Clinical Trials Register

Summary
EudraCT Number:	2012-002464-27
Sponsor's Protocol Code Number:	IEOS707/412
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:	2023-12-27
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-002464-27

A.3

Full title of the trial

Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients with solid tumors metastatic or relapsed, resistant/refractory to conventional therapy, using HLA-identical related donors or HLA-Haploidentical related donors

Trapianto non mieloablativo di cellule staminali emopoietiche per pazienti con tumori solidi metastatici o recidivati, resistenti/refrattari alle terapie convenzionali, utilizzando donatori familiari HLA identici o donatori familiari HLA aploidentici

A.3.1

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

Blood Stem Cell transplantation with low dose chemo/radiotherapy for patients with High-Risk solid tumors using related identical donors or 50% compatible donors

Trapianto di cellule staminali del sangue con basse dosi di chemio/radioterapia per pazienti con tumori solidi ad alto rischio utilizzando donatori familiari totalmente compatibili o compatibili per il 50%.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

IEOS707/412

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	ISTITUTO EUROPEO DI ONCOLOGIA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Istituto Europeo di Oncologia
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Istituto Europeo di Oncologia
B.5.2	Functional name of contact point	Regulatory Affairs - CTO
B.5.3	Address:
B.5.3.1	Street Address	Via Ripamonti 435
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20141
B.5.4	Telephone number	0294372733
B.5.6	E-mail	raffaella.ghisini@ieo.it

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	na
D.3.2	Product code	na
D.3.4	Pharmaceutical form	Powder for solution for injection
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	CICLOFOSFAMIDE
D.3.9.1	CAS number	50-18-0
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB06859MIG
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	200
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	Yes
D.2.1.1.1	Trade name	ENDOXAN BAXTER*INIET 1FL 500MG
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER SpA
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.3.4	Pharmaceutical form	Powder for solution for injection
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	CICLOFOSFAMIDE
D.3.9.1	CAS number	50-18-0
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB06859MIG
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	500
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	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	ENDOXAN BAXTER*EV 1FL 1G
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER spA
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.3.4	Pharmaceutical form	Powder for solution for injection
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	CICLOFOSFAMIDE
D.3.9.1	CAS number	50-18-0
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB06859MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

solid tumors metastatic or relapsed, resistant/refractory to conventional therapy

tumori solidi metastatici o recidivati, resistenti/refrattari alle terapie convenzionali

E.1.1.1

Medical condition in easily understood language

Solid tumors with no chances of cure

Tumori solidi senza ulteriore possibilità di cura

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	10006190
E.1.2	Term	Breast cancer invasive NOS
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	25.1
E.1.2	Level	LLT
E.1.2	Classification code	10033612
E.1.2	Term	Pancreatic carcinoma NOS
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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10038415
E.1.2	Term	Renal cell carcinoma stage unspecified
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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10017760
E.1.2	Term	Gastric cancer NOS
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 if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative transplant with peripheral stem cells from HLA-haploidentical donors.

Determinare se l’attecchimento può essere raggiunto in maniera sicura in pazienti affetti da neoplasie ematologiche ad alto rischio che vengano sottoposti a trapianto non mieloablativo con cellule staminali periferiche da donatori HLA-apoloidentici familiari.

E.2.2

Secondary objectives of the trial

Reconstitution of lymphocytes and NK cells

Ricostituzione dei linfociti e delle cellule Natural Killer (NK)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Histologically or cytologically proven diagnosis of renal cell cancer, neurendocrine cancer, pancreatic cancer, rhinopharyngeal lymphoepithelioma, malignant melanoma, soft-tissue sarcoma, ovarian carcinoma, gastric carcinoma, germ cell tumors, breast cancer, colorectal cancer with evidence of unresectable, locally recurrent, or metastatic disease. Locally recurrent disease must not be amenable to resection or radiation therapy with curative intent
- Recurrent/refractory disease after primary treatment and deemed not suitable for standard therapy. Metastatic disease not eligible for standard therapy-potentially curative or able to extend life expectancy.

- Prior treatment with chemotherapy as follows: receipt of adjuvant chemotherapy with RECIST defined disease progression documented during treatment or disease relapse within 6 months of last treatment, or receipt of chemotherapy in the first-line advanced disease setting with RECIST defined disease stable or progression documented during treatment, or, if the patient completed treatment with objective disease response, documented disease stable or progression after discontinuing treatment. Patients entering the study on the basis of this criterion may have also previously received neoadjuvant or adjuvant treatment with chemotherapy.

- Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- Male or female.
- Patients age > 18 and < 70 years.
- ECOG performance status 0-2.
- Resolution of all acute toxic effects of prior therapy or surgical procedures to grade =1 (except alopecia).

