Clinical Trials Register

Summary
EudraCT Number:	2013-002023-41
Sponsor's Protocol Code Number:	CRC1
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-08-30
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

Netherlands - Competent Authority

A.2

EudraCT number

2013-002023-41

A.3

Full title of the trial

Image guided treatment optimalization with cetuximab for patients with metastatic colorectal cancer: IMPACT - CRC

Optimalisatie van de behandeling van uitgezaaide dikke darmkanker met cetuximab middels PET imaging.

A.3.1

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

Image guided treatment optimalization with cetuximab for patients with metastatic colorectal cancer: IMPACT - CRC

Optimalisatie van de behandeling van uitgezaaide dikke darmkanker met cetuximab middels PET imaging.

A.4.1

Sponsor's protocol code number

CRC1

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	VU University Medical Center
B.1.3.4	Country	Netherlands
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	KWF-Alpe d’Huzes
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	VU University Medical center
B.5.2	Functional name of contact point	Trial Office
B.5.3	Address:
B.5.3.1	Street Address	de Boelelaan 1117
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1081 HV
B.5.3.4	Country	Netherlands
B.5.6	E-mail	trialoffice-onc@vumc.nl

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	Erbitux
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck KGaA
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	cetuximab
D.3.2	Product code	L01XC06
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.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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)	Yes
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	cetuximab-N-SUCDF-89ZR
D.3.2	Product code	89ZR-cetuximab
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	CETUXIMAB
D.3.9.1	CAS number	205923-56-4
D.3.9.4	EV Substance Code	SUB01178MIG
D.3.10	Strength
D.3.10.1	Concentration unit	MBq megabecquerel(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	37
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
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	Vectibix
D.2.1.1.2	Name of the Marketing Authorisation holder	Amgen BV
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	panitumumab
D.3.2	Product code	L01XC08
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.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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)	Yes
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

metastatic colorectal cancer

uitgezaaide dikke darmkanker

E.1.1.1

Medical condition in easily understood language

metastatic colorectal cancer

uitgezaaide dikke darmkanker

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10052362
E.1.2	Term	Metastatic colorectal cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

PART I:
1) to demonstrate 89Zr-cetuximab uptake in non-hepatic tumor lesions at standard dose or at cohort wise increased cetuximab doses (dose escalation). 2) to determine the association between 89Zr-cetuximab uptake in non-hepatic tumor lesions and treatment response.
3) to determine the association between metabolic change (evaluated with 18F-FDG PET after 2 weeks of treatment) and treatment response.

PART II
1)Validate early response evaluation with 18F-FDG PET and the association with treatment benefit.
2) Evaluate optimal quantification methods for 18F-FDG PET images

Deel I:
1) 89Zr-cetuximab opname aantonen in niet-hepatogene tumor laesies bij standard dosering of per cohort opgehoogde dosering cetuximab doses (dose escalatie).
2) de associatie bepalen tussen 89Zr-cetuximab opname in niet-hepatogene tumor laesies en respons op de behandeling.
3) De correlatie tussen veranderingen in metabole activiteit van een tumor laesie (bepaald met 18F-FDG PET) na 2 weken behandeling en response op de behandeling bepalen.

Deel II:
1) Valideren van de vroege response evaluatie met 18F-FDG PET en de correlatie met behandel voordeel (volgens RECIST v1.1.).
2) Evalueren wat de optimale quantificatie methode van deze PET scans is (aantal laesies en welke semi-quantitatieve unit).

E.2.2

Secondary objectives of the trial

- association between levels of uptake of 89Zr-cetuximab in the liver vs. levels of uptake in non-hepatic tumor lesions
-pharmacokinetics of 89Zr-cetuximab and cetuximab
-Can the response observed on [18F]-FDG-PET serve as an early response marker for future response to targeted therapy according to RECIST1.1?
-Explore tumor perfusion with 15O-H2O in a subgroup of patients. These data will serve to explain whether and how 89Zr-cetuximab uptake is a function of tumor perfusion.
-association between 89Zr-cetuximab uptake in tumor lesions, grade of skin toxicity, serum magnesium concentration abnormalities and response according to RECIST1.1?
-Relation of tumor and serum microRNA (miRNA) profiles and response to therapy?
-Study tumor (phospho)proteomic and serum peptide profiles in relation to response to therapy.
-Study germline and tumor DNA mutation profiles in relation to response to therapy.
-Study circulating tumors cells (CTCs) in relation to response to therapy.

