastasi alle settimane 12, 24 e 36 (tasso di risposta oggettiva in accordo ai criteri RECIST v 1.1). oDurata della risposta oggettiva e del controllo della malattia di tutte le metastasi. oSopravvivenza mediana globale (mOS). Sicurezza della somministrazione intratumorale di L19IL2/L19TNF.

E.5.2.1

Timepoint(s) of evaluation of this end point

from 12 weeks until 1 year

12 settimane fino ad un anno

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

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

E.8.1.1

Randomised

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

Yes

E.8.1.7.1

Other trial design description

studio non randomizzato, multicentrico, prospettico.

uncontrolled, multicenter, prospective study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

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

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)

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

2012-09-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-05-26

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