- Life expectancy >3 months.
- A fully HLA-identical or alternatively an HLA haploidentical related donor is available.
- The definitions of minimum adequacy for organ function required prior to study entry are as follows:
. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) =2.5 x upper limit of normal (ULN), or AST and ALT =5 x ULN if liver function abnormalities are due to underlying malignancy
. Total serum bilirubin =1.5 x ULN
. Absolute neutrophil count (ANC) =1500/µL
. Platelets =100,000/µL
. Haemoglobin =9.0 g/dL
. Serum creatinine =1.5 x ULN
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

tumori del rene a cellule chiare, tumori neuroendocrini, tumori del pancreas, linfoepiteliomi del rinofaringe, melanomi, sarcomi dei tessuti molli, tumori ovarici, tumori gastrici, tumori a cellule germinali, tumori della mammella, tumori del colon-retto con evidenza di malattia non resecabile, localmente avanzata o metastatica. Il quadro di recidiva locale non deve essere candidabile a chirurgia o radioterapia.
- Malattia recidivata/refrattaria dopo il trattamento di prima linea e ritenuta non candidabile ad una terapia standard. Malattia metastatica non elegibile ad una terapia convenzionale potenzialmente curativa o capace di aumentare l’aspettativa di vita
- Malattia stabile o in progressione, misurabile in accordo ai criteri RECIST.
- Maschi o femmine dai 18 ai 70 anni di età.
- ECOG performance status 0-2.
- Risoluzione di tutti gli effetti collaterali di una precedente terapia o procedura chirurgica ad un grado < 1 (eccetto l’alopecia).
- Aspettativa di vita superiore a 3 mesi.
- Presenza di donatore familiare HLA-identico o Aploidentico
- Presenza di una funzionalità d’organo adeguata, secondo i seguenti criteri:
- Aspartato transaminasi (AST) and alanina transaminasi (ALT) = 2.5X limiti superiori alla norma (UNL) o = 5X ULN se l’anormalità della funzionalità epatica è dovuta al tumore
- Bilirubina serica =1.5X ULN
- Albumina serica =3.0 g/dL
- Conta assoluta dei neutrofili (ANC) =1500/µL
- Piastrine =100,000/µL
- Emoglobina =9.0 g/dL
- Creatinina Serica =1.5 x ULN
- Consenso informato datato e firmato, con paziente che acconsente alle visite previste, ad eseguire i test di laboratorio e tutte le procedure previste dallo studio.

E.4

Principal exclusion criteria

- Uncontrolled CNS involvement with disease
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Females who are pregnant
- Organ dysfunction defined as follows:
¿ Cardiac ejection fraction <30% or uncontrolled cardiac failure
¿ Pulmonary: DLCO <40% predicted
¿ Liver: elevation of bilirubin to > 1.5 x ULN and/or transaminases >5x the upper limit of normal
¿ Renal: Serum creatinine >1.5 x ULN
- ECOG performance status >2
- Patients with poorly controlled hypertension on multiple antihypertensives
- Documented fungal disease that is progressive despite treatment
- Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis
- Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
- Any previous or current malignancy at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix and adequately treated basal or squamous cell carcinoma of the skin.

- Coinvolgimento del sistema nervoso centrale con malattia refrattaria alla terapia intratecale
- Presenza di infezioni attive severe
- Karnofsky score = 60%
- Pazienti con funzionalità cardiaca, epatica o polmonare compromessa ( Frazione di eiezione ventricolare sinistra minore del 35%; Valore di diffusione alveolo-capillare < 40% od ossigenoterapia continua; alterazione della funzionalità epatica , con bilirubina =3 mg/dl e/o transaminasi >4x il limite superiore di normalità; Insufficienza renale con clearance della creatinina <50 cc/min (su urine delle 24 ore)
- Pazienti HIV positivi
- Stato di gravidanza o puerperio
- Pazienti fertili che non sono intenzionati ad utilizzare metodi contraccettivi per i 12 mesi successivi al trattamento
- Aspettativa di vita per ragioni diverse dalla malattia < 3 mesi
- Altre terapie sperimentali concomitanti

E.5 End points

E.5.1

Primary end point(s)

- Donor engraftment at day +84 (efficacy)
- Incidence and severity of GVHD (safety)
- Non-relapse-related mortality at day +200 (safety)

- Valutazione dell’attecchimento al giorno +84
- Incidenza e severità della GVHD
- Mortalità non correlata alla recidiva al giorno +200

E.5.1.1

Timepoint(s) of evaluation of this end point

day +84 for the engraftment and day +200 for non-relapse-related mortality

giorno +84 per l’attecchimento e giorno +200 per la mortalità non dovuta alla recidiva

E.5.2

Secondary end point(s)

Reconstitution of lymphocytes and NK cells

Ricostituzione linfocitaria e delle cellule NK

E.5.2.1

Timepoint(s) of evaluation of this end point

every 2 weeks from transplant for 3 months

ogni 2 settimane per 3 mesi dal trapianto

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

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

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

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

Information not present in EudraCT

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

LPLV

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

Yes

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

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)

During the follow up phase the patient will be followed according to the following schedule:
- every week (Physical examination and hematologic exams) until day 100
- every month (Physical examination and hematologic exams) until one year after treatment
According to clinical indication the patients could be followed more or less frequently.

Durante la fase dei controlli ambulatoriali i pazienti saranno valutati nel modo seguente:
- ogni settimana (visita medica ed esami ematochimici) fino al giorno 100
- ogni mese (visita medica ed esami ematochimici) fino ad un anno dal trapianto
In base alle condizioni cliniche, i pazienti possono essere seguiti più o meno frequentemente

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

2013-06-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-05

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
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:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials