Clinical Trials Register

Summary
EudraCT Number:	2009-014895-23
Sponsor's Protocol Code Number:	#0038
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-01-17
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2009-014895-23

A.3

Full title of the trial

Phase II clinical trial of a sequential therapy involving the FLOT regiment in palliative first-line treatment followed by AIO plus irinotecan in second-line treatment combined with supportive parenteral nutrition and physical activity in patients with advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction - impact on quality of life and fatigue: FLOTIRI - gastric cancer trial

Phase II-Studie einer Therapiesequenz mit dem FLOT-Regime in der palliativen Erstbehandlung gefolgt von AIO plus Irinotecan in der Zweitbehandlung zusammen mit supportiv-parenteraler Ernährung und Bewegungstherapie bei Patienten mit fortgeschrittenem inoperablem Adenokarzinom des Magens und des gastroösophagealen Überganges –
Einfluss auf Lebensqualität und Fatigue:
FLOTIRI – Magenkarzinom-Studie

A.3.1

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

Phase II clinical trial of palliativ treatment of patients with advanced non-operable gastric carcinoma: FLOT regimen followed by AIO regimen and irinotecan combined with artificial nutrition and physical activity - impact on quality of life and fatigue: FLOTIRI gastric cancer trial

Klinische Prüfung der Phase II der palliativen Therapie von Patienten mit fortgeschrittenem inoperablem Magenkarzinom: FLOT-Regime gefolgt von AIO-Regime mit Irinotecan zusammen mit künstlicher Ernährung und Bewegungstherapie - Einfluss auf Lebensqualität und Müdigkeit: FLOTIRI Magenkarzinom-Studie

A.3.2

Name or abbreviated title of the trial where available

FLOTIRI

A.4.1

Sponsor's protocol code number

#0038

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	Universitätsklinikum Erlangen
B.1.3.4	Country	Germany
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	medac Gesellschaft für klinische Spezialpräparate mbH
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Fresenius Kabi Deutschland GmbH
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Stiftung Leben mit Krebs
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinikum Erlangen
B.5.2	Functional name of contact point	Medizinische Klinik 1
B.5.3	Address:
B.5.3.1	Street Address	Ulmenweg 18
B.5.3.2	Town/ city	Erlangen
B.5.3.3	Post code	91054
B.5.3.4	Country	Germany
B.5.4	Telephone number	004991318535060
B.5.5	Fax number	004991318535062
B.5.6	E-mail	axel.wein@uk-erlangen.de

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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	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	5-FLOUROURACIL
D.3.9.3	Other descriptive name	5-FLOUROURACIL
D.3.9.4	EV Substance Code	SUB27520
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	50
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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	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	FOLIC ACID
D.3.9.1	CAS number	59-30-3
D.3.9.4	EV Substance Code	SUB07774MIG
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	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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Concentrate for 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	OXALIPLATIN
D.3.9.1	CAS number	61825-94-3
D.3.9.4	EV Substance Code	SUB09490MIG
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	5
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: 4
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.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Concentrate for 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	IRINOTECAN
D.3.9.1	CAS number	97682-44-5
D.3.9.4	EV Substance Code	SUB08295MIG
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	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: 5
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.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Concentrate for 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	DOCETAXEL
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
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	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

Advanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junction

Fortgeschrittenes inoperables Adenokarzinom des Magens und des gastroösophagealen Übergangs

E.1.1.1

Medical condition in easily understood language

Advanced non-operable stomach cancer

Fortgeschrittener inoperabler Magenkrebs

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.1
E.1.2	Level	PT
E.1.2	Classification code	10017758
E.1.2	Term	Gastric cancer
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

Median survival

Mediane Überlebenszeit

E.2.2

Secondary objectives of the trial

• Response rate to first and second line treatment („best response“; CR, PR)
• Grade of histologically assessed remission (primary tumour and distant metastases) according to Becker criteria
• One- and 2-year survival rate
• Percentage of patients with stable disease (SD)
• Time to progression (TTP) of first and second-line treatment
• NCI-CTC toxicity of first and second-line treatment
• Assessment of quality of life (EORTC-QLQ-C15-PAL) and fatigue (MFI) during palliative first and second-line treatment
• Impact of supportive parenteral nutrition and physical activity on quality of life and fatigue during palliative first and second-line treatment
• Percentage of secondary curative resection of metastases (after downsizing by palliative first-line treatment

• Bestimmung der Ansprechrate der Erst- und Zweitbe-handlung („best response“; CR, PR)
• Histologischer Remissionsgrad im Resektionspräparat (Primärtumor und Fernmetastasen) nach Becker-Kriterien
• Ein- und Zweijahresüberlebensrate
• Anteil der Patienten mit Stabilisierung der Erkrankung (SD)
• Zeit bis zur Tumorprogression (TTP) der Erst- und der Zweitbehandlung
• Erfassung der Toxizität (NCI-CTC) der Erst- und Zweitbehandlung
• Erfassung der Lebensqualität (EORTC-QLQ-C15-PAL) und Fatigue (MFI) während der palliativen Erst- und Zweitbehandlung
• Einfluss der supportiven parenteralen Ernährung und der Bewegungstherapie auf Lebensqualität und Fatigue während der palliativen Erst- und Zweitbehandlung
• Rate der sekundären kurativen Metastasenresektion (nach Downsizing durch die palliative Erstbehandlung

