Clinical Trials Register

Summary
EudraCT Number:	2009-015122-11
Sponsor's Protocol Code Number:	GBG54
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:	2012-01-17
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2009-015122-11

A.3

Full title of the trial

A prospective, randomised multi-centre phase II study evaluating the adjuvant, neoadjuvant or palliative treatment with tamoxifen +/- GnRH analogue versus aromatase inhibitor + GnRH analogue in
male breast cancer patients.

Eine prospektive, randomisierte, multizentrische Phase II Studie zur Evaluierung der Östrogensuppression unter Tamoxifen alleine versus Tamoxifen plus GnRH-Analogon versus Aromatase-Inhibitor plus GnRH-Analogon in der (neo-) adjuvanten und palliativen Therapie männlicher Patienten mit Mammakarzinom.

A.3.2

Name or abbreviated title of the trial where available

GBG 54 - MALE

A.4.1

Sponsor's protocol code number

GBG54

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	GBG Forschungs GmbH
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	Pfizer Pharma GmbH
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	GBG Forschungs GmbH
B.5.2	Functional name of contact point	Dr. Mathias Uhlig
B.5.3	Address:
B.5.3.1	Street Address	Martin-Behaim-Straße 12
B.5.3.2	Town/ city	Neu-Isenburg
B.5.3.3	Post code	63263
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49610274800
B.5.5	Fax number	+4961027480440
B.5.6	E-mail	MALE@GermanBreastGroup.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	Aromasin
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
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	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	Exemestan
D.3.9.1	CAS number	107868-30-4
D.3.9.3	Other descriptive name	EXEMESTANE
D.3.9.4	EV Substance Code	SUB07492MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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	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.3.1	Product name	Goserelin
D.3.4	Pharmaceutical form	Implant
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Implantation
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GOSERELIN ACETATE
D.3.9.4	EV Substance Code	SUB02400MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	10,8
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.3.1	Product name	Leuprorelin
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUPRORELIN ACETATE
D.3.9.1	CAS number	74381-53-6
D.3.9.4	EV Substance Code	SUB02900MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	11.25
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: 4
D.1.2 and D.1.3	IMP Role	Comparator
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.3.1	Product name	Tamoxifen
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	TAMOXIFEN
D.3.9.1	CAS number	10540-29-1
D.3.9.4	EV Substance Code	SUB10825MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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

Breast Cancer in Male Patients

Brustkrebs bei Männern

E.1.1.1

Medical condition in easily understood language

Breast Cancer in Male Patients

Brustkrebs bei Männern

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	19.0
E.1.2	Level	PT
E.1.2	Classification code	10061020
E.1.2	Term	Breast cancer male
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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the estradiol suppression between the three treatment arms after three months.

Vergleich der Östradiolsuppression zwischen den drei Studienarmen nach drei Monaten Therapiedauer.

E.2.2

Secondary objectives of the trial

To determine the estradiol suppression between the three treatment arms after six months
To compare the compliance in the three treatment arms.
To compare the efficacy in terms of overall response (for neoadjuvant and metastatic patients) in the three treatment arms.
To compare testosterone, dihydrotestosterone (DHT), SHBG, FSH, LH, osteocalcin and CTX in the three treatments arms.To determine the safety and side effect parameters (at every visit):
- PSA and hemoglobin.
- Lipids (total cholesterol, high density lipid cholesterol,
low density lipid cholesterol).
- Questionnaires AMS, IIEF, IPSS.
- Adverse events according to NCI-CTCAE version 4.0.
Translational research.

Vergleich der Östradiolsuppression zwischen den drei Studienarmen nach sechs Monaten Therapiedauer.
Vergleich der Compliance zwischen den drei Studienarmen.
Vergleich der Effektivität bezüglich des Ansprechens zwischen den drei Studienarmen für neoadjuvante und metastasierte Patienten.
Vergleich von Testosteron, Dihydrotestosteron, SHBG, LH, FSH, Osteocalcin und CTX in den drei Studienarmen.
Bestimmung von Sicherheitsparametern und Neben-wirkungen (vor Randomisierung, nach drei und sechs Monaten):
- PSA und Hämoglobin.
- Lipidwerte (Gesamtcholesterin, HDL, LDL).
- Fragebögen
Aging Male Symptom Score (AMS),
International Index of Erectil Function (IIEF),
International Prostate Symptom Score (IPSS).
- Unerwünschte Ereignisse nach NCI-CTCAE Version 4.0.
Translationale Forschung