-Correlatie tussen 89Zr-cetuximab opname in de lever en opname in andere tumor laesies (geen lever)
-Farmacokinetiek van 89Zr cetuximab en cetuximab
-Bestuderen of de uitkomst bepaald d.m.v. [18F]-FDG-PET kan fungeren als een vroege voorspeller voor uitkomst op therapie volgens RECIST1.1
-Bestuderen van tumor perfusie met 15O- H2O in een patiënten subgroep. Om te verklaren of en hoe 89Zr-cetuximab opname een functie is van tumor perfusie.
-Bepalen of er een correlatie is tussen 89Zr-cetuximab tumoropname, mate van huidtoxiciteit, serum magnesium concentratie afwijkingen en uitkomst op therapie volgens RECIST1.1
-Bestuderen of er een relatie is tussen tumor en serum microRNA profielen en uitkomst op therapie
-Relatie tussen fosfo(protemoics) en serum peptide profielen en uitkomst op therapie?
-Relatie tussen kiembaan en tumor DNA mutatie profielen en uitkomst op therapie
-Relatie tussen tumor cellen die in het bloed gevonden kunnen worden en uitkomst op therapie

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Advanced colorectal adenocarcinoma
• Subjects must have been treated according to standard care with a fluoropyrimidine (e.g. fluorouracil or capecitabine), irinotecan, and oxaliplatin or had contra-indications to treatment with these drugs.
• Age ≥ 18 years.
• Histological or cytological documentation of cancer is required.
• Tumor material must be tested wild type for the K-RAS and B-RAF gene.
• Tumor lesion:
o Part I: Subjects have at least one measurable lesion ≥ 2 cm outside the liver. Lesions must be evaluable by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
o Part II: Subjects have at least one measurable tumor lesion ≥ 1 cm, including liver tumor lesion. Lesions must be evaluable by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• ECOG Performance Status of 0, 1 or 2
• Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
o Total bilirubin ≤ 1.5 times the upper limit of normal
o ALT and AST ≤ 2.5 times upper limit of normal (≤ 5 times upper limit of normal for subjects with liver involvement of their cancer)
o Serum creatinin ≤ 1.5 times upper limit of normal or a calculated creatinin clearance ≥ 50 ml/min
• Signed informed consent must be obtained prior to any study specific procedures.

• uitgezaaide dikke darmkanker.
• patiënten die al standaardtherapie hebben gehad met een fluoropyrimidine (bijv. fluorouracil or capecitabine), irinotecan, and oxaliplatin of deze middelen niet meer verdragen.
• leeftijd ≥ 18 jaar
• Histologische of cytologische verslagen van de tumor zijn aanwezig
• Tumor moet getest zijn op wild type van het K-RAS en B-RAF gen
• Tumor laesie:
o Deel 1: patiënten hebben tenminste 1 meetbare laesie ≥ 2 cm buiten de lever. Laesies moeten meetbaar zijn met een CT of MRI volgens Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Deel 2: patiënten hebben tenminste 1 meetbare laesie ≥ 1 cm. Laesies moeten meetbaar zijn met een CT of MRI volgens Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
• WHO-score van 0, 1 of 2
• Goede lever en nier functies; de volgende labwaarden moeten bepaald worden niet langer dan 7 dagen voor screenen
o Totale bilirubine ≤ 1.5 keer de normale waarde
o ALT and AST ≤ 2.5 keer de normale waarde (≤ 5 keer de normale waarde voor patiënten met leverkanker)
o Serum creatinine ≤ 1.5 keer de normale waarde of een berekende creatinine klaring ≥ 50 ml/min
• Patienteninformatie moet getekend worden alvorens het onderzoek begint.

