Clinical Trials Register

Summary
EudraCT Number:	2014-001977-15
Sponsor's Protocol Code Number:	KCP-330-009
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:	2015-05-07
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

2014-001977-15

A.3

Full title of the trial

A Phase 2b Open-label, Randomized, Two-arm Study comparing high and low doses of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Studio di fase 2b in aperto, randomizzato, a due bracci mettendo a confronto dosi alte e basse di Selinexor (KPT-330) in pazienti affetti da linfoma diffuso a grandi cellule B (DLBCL) recidivante/refrattario

A.3.1

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

A Phase 2b Open-label, Randomized, Two-arm Study comparing high and low doses of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A.3.2

Name or abbreviated title of the trial where available

SADAL: Selinexor Against Diffuse Aggressive Lymphoma

Selinexor contro il linfoma aggressivo diffuso

A.4.1

Sponsor's protocol code number

KCP-330-009

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02227251

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	Karyopharm Therapeutics, 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	Karyopharm Therapeutics, 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	Leon Research S.L.
B.5.2	Functional name of contact point	Carla D´Altilia
B.5.3	Address:
B.5.3.1	Street Address	Via Enrico Fermi, 3
B.5.3.2	Town/ city	Cordenons (PN)
B.5.3.3	Post code	33084
B.5.3.4	Country	Italy
B.5.4	Telephone number	+393345967636
B.5.5	Fax number	+34987216243
B.5.6	E-mail	cdaltilia@leonresearch.es

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	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1317
D.3 Description of the IMP
D.3.1	Product name	Selinexor 25mg coated tablets
D.3.2	Product code	KPT-330
D.3.4	Pharmaceutical form	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	Selinexor
D.3.9.1	CAS number	1393477-72-9
D.3.9.2	Current sponsor code	KPT-330
D.3.9.4	EV Substance Code	SUB168135
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.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	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1317
D.3 Description of the IMP
D.3.1	Product name	Selinexor 10mg coated tablets
D.3.2	Product code	KPT-330
D.3.4	Pharmaceutical form	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	Selinexor
D.3.9.1	CAS number	1393477-72-9
D.3.9.2	Current sponsor code	KPT-330
D.3.9.4	EV Substance Code	SUB168135
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: 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	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1317
D.3 Description of the IMP
D.3.1	Product name	Selinexor 20mg coated tablets
D.3.2	Product code	KPT-330
D.3.4	Pharmaceutical form	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	Selinexor
D.3.9.1	CAS number	1393477-72-9
D.3.9.2	Current sponsor code	KPT-330
D.3.9.4	EV Substance Code	SUB168135
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	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

Relapsed/Refractory DLBCL

Linfoma diffuso a grandi cellule B (DLBCL) recidivante/refrattario

E.1.1.1

Medical condition in easily understood language

Relapsed/Refractory DLBCL

Linfoma diffuso a grandi cellule B (DLBCL) recidivante/refrattario

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	18.0
E.1.2	Level	HLT
E.1.2	Classification code	10012819
E.1.2	Term	Diffuse large B-cell lymphomas
E.1.2	System Organ Class	100000004851

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 evaluate the efficacy of selinexor 100 mg (High-Sel) and selinexor 60 mg (Low-Sel) in comparison to a minimally effective lower threshold level of overall response rate (ORR) of 20% and to compare ORR between High-Sel and Low-Sel in patients with relapsed/refractory DLBCL.

Valutare l’efficacia di selinexor 100 mg (High-Sel) e selinexor 60 mg (Low-Sel) a confronto con un livello di soglia inferiore minimamente efficace di tasso di risposta obiettiva (ORR) del 20% e confrontare l’ORR tra High-Sel e Low-Sel nei pazienti con DLBCL recidivante/refrattario.

