Clinical Trials Register

Summary
EudraCT Number:	2012-000335-11
Sponsor's Protocol Code Number:	MK8669-064
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:	2012-08-02
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

2012-000335-11

A.3

Full title of the trial

A Phase 2 Randomized Trial of the Combination of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in High Proliferation, Estrogen Receptor Positive Breast Cancer Patients.

Studio randomizzato di fase II sulla combinazione di Ridaforolimus ed Exemestane in confronto a Ridaforolimus, Dalotuzumab ed Exemestane in pazienti con cancro alla mammella ad alta proliferazione e positività al recettore degli estrogeni.

A.3.1

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

A phase IIb study of ridaforolimus, dalotzumab and exemestane in combination in advanced breast cancer.

Studio di fase II b sulla combinazione di Ridaforolimus, Dalotuzumab ed Exemestane nel cancro alla mammella in fase avanzata.

A.3.2

Name or abbreviated title of the trial where available

A phase IIb study of ridaforolimus, dalotzumab and exemestane in combination in advanced breast canc

Studio di fase II b sulla combinazione di R/D/E

A.4.1

Sponsor's protocol code number

MK8669-064

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	MERCK SHARP & DOHME CORP.
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	MERCK SHARP & DOHME CORP.
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	MSD Italia S.r.l.
B.5.2	Functional name of contact point	Divisione Ricerca Clinica
B.5.3	Address:
B.5.3.1	Street Address	Via Fratelli Cervi, snc - Centro Direzionale Milano Due - Palazzo Borromini
B.5.3.2	Town/ city	Segrate (MI)
B.5.3.3	Post code	20090
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 21018402
B.5.5	Fax number	+39 02 21018629
B.5.6	E-mail	gcto.italy@merck.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	Ridaforolimus
D.3.2	Product code	MK-8669
D.3.4	Pharmaceutical form	Gastro-resistant 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	Ridaforolimus
D.3.9.1	CAS number	572924-54-0
D.3.9.2	Current sponsor code	MK-8669
D.3.9.3	Other descriptive name	Ridaforolimus
D.3.9.4	EV Substance Code	SUB32091
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	10
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.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	Dalotuzumab
D.3.2	Product code	MK-0646
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Dalotuzumab
D.3.9.1	CAS number	1005389-60-5
D.3.9.2	Current sponsor code	MK-0646
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	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	No
D.IMP: 3
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	Yes
D.2.1.1.1	Trade name	Exemestane 25mg Film-coated Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Actavis Group PTC ehf
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	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	EXEMESTANE
D.3.9.1	CAS number	107868-30-4
D.3.9.4	EV Substance Code	SUB07492MIG
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	25
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

ER positive, high proliferation breast.

Cancro alla mammella positivo al recettore degli estrogeni, localmente avanzato o metastatico, ad alta proliferazione.

E.1.1.1

Medical condition in easily understood language

Breast cancer.

Cancro alla mammella.

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	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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

The primary objective of the study is to evaluate the progression free survival (PFS) for the triplet combination of ridaforolimus, dalotuzumab and exemestane (R/D/E) compared to the combination of ridaforolimus and exemestane (R/E) in post-menopausal patients with high proliferation, estrogen receptor positive breast cancer that have progressed following treatment with a non-steroidal aromatase inhibitor.

L'obiettivo primario dello studio è valutare la sopravvivenza libera da progressione (PFS) per la triplice combinazione di ridaforolimus, dalotuzumab ed exemestane (R/D/E) rispetto alla combinazione di ridaforolimus ed exemestane (R/E) in pazienti in post-menopausa affette da cancro alla mammella ad alta proliferazione positivo al recettore degli estrogeni in cui si è verificata una progressione dopo il trattamento con un inibitore dell'aromatasi non steroideo. Ipotesi: La combinazione di R/D/E aumenterà la sopravvivenza libera da progressione rispetto a R/E.