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Histologically proven advanced adenocarcinoma of the stomach or the gastro-oesophageal junction with distant metastases including lymph node metastasis, e.g. supraclavicular or para-aortal (M1 [HEP, PUL, LYM] (UICC stage IV)
• Age: ≥ 18 und ≤ 75 years
• Life expectancy: minimum 3 months
• ECOG index 0-2
• Sufficient bone marrow function defined as leucozytes  3.500/µl, thrombocytes  100.000/µl
• Sufficient renal function defined as serum creatinine  2,0 mg/dl or creatinin clearance > 30 ml/min.
• Sufficient hepatic function defined as serum bilirubine  2,0 mg/dl, exception: orbus Gilbert-Meulengracht
• Signed informed consent

• Histologisch nachgewiesenes fortgeschrittenes Adenokarzinom des Magens und des gastroösophagealen Überganges mit Fernmetastasen, auch Lymphknotenmetastasen, z.B. supraclaviculär oder para-aortal (M1 [HEP, PUL, LYM] (UICC-Stadium IV)
• Alter: ≥ 18 und ≤ 75 Jahren
• Lebenserwartung: mindestens drei Monate
• ECOG – Index 0-2
• Ausreichende Knochenmarksreserve definiert als Leukozyten  3.500/µl, Thrombozyten  100.000/µl
• Ausreichende Nierenfunktion definiert als Serumkreatinin  2,0 mg/dl oder Kreatininclearance > 30 ml/min.
• Ausreichende Leberfunktion definiert als Serumbilirubin  2,0 mg/dl, Ausnahme: Morbus Gilbert-Meulengracht
• Schriftliches Einverständnis des Patienten nach Aufklärung

E.4

Principal exclusion criteria

• Hypersensibility to 5-FU, sodium folinate, irinotecan, docetaxel oder oxaliplatin
• Previous systemic chemotherapy
• Severe concomitant diseases which preclude therapy
• Bone marrow suppression
• Chronic diarrhoea (> NCI – CTC - grade 1)
• Chronic inflammatory intestinal diseases or subtotal intestinal obstruction
• Concomitant therapy with other anticancer drugs
• Treatment with allopurinol and trimethroprim
• Pregnancy and lactation
• No adequate contrazeption for pre-menopausal females
• Participation in clinical trials with non-approved drugs

• Überempfindlichkeit gegenüber 5-FU, Natriumfolinat, Irinotecan, Docetaxel oder Oxaliplatin
• Vorherige systemische Chemotherapie
• Schwerwiegende internistische Begleiterkrankungen, die eine Therapie ausschließen
• Knochenmarksinsuffizienz
• Chronische Diarrhoe (> NCI – CTC - Grad 1)
• Chronisch entzündliche Darmerkrankungen oder subtotale Darmobstruktion
• Begleittherapie mit anderen antineoplastischen Substanzen
• Therapie mit Allopurinol und Trimethroprim
• Gravidität und Laktation
• Keine adäquate Kontrazeption für prämenopausale Frauen
• Teilnahme an Studien mit nicht zugelassenen Medikamenten

E.5 End points

E.5.1

Primary end point(s)

Median survival

Mediane Überlebenszeit

E.5.1.1

Timepoint(s) of evaluation of this end point

Last visit last subject

Letzte Visite des letzten Studienteilnehmers

E.5.2

Secondary end point(s)

Response rate to first and second line treatment („best response“; CR, PR)
• Grade of histologically assessed remission (primary tumour and distant metastases) according to Becker criteria
• One- and 2-year survival rate
• Percentage of patients with stable disease (SD)
• Time to progression (TTP) of first and second-line treatment
• NCI-CTC toxicity of first and second-line treatment
• Assessment of quality of life (EORTC-QLQ-C15-PAL) and fatigue (MFI) during palliative first and second-line treatment
• Impact of supportive parenteral nutrition and physical activity on quality of life and fatigue during palliative first and second-line treatment
• Percentage of secondary curative resection of metastases (after downsizing by palliative first-line treatment

Bestimmung der Ansprechrate der Erst- und Zweitbe-handlung („best response“; CR, PR)
• Histologischer Remissionsgrad im Resektionspräparat (Primärtumor und Fernmetastasen) nach Becker-Kriterien
• Ein- und Zweijahresüberlebensrate
• Anteil der Patienten mit Stabilisierung der Erkrankung (SD)
• Zeit bis zur Tumorprogression (TTP) der Erst- und der Zweitbehandlung
• Erfassung der Toxizität (NCI-CTC) der Erst- und Zweitbehandlung
• Erfassung der Lebensqualität (EORTC-QLQ-C15-PAL) und Fatigue (MFI) während der palliativen Erst- und Zweitbehandlung
• Einfluss der supportiven parenteralen Ernährung und der Bewegungstherapie auf Lebensqualität und Fatigue während der palliativen Erst- und Zweitbehandlung
• Rate der sekundären kurativen Metastasenresektion (nach Downsizing durch die palliative Erstbehandlung

E.5.2.1

Timepoint(s) of evaluation of this end point

Last visit last subject

Letzte Visite des letzten Studienteilnehmers

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

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

Letzte Visite des letzten Studienteilnehmers

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Patients with incurable disease

Patienten mit unheilbarer Erkrankung

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

None

Keine

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

2013-02-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-07-22

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-04-30

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IMP with orphan designation in the indication
Orphan Designation Number:
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