Clinical Trials Register

Summary
EudraCT Number:	2006-004504-39
Sponsor's Protocol Code Number:	AIO STO-0601
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-04-24
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

Germany - BfArM

A.2

EudraCT number

2006-004504-39

A.3

Full title of the trial

Multizentrische Phase II-Studie mit Docetaxel, Oxaliplatin und Capecitabin (TEX) bei Patienten mit inoperablem oder metastasiertem Magenkarzinom

A.3.1

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

Docetaxel und Oxaliplatin mit Capecitabin (TEX Regime) bei Patienten mit nicht-operablen oder metastasiertem Magenkrebs

A.3.2

Name or abbreviated title of the trial where available

AIO-TEX

A.4.1

Sponsor's protocol code number

AIO STO-0601

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00511446

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	Martin-Luther-Universität Halle-Wittenberg, vertreten durch den Kanzler
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	Roche Pharma AG
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	Koordinierungszentrum für Klinische Studien
B.5.2	Functional name of contact point	KKS Halle
B.5.3	Address:
B.5.3.1	Street Address	Kiefernweg 34
B.5.3.2	Town/ city	Halle (Saale)
B.5.3.3	Post code	06120
B.5.3.4	Country	Germany
B.5.4	Telephone number	+493455574907
B.5.5	Fax number	+493455575210
B.5.6	E-mail	info@kks-halle.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.2.1.1.1	Trade name	XELODA 500mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Capecitabine
D.3.9.1	CAS number	154361-50-9
D.3.9.2	Current sponsor code	Capecitabin
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	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.2.1.1.1	Trade name	Taxotere 20mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Aventis Pharma S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Docetaxel
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.3.9.1	CAS number	114977-28-5
D.3.9.3	Other descriptive name	DOCETAXEL
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	40
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.2.1.1.1	Trade name	Eloxatin 5 mg/ml Pulver zur Herstellung einer Infusionslösung
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi- Aventis Deutschland GmbH
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.3.1	Product name	Oxaliplatin
D.3.4	Pharmaceutical form	Powder 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	61825943
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.2.1.1.1	Trade name	Taxotere 80mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Aventis Pharma S.A
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Docetaxel
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.3.9.1	CAS number	114977-28-5
D.3.9.3	Other descriptive name	DOCETAXEL
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	40
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.2.1.1.1	Trade name	ELOXATIN 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis Deutschland GmbH
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.3.1	Product name	Oxaliplatin
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	61825943
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.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

Inoperables oder metastasiertem Magenkarzinom

E.1.1.1

Medical condition in easily understood language

Nicht-operabler oder metastasierter Magenkrebs

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	14.0
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

Bestimmung der Wirksamkeit der Kombinationstherapie mit Docetaxel, Oxaliplatin und Capecitabin hinsichtlich des progressionsfreien Überlebens.

E.2.2

Secondary objectives of the trial

Bestimmung Wirkung der Kombinationstherapie mit Docetaxel, Oxaliplatin und Capecitabin hinsichtlich der Zeit bis zur Progression, der Ansprechrate, der Ermöglichung von Resektionen mit potentiell kurativem Ansatz, der Zeit bis zum Therapieversagen, der Dauer des Ansprechens
und des Gesamtüberlebens

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Datierte und unterschriebene Einverständniserklärung des Patienten, einwilligungsfähiger Patient
• Histologisch nachgewiesenes, inoperables, metastasiertes oder rezidiviertes Adenokarzinom des Magens oder des gastroösophagalen Übergangs, d.h.:
• Tx-4 M1 oder T4 M0
• Inoperabilität wird von einem qualifizierten Chirurgen festgelegt; folgende T4 Stadien werden in die Studie aufgenommen:
• (A) T4= mit Infiltration mehrerer Organe.
• (B) T4= mit lokaler Infiltration eines Organs; technisch nicht resektabel.
• (C) T4= mit lokaler Infiltration eines Organs; technisch resektabel; eine erweiterte Magenresektion jedoch aufgrund des Allgemeinzustandes des Patienten, des Alters, aufgrund von Komorbidität oder sonstigen Bedingungen nicht zumutbar.
• Da eine Evaluation des N-Status präoperativ in vielen Fällen nicht möglich ist, wird der N-Status nicht berücksichtigt.
• Eindimensional messbare metastasierte Erkrankung (RECIST) >= 20 mm oder, bei Verwendung von Spiral CT >= 10 mm. Falls es sich um ein Lokalrezidiv handelt, muss zumindest ein messbarer Lymphknoten (mindestens 20 mm im CT) nachweisbar sein.
• ECOG-Status 0,1 oder 2
• Frau oder Mann älter als 18 Jahre
• Lebenserwartung > 3 Monate
• Adäquate hämatologische Funktion:
• Neutrophile Granulozyten >= 1,5 GPT/L
• Thrombozyten >= 100 GPT/L
• Hämoglobin >= 9 g/dl (Transfusion zum Erreichen oder Aufrechterhalten möglich)
• Adäquate Nierenfunktion:
• Kreatinin-Clearance > 50 ml/min (Messung oder indirekte Bestimmung anhand der Cockcroft-Gault-Formel)
• Adäquate Leberfunktion:
• Gesamtbilirubin <= 1,0 x ONW,
• ALAT und ASAT <= 3,5 x ONW
• alkalische Phosphatase < 6 x ONW.
• Ein großer thorax- oder abdominalchirurgischer Eingriff muss mindestens 28 Tage zurückliegen, kleinere chirurgische Eingriffe 14 Tage, die Wunden müssen verheilt sein und der Patient sich davon erholt haben. Eine Portimplantation, eine perkutane endoskopische Gastrostomie und eine diagnostische Laparoskopie können unabhängig vom Chemotherapiebeginn durchgeführt werden.
• Komplettes Staging innerhalb von 28 Tagen vor der ersten Infusion (Thorax-Röntgen oder Thorax-CT, Abdomen-CT, andere falls indiziert)
• Gebärfähige Frauen benötigen einen negativen Schwangerschaftstest innerhalb von 7 Tagen vor Beginn der Chemotherapie, bei postmenopausalen Frauen muss mindestens eine zwölfmonatige Amenorrhöe vorliegen, um als nicht mehr gebärfähig zu gelten.
• Fähigkeit, die Termine einzuhalten und die Toxizitäten zu handhaben