E.2.2

Secondary objectives of the trial

•To determine duration of response (DOR) for each dose level
•To assess the safety profiles of the High-Sel and Low-Sel regimens
•To compare the disease control rate (DCR) of patients with relapsed/ refractory DLBCL, treated with High-Sel versus Low-Sel

•Determinare la durata della risposta (DOR) per ogni livello di dosaggio
•Valutare i profili di sicurezza dei regimi High-Sel e Low-Sel
•Confrontare il tasso di controllo della patologia (DCR)= nei pazienti con DLBCL recidivante/refrattario, trattati con High-Sel vs. Low-Sel

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients, age ≥ 18 years, with pathologically confirmed DLBCL whose disease is relapsed and/or refractory, with documented evidence of disease progression after the most recently administered chemotherapy regimen (according to International Working Group (IWG) criteria for progression of lymphoma, Cheson 2007), and who in the opinion of the investigator are not candidates for high-dose chemotherapy with autologous stem cell rescue, may be considered for enrollment. Patients must have received at least 2 but no more than 4 previous systemic regimens for the treatment of their DLBCL including at least one course of anthracycline-based chemotherapy (unless absolutely contraindicated due to cardiac dysfunction, in which case other active agents such as etoposide, bendamustine or gemcitabine must have been given) and at least one course of anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe toxicity. Patients who were considered ineligible for standard multi-agent immunochemotherapy must have received at least two (and no more than four) prior treatment regimens including at least one course of anti-CD20 antibodies and must be approved by the Medical Monitor. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy. Patients should have an estimated life expectancy of more than 3 months at study entry. DLBCL histology, DLBCL subtype (GCB or non-GCB) as well as DH-DLBCL status will be confirmed/determined in all patients.

L'arruolamento prende in considerazione pazienti, con età ≥ 18 anni, con DLBCL confermato patologicamente la cui malattia è recidivante e/o refrattaria, con prova documentata di progressione della malattia dopo il regime di chemioterapia somministrato più recentemente (secondo i criteri dell'International Working Group (IWG) per la progressione del linfoma, Cheson 2007), che, a giudizio dello sperimentatore, non sono candidati a una chemioterapia ad alto dosaggio con salvataggio autologo di cellule staminali. I pazienti devono aver ricevuto almeno 2 ma non più di 4 precedenti regimi sistemici per il trattamento del loro DLBCL, includendo almeno una sessione di chemioterapia a base di antracicline (a meno che ciò non sia assolutamente controindicato a causa di disfunzione cardiaca; in tal caso devono essere somministrati altri agenti attivi come etoposide, bendamustina o gemcitabina) e almeno una seduta di immunoterapia con anti-CD20 (cioè rituximab), a meno che ciò non sia controindicato a causa di tossicità grave. I pazienti considerati non eleggibili all’immuno-chemioterapia multi-agente standard devono aver ricevuto almeno due (e non più di quattro) regimi di trattamento precedenti, includendo almeno un ciclo di anticorpi anti-CD20 e devono essere approvati dal medico che si occupa del monitoraggio dello studio. Il precedente trapianto di staminali è consentito; induzione, consolidamento, raccolta di cellule staminali, regime di preparazione e trapianto ± mantenimento sono considerati una singola linea di trattamento.
All'inizio dello studio i pazienti non devono avere un'aspettativa di vita stimata superiore ai 3 mesi. L'istologia del DLBLC, il sottotipo di DLBCL (GCB o non GCB) e nonché lo stato DH-DLBCL saranno confermati/determinati in tutti i pazienti.

E.4

Principal exclusion criteria

Patients with histologies other than de novo DLBCL, (i.e., patients with DLBCL transformed from indolent lymphomas, primary mediastinal (thymic) large B-cell lymphoma (PMBL), or active central nervous system (CNS) lymphoma, will be excluded from this study. Patients with CD20 negative DLBCL are also excluded. Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation and documentation for ineligibility must be provided.

I pazienti con istologia diversa rispetto a DLBCL de novo, (ovvero pazienti con DLBCL trasformato da linfomi indolenti, linfoma primitivo a cellule B del mediastino [timico] (PMBL), o linfoma attivo del sistema nervoso centrale (SNC) saranno esclusi da questo studio. Sono anche esclusi i pazienti con DLBCL che presentano CD20 negativa. I pazienti non devono essere eleggibili per una chemioterapia a dosaggio alto con trapianto autologo di cellule staminali e deve essere fornita la documentazione di tale ineleggibilità.