E.2.2

Secondary objectives of the trial

In post-menopausal patients with high proliferation, estrogen receptor positive breast cancer who have progressed following treatment with a non-steroidal aromatase inhibitor, the secondary objectives of this trial are the following: • To evaluate the effectiveness of the triplet combination of ridaforolimus, exemestane and dalotuzumab (R/D/E) compared to ridaforolimus and exemestane (R/E) with respect to percent (%) reduction from baseline in the sum of imaging measurements (target lesion line lengths or volumetric images) at 16 weeks. • To evaluate the objective response rate, as measured by RECIST 1.1 of the triplet combination of R/D/E compared to the combination of R/E. • To estimate the overall survival for the triplet combination of R/D/E compared to the combination of R/E.

Nelle pazienti in post-menopausa affette da cancro alla mammella ad alta proliferazione positivo al recettore degli estrogeni, che hanno mostrato una progressione dopo il trattamento con inibitore dell'aromatasi non steroideo, gli obiettivi secondari di questa sperimentazione sono i seguenti: . Valutare l'efficacia della triplice combinazione di ridaforolimus, exemestane e dalotuzumab (R/D/E) rispetto a ridaforolimus ed exemestane (R/E) in base alla percentuale (%) di riduzione dal basale nella somma delle misure di imaging (diametri o volumi della lesione target )dopo 16 settimane. Valutare il tasso di risposta oggettiva, come misurato dal RECIST1 11 e della triplice combinazione di R/D/E rispetto alla combinazione R/E.Valutare la sopravvivenza totale per la triplice combinazione di R/D/E rispetto alla combinazione di R/E.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Metastatic, ER positive, HER2 negative Breast Cancer 2. High Proliferative (as measured by a Ki67 labeling index >15%) 3. Post menopausal 4. Previous treatment with either letrozole or anastrozole 5. AT least 1 measurable lesion 6. At least 18 years of age 7. Greater than or equal to 1 on the ECOG performance status. 8. Life expectance greater than 3 months

1. Cancro alla mammella metastatico positivo al recettore degli estrogeni e negativo ad HER2. 2. Ad alta proliferazione (come determinato dall'indice di marcatura Ki67 >15%.3. In post-menopausa. 4. Precedenti trattamenti con Letrozolo o Anastrozolo. 5. Almeno una lesione misurabile. 6. Almeno 18 anni di età. 7. Valutazione dello stato ECOG > 1. 8. Aspettativa di vita > di 3 mesi.

E.4

Principal exclusion criteria

1. Patient is on other therapy for their cancer (Bisphosphonates and denosumab for the treatment of bone metastases are allowed, if they were initiated at least 28 days prior to randomization.) 2. Patient is in another study or is receiving an experimental agent. 3. Patient has previously received rapamycin or rapamycin analogs, including ridaforolimus, temsirolimus, or everolimus. 4. Patient has received prior treatment with IGF-1R inhibitors, PI3K inhibitors, or other experimental agents that target PI3K, AKT, or mTOR pathway 5. Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks [(6 weeks for nitrosoureas, mitomycin C, or bevacizumab and 2 weeks for hormonal therapy and kinase inhibitors)] prior to entering the study or who has not recovered from adverse events from prior treatment to at least grade 1 or baseline. 6. Patient has active brain metastasis or leptomeningeal carcinomatosis; 7. Patient has poorly controlled Type 1 or 2 diabetes, defined as a hemoglobin A1C greater than 8% or a fasting glucose of > 160 mg/dL. 8. Patient is known to be HIV positive. 9. Patient has a known history of active Hepatitis B or C. Patients who are seropositive for Hepatitis B surface antibody as their only evidence of prior hepatitis exposure are allowed. 10. Patient has a requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A). Patients should be off these medications for at least 2 weeks prior to the first dose of ridaforolimus. Concomitant medications that are metabolized by CYP3A are allowed (e.g., simvastatin or atorvastatin). See Appendix 6.1 for examples of CYP3A inducers and inhibitors.

1. La paziente sta ricevendo un'altra terapia tumorale sistemica concomitante, inclusi agenti tumorali e inibitori HER-2. . Bifosfonati e denosumab per il trattamento delle metastasi ossee sono permessi, se sono stati iniziati prima della randomizzazione. 2. La paziente sta attualmente partecipando o ha partecipato ad uno studio con un composto o dispositivo sperimentale. 3. La paziente ha ricevuto in precedenza rapamicina o analoghi della rapamicina, incluso ridaforolimus, temsirolimus o everolimus. 4. La paziente ha ricevuto un trattamento precedente con inibitori IGF-1R, PI3K o altri agenti sperimentali che hanno come target la via metabolica PI3K, AKT o mTOR. 5. Una paziente che si sia sottoposta a chemioterapia, radioterapia o terapia biologica entro 4 settimane (6 settimane per nitrosouree, mitomicina C o bevacizumab e 2 settimane per una terapia ormonale e inibitori della chinasi) prima di entrare nello studio oppure che non abbia superato eventi avversi da un precedente trattamento ad almeno grado 1 o al basale. 6. La paziente ha un diabete di tipo 1 o 2 non pienamente controllato, definito come emoglobina A1C superiore all'8% o glucosio a digiuno > 160 mg/dl. 7. La paziente è positiva all'HIV. 8. La paziente ha un'anamnesi nota di epatite B o C attiva. Saranno idonee le pazienti che sono sieropositive per gli anticorpi contro l'antigene di superficie dell'epatite B come unica evidenza di precedente esposizione all'epatite. 8. La paziente ha necessità di un trattamento concomitante con medicinali che sono induttori o inibitori del citocromo P450 (CYP3A). Le pazienti devono aver interrotto questi medicinali da almeno 2 settimane prima della prima dose di ridaforolimus. Sono consentiti medicinali concomitanti che sono metabolizzati dal CYP3A (ad esempio simvastatina o atorvastatina). Vedere appendice 6.1 per esempi di induttori ed inibitori).

E.5 End points

E.5.1

Primary end point(s)

1. Progression Free Survival according to RECIST 1.1.

Sopravvivenza libera da progressione in accordo al RECIST 1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 8 calendar weeks while on treatment.

Ogni 8 settimane di calendario durante il trattamento.

E.5.2

Secondary end point(s)

1. Percent (%) change from baseline in the sum of target lesions by linear CT analysis at 16 weeks. 2. Percent (%) change from baseline in the sum of target lesions by tumor volume analysis at 16 weeks 3. Objective response rate, as measured by RECIST 1.1. 4. Overall survival will be assessed every 3 months.

1. Variazione in percentuale rispetto al basale nella somma delle lesioni bersaglio mediante analisi lineare CT a 16 settimane. 2. Variazione in percentuale rispetto al basale nella somma delle lesioni mediante analisi del volume tumorale a 16 settimane. 3. Tasso di risposta obiettiva misurato secondo RECIST 1.1. 4. La sopravvivenza globale sarà valutata ogni 3 mesi.

E.5.2.1

Timepoint(s) of evaluation of this end point

16 weeks for endpoints 1 and 2. Every 8 weeks for objective 3 every three months after disease progression.

16 settimane per il primo ed il secondo endpoint. Ogni 8 settimane per il terzo ogni 3 mesi dopo la progressione della malattia.

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)

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

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

Yes

E.8.2.3.1

Comparator description

Ridaforolimus-Exemestane

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

Brazil

Canada

Colombia

Israel

Korea, Republic of

Peru

Taiwan

United States

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 or; SPONSOR has right to terminate the study at any time. Reasons may include: quality or quantity of data recording is inaccurate or incomplete; poor adherence to protocol and regulatory requirements; the incidence or severity of adverse drug reaction in this or other studies indicates a potential health hazard to patients; plans to modify or discontinue the development of the study drug; or if study drug(s) is approved for marketing and available commercially. See protocol.

Lo Sponsor ha diritto a sospendere lo studio in qualsiasi momento.Le ragioni possono includere:registrazione dei dati mprecisa o incompleta;scarsa aderenza al protocollo ed ai requisiti normativi;incidenza o gravità delle reazioni avverse al farmaco

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

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

150

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)

n.a.

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

2012-09-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-03-15

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