E.4

Principal exclusion criteria

• Previous exposure to an anti-EGFR therapy
• Significant skin condition interfering with treatment
• Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug.
• Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug.
• Radiotherapy to the target lesions during study or within 4 weeks of the start of study drug. Palliative radiotherapy will be allowed.
• Major surgery within 28 days of start of study drug.
• Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
• Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

• Eerdere behandeling met een anti-EGFR middel
• Slechte huidconditie die met de behandeling interfereert.
• zwangere vrouwen of vrouwen die borstvoeding geven. Vruchtbare vrouwen moeten een negatieve zwangerschapstest hebben. Deze moet binnen 7 dagen voor start van de behandeling uitgevoerd worden. Zowel mannen als vrouwen moeten anticonceptie gebruiken gedurende de studie (zoals een pessarium, condoom). Orale anticonceptie wordt niet beschouwd als geschikte anticonceptie, omdat het met de farmacokinetiek van de studiemedicatie kan interfereren. Het gebruik van orale en niet-orale anticonceptie strekt tot aanbeveling. Het gebruik van anticonceptie is 6 maanden na het onvangen van de laatste dosis van de studiemedicatie noodzakelijk.
• Gelijktijdige toediening van chemotherapie, immunotherapie, of een ander antikankermiddel tijdens de studie of 4 weken voor start van de studie.
• Radiotherapie van de target laesies tijdens de studie of 4 weken voor start van de studie. Pallitatieve radiotherapie is wel toegestaan.
• Een ingrijpende operatie 28 dagen voor start studie
• Drugsmisbruik, medische, psychologische of sociale condities die kunnen interfereren met deelname aan de studie of evaluatie van de studie resultaten.
• Elke conditie die niet stabiel is voor de proefpersoon of de proefpersoon in gevaar kan brengen en/of haar/zijn deelname aan de studie kan belemmeren.

E.5 End points

E.5.1

Primary end point(s)

Part 1A:
89Zr-cetuximab uptake in non-hepatic metastases (corrected VOIs);
Clinical benefit rate (CBR).

Part 1B:
89Zr-cetuximab uptake in non-hepatic metastases with increased dosing of cetuximab (corrected VOIs).

Part 2:
Association between CBR and early response evaluation using 18F-FDG PET. CBR is defined as the sum of CR, PR and SD according to RECIST 1.1 at 3 months after treatment start. Corrected VOIs are defined as measurements in VOI corrected for background levels.

Deel1A:
89Zr-cetuximab opname in de metastase (geen lever)
Mate van klinische effectiviteit.

Deel 1B:
89Zr-cetuximab opname in de metastasen (geen lever) bij oplopende dosering van cetuximab.

Deel 2:
klinische baten van cetuximab (standaard dosering) en de correlatie met de uitkomsten van de vroege evaluatie met 18F-FDG PET.

E.5.1.1

Timepoint(s) of evaluation of this end point

4 - 6 years after study commences

4 - 6 jaar na start studie

E.5.2

Secondary end point(s)

1) The % uptake (of total injected) 89Zr-cetuximab in non-tumor liver tissue and hepatic metastases (corrected VOIs).
2) 18F FDG-PET uptake before and after 2 weeks of cetuximab treatment.
3) Grade of skin toxicity as measured by predefined criteria.

1) percentage opname (van totaal geinjecteerde) 89Zr-cetuximab in de niet lever metastasen en metastase in de lever.
2) 18F FDG-PET opname voor en na 2 weken cetuximab behandeling.
3) Mate van huid toxiciteit

E.5.2.1

Timepoint(s) of evaluation of this end point

4 - 6 years after study commences
1 year follow-up and data analysis

4 - 6 jaar na start studie
1 jaar follow-up en data analyse

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

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

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

Yes

E.8.1.7.1

Other trial design description

interventie

intervention

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

The study has a two stage design. If in the first stage, 10 patients do not show uptake of 89Zr cetuximab in a non-hepatic tumour