E.5 End points

E.5.1

Primary end point(s)

Objective disease response assessment will be made according to the revised response criteria based on the Guidelines of the IWG reported by Cheson et al. (Cheson 2007). Responses will be adjudicated by an independent review committee, including complete review of all imaging material, laboratory, and clinical data. The data used for primary statistical analysis will be from a central review of the radiological disease assessments.
The primary endpoint is ORR, defined as the proportion of patients who achieve occurrence of either CR or PR according to the revised response criteria based on the Guidelines of the International Working Group (IWG) reported by Cheson et al., and will be assessed as follows:
•ORR to selinexor (High-Sel + Low-Sel) compared to a minimally effective lower threshold level of ORR at 20%.
•ORR to High-Sel compared to Low-Sel

Progression is defined as the first occurrence of progressive disease (PD) per the revised response criteria. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician.

La valutazione della risposta obiettiva alla malattia sarà realizzata secondo i criteri di risposta revisionati sulla base delle Linee Guida dell'IWG riportate da Cheson et al. (Cheson 2007). Le risposte saranno valutate da un comitato di revisione indipendente, includendo la revisione completa di tutti i dati materiali di imaging, di laboratorio e clinici. I dati utilizzati per l'analisi statistica primaria proverranno da una revisione centrale delle valutazioni radiologiche delle patologie.
Il primo end point è L´ORR sarò definito come proporzione di pazienti nei quali si verificano sia CR che PR secondo i criteri di risposta
revisionati sulla base delle Linee Guida dell'IWG riportate da Cheson et al. è sarà valutato come segue:
• ORR per selinexor (High-Sell + Low-Sel), rispetto a un minimo efficace livello di soglia inferiore ORR del 20%.
• ORR per High-Sel rispetto a Low-Sel

La progressione è definita come la prima manifestazione della malattia progressiva (PD) in conformità ai criteri di risposta revisionati. La progressione clinica della malattia in assenza di criteri formali per la PD deve essere documentata da un medico.

E.5.1.1

Timepoint(s) of evaluation of this end point

Disease response will be assessed by the Revised IWG Response Criteria for NHL (Cheson 2007; Appendix 1) in patients on Cycle 3 Day 1 and every 2 months of therapy thereafter until disease progression. There is no maximum treatment duration.

La risposta della malattia sarà valutata dai criteri di risposta modificati IWG per NHL (Cheson 2007; Appendice 1) nei pazienti in ciclo 3 giorno 1 e ogni 2 mesi di terapia in seguito fino a progressione della malattia. Non esiste una durata massima di trattamento

.

E.5.2

Secondary end point(s)

•DOR, defined as the duration of time from first occurrence of CR or PR until the first date that recurrence of disease progression is objectively documented, for each dose level
•Safety endpoints include AE reports, ECOG performance status, vital signs, physical examinations, ECGs, ophthalmic examinations, concomitant medications and laboratory safety evaluations.
•DCR, defined as the proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks following start of therapy, compared for High-Sel and Low-Sel regimens

•La DOR è definita come l’arco di tempo dalla prima manifestazione di CR o PR fino alla prima data in cui la recidiva della progressione della malattia è oggettivamente documentata, per ciascun livello di dose.
•La sicurezza sarà valutata attraverso riscontri di eventi avversi,
performance status [stato di validità] ECOG, esami fisici, elettrocardiogrammi, esami oftalmici, farmaci concomitanti, segni vitali e valutazioni di sicurezza di laboratorio.
•La DCR è definita come la proporzione di pazienti che raggiungono CR, PR o SD per un minimo di 4 settimane dopo l’inizio della terapia, rispetto a High-Sel e regimi bassi-Sel.

E.5.2.1

Timepoint(s) of evaluation of this end point

End of study

Fine dello studio

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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

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

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

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

Austria

Belgium

Canada

France

Germany

Israel

Italy

Spain

United Kingdom

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

LPLV

Ultimo Paziente dell´Ultima Visita (UPUV)

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

104

F.4.2.2

In the whole clinical trial

200

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 a patient has ceased his/her participation in the study, his/her medical doctor will offer the most appropriate treatment currently available.

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

2015-07-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-04

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