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent for all study procedures.
2. Complete baseline documentation sent to GBG Forschungs GmbH.
3. Male patients.
4. Age ≥ 18 years.
5. Karnofsky-Index ≥ 60 %.
6. Histologically confirmed unilateral or bilateral carcinoma (enrolment possible in neoadjuvant, adjuvant and metastatic situation).
7. no target lesion necessary for metastatic situation
8. Positive hormone receptor status (e.g. ER and/or PR-receptor positive).
9. Completed staging prior randomisation (within 8 weeks after diagnose or last therapy (operation, chemotherapy or radiation): chest X-ray, ultrasound of the liver, bone scan).
In case of positive findings, further investigations are required to verify the findings as clinically indicated.
10. Prior chemotherapy is possible. In case of adjuvant treatment: adequate surgical treatment with histological complete resection including axillary lymph nodes if patients are included as adjuvant treatment. A sentinel lymph node biopsy is possible if the sentinel is not involved.
11. Normal cardiac function must be confirmed by ECG within three months prior to randomisation.
12. Laboratory requirements (≤ 14 days before therapy start):
Hematology
- Hemoglobin ≥ 9 g/dL,
- Leukocytes 4 - 10 x103/µL,
- Thrombocytes 150 - 400 x103/µL.
Hepatic function
- ASAT (SGOT) or ALAT (SGPT) ≤ 2x UNL,
- Total bilirubin ≤ 2x UNL.
Renal function
- Serum creatinine ≤ 1.5x UNL,
- Creatinine clearance > 30mL/min (if creatinine is above UNL, according to Cockroft-Gault).
- Cholesterol 200 - 240 mg/dL (5.18 - 6.22 mmol/L),
- HDL cholesterol > 40 mg/dL (> 1 mmol/L),
- LDL cholesterol ≤ 160 mg/dL (≤ 4 mmol/L).
- Prostate specific antigen (PSA): analysis has to be done
13. Two serum samples (5 mL) centrally made available.
14. Paraffin tumor tissue block and full blood sample centrally made available (except when the patient does not agree to central biomaterial collection).
15. The patient must be accessible for treatment.
Patients can simultaneously be registered in the register study of the University Hospital of Magdeburg.

1. Schriftliche Einwilligungserklärung vor Beginn für alle im Prüfplan beschriebenen Studienprozesse gemäß der lokalen gesetzlichen Bestimmungen.
2. Komplette Baseline-Dokumentation muss an die
GBG Forschungs GmbH gesendet werden.
3. Männlicher Patient.
4. Alter ≥ 18 Jahre.
5. Karnofsky-Index ≥ 60%
6. Histologisch gesichertes, invasives Karzinom der Brust(Studienteilnahme ist in der adjuvaten, neoadjuvanten oder metastasierten Situation möglich)
7. In der metastasierten Situation ist keine Targetläsion erforderlich.
8. Positiver Hormonrezeptor-Status (Östrogen- und/oder Progesteron-Rezeptor positiv).
9. Ein komplettes Staging innerhalb von 8 Wochen nach Diagnose oder letztem Therapieschritt (Operation, Chemotherapie oder Bestrahlung)vor Studienbeginn (Minimum: Röntgen der Lunge, Ultraschall der Leber und Knochenszintigraphie, bei Auffälligkeiten weitere verifizierende Untersuchungen).
10. Vorherige Chemotherapie ist erlaubt. Bei adjuvantem Einschluss des Patienten: adäquate operative Entfernung des Tumors. Die Resektionsränder der endgültigen Operation müssen histologisch frei sein und axilläre Lymphknoten entfernt worden sein. Eine Sentinel Node Biopsie ist erlaubt, falls der Sentinel Node nicht befallen ist.
11. Normale kardiale Funktion bestätigt mittels EKG innerhalb von drei Monaten vor Randomisierung.
12. Laboruntersuchungen (≤ 14 Tage vor Therapiestart):
Hämatologie
- Hämoglobin ≥ 9 g/dl,
- Leukozyten 4 - 10 x103/µl,
- Thrombozyten 150 - 400 x103/µl.
Leberfunktion
- ASAT (SGOT) oder ALAT (SGPT) ≤ 2x UNL,
- Gesamt-Bilirubin ≤ 2x UNL.
Nierenfunktion
- Serum-Kreatinin ≤ 1.5x UNL,
- Kreatinin-Clearance > 30ml/min (falls Kreatinin > UNL,
nach Cockroft-Gault).
- Cholesterol 200 - 240 mg/dl (5.18 - 6.22 mmol/l),
- HDL-Cholesterol > 40 mg/dl (> 1 mmol/l),
- LDL-Cholesterol ≤ 160 mg/dl (≤ 4 mmol/l).
- Prostata-spezifisches Antigen (PSA): Analyse verpflichtend
13. Zwei Serumproben (5 ml) an Zentrallabor gesendet.
14. FFPE-Block und Vollblutprobe an Zentrallabor gesendet (außer Patient hat der Biomaterialsammlung nicht zugestimmt).
15. Patient muss für den Zeitraum der Behandlung zur Verfügung stehen.
Die gleichzeitige Teilnahme an der Registerstudie zum Mammakarzinom des Mannes des Universitätsklinikums Magdeburg ist möglich.