E.4

Principal exclusion criteria

• Jegliche vorherige oder gleichzeitige Chemo-, Immun- und/oder Radiotherapie. Eine perioperative (neoadjuvante oder adjuvante) Chemotherapie muss vor mindestens 6 Monaten abgeschlossen worden sein und im Falle einer adjuvanten Therapie ohne Progress innerhalb von 6 Monaten.
• Zweitmalignom mit Ausnahme eines Basalzellkarzinoms der Haut oder eines kurativ behandelten Carcinoma in situ der Zervix oder anderer kurativ behandelter Tumoren mit einer Rezidivfreiheit von über 5 Jahren
• Symptomatische periphere Neuropathie NCI-CTCAE Grad > 2
• Jegliche Teilnahme an anderen Studien innerhalb der letzten 30 Tage von Studieneinschluss
• Überempfindlichkeit gegen die in der Studie benutzten Medikamente oder deren galenischer Inhaltsstoffe
• Gleichzeitige Behandlung mit Sorivudin oder dessen chemischen Verwandten, wie z.B. Brivudin
• Anamnestisch bekannte, schwerwiegende Erkrankungen oder andere Begleiterkrankungen, die die Teilnahme an dieser Studie beeinträchtigen können, wie z.B.:
• Instabile kardiale Erkrankung: symptomatische Herzinsuffizienz, Angina pectoris, ventrikuläre Herzrhythmusstörungen trotz medikamentöser Behandlung, Myokardinfarkt oder Reanimation innerhalb der letzten 6 Monate vor Studienbeginn
• Aktive Infektion mit der Notwendigkeit für systemische Therapie oder unkontrollierte Infektion
• Interstitielle Lungenerkrankungen (z.B. Pneumonitis oder Lungenfibrose) bzw. Anhalt für interstitielle Lungenerkrakungen im Rö-Thorax oder CT
• Aktive entzündliche Darmerkrankung oder andere Darmerkrankungen, welche chronische Diarrhöe verursachen (definiert als > 4 Stuhlgänge täglich)
• Neurologische oder psychiatrische Erkrankungen unter Einschluss von Demenz, Epilepsie oder unbehandelte, symptomatische ZNS-Metastasen
• Schwangerschaft oder Stillzeit
• Sexuell aktive Männer und (gebärfähige) Frauen mit mangelnder Bereitschaft zur Durchführung suffizienter kontrazeptiver Maßnahmen (Hormonspirale, Depot-Spritze, hormonabgebendes Implantat, Transdermale Kontrazeption, Abstinenz oder Sterilisation des Partners). Eine sichere Kontrazeption muss bis 6 Monate nach der letzten Medikation der Studienmedikation sichergestellt sein.
• Patienten, die die Therapie oder Beobachtungen nicht einhalten können.
• Patienten, die keine Tabletten schlucken können.
• Arzneimittel-, Drogen- oder Alkoholabusus
• Patienten, die nicht in der Lage oder bereit sind, sich protokollgerecht zu verhalten und behandeln sowie nachuntersuchen zu lassen

E.5 End points

E.5.1

Primary end point(s)

Rate des Progressionsfreies Überleben (PFS) nach 6 Monaten

E.5.1.1

Timepoint(s) of evaluation of this end point

Sechs Monate nach Beginn der Kombinationstherapie.

E.5.2

Secondary end point(s)

- Bestimmung der Sicherheit und der Nebenwirkungen und Toxizitäten der Kombinationstherapie mit Docetaxel, Oxaliplatin und Capecitabin
- Erfassung der medianen Zeit bis zur Progression
- Erfassung der objektiven Ansprechrate (CR und PR)
- Erfassung der Rate an Resektionen mit potentiell kurativem Ansatz
- Erfassung der Zeit bis zum Therapieversagen
- Erfassung der Dauer des Ansprechens
- Erfassung des medianen Überlebens

E.5.2.1

Timepoint(s) of evaluation of this end point

Im Rahmen der Tumornachsorge aller 3 Monate bis zum Tod des Patienten bzw. Ausscheiden aus der Studie.

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

Yes

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

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.8.3

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

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

Die Studie ist beendet, wenn alle Patienten aus der Tumornachsorge ausgeschieden sind.

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

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Die Behandlung und Nachsorge der Patienten nach Ausscheiden aus der Studie unterscheidet sich nicht vom üblichen Vorgehen.

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

2007-05-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-06-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-12-20

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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