E.4

Principal exclusion criteria

1. Female patients.
2. Prior endocrine therapy of breast carcinoma.
3. Known or suspected hypersensitivity reaction to the compounds or incorporated substances.
4. No indication for endocrine treatment.
5. Life expectancy of less than six months.
6. International Prostate Symptom Score (IPSS) > 17.
7. Prostate carcinoma
8. History of prostate cancer within the last five years and regardless the time frame all patients with hormone receptor positive prostate carcinoma who have received endocrine treatment.
9. Concurrent neuronal or cardiac disease, poorly controlled arterial hypertension.
10. Previous thromboembolic event within the last five years (except for thromboembolic events correlated to implanted devices (e.g. port thrombosis)).
11. Currently active hepatitis.
12. Disease significantly affecting gastrointestinal function, e.g. malabsorption syndrome, resection of the stomach or small bowel.
13. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
14. Patients who are not able to give informed consent as defined according to AMG.

1. Weibliche Patienten.
2. Vorherige antihormonelle Therapie zur Behandlung des Mammakarzinoms.
3. Bekannte oder vermutete Hypersensitivität gegen die Prüf-substanzen oder gegen einen der Begleitstoffe.
4. Keine Indikation für endokrine Therapie.
5. Lebenserwartung unter sechs Monaten.
6. International Prostate Symptom Score (IPSS) > 17.
7. Prostatakarzinom
8. Prostatakarzinom innerhalb der letzten fünf Jahre oder – unabhängig vom Zeitfenster – Z.n. endokriner Behandlung eines Prostatakarzinoms.
9. Signifikante neuronale oder kardiale Erkrankungen, schlecht oder unkontrollierter Bluthochdruck.
10. Thromboembolische Ereignisse in den letzten fünf Jahren (ausgenommen Portthrombosen).
11. Aktive Hepatitis.
12. Signifikante gastrointestinale Erkrankungen, wie z.B. Malabsorbtionssyndrom, Resektion des Magens oder Dünndarms
13. Zeitgleiche Behandlung mit anderen experimentellen Substanzen oder einer anderen Krebstherapie oder Teilnahme an einer anderen klinischen Prüfung mit nicht zugelassener Prüfsubstanz innerhalb 30 Tage vor Randomisierung.
14. Patienten, denen es nicht möglich ist eine Ein¬ver¬ständnis-erklärung abzugeben.

E.5 End points

E.5.1

Primary end point(s)

Estradiol suppression between the three treatment arms after three months.

Östradiolsuppression zwischen den drei Studienarmen nach drei Monaten Therapiedauer.

E.5.1.1

Timepoint(s) of evaluation of this end point

After three months of study treatment.

Nach drei Monaten Studienmedikation.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

After six months of study treatment.

Nach sechs Monaten Studienmedikation.

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

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

The regular end of study is defined as 4 weeks after the last patient completed (or discontinued) the study medication.

Das Studienende ist vier Wochen nach dem der letzte Patient die letzte Medikation eingenommen hat.

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.2 Gender

F.2.1

Female

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

F.3.3.1

Women of childbearing potential not using contraception

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.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)

As no study specific treatment or investigation is planned after the end of systemic treatment, surgery and follow up are not part of this study. However, information on the health status of the patients might be collected either based on yearly chart reviews at the sites or based on information deriving from the GBG registry of previous study participants.

Da keine studienspezifische Behandlung oder Untersuchung nach Ende der systemischen Studientherapie geplant ist, sind Operation und Follow-up-Phase kein Teil dieser Studie. Allerdings werden Informationen über den Gesundheits-zustand der Patienten entweder anhand der jährlichen Krankenaktenauswertung an den Zentren oder mittels des GBG-Selbstauskunftsregisters eingeholt.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-07-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-08-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-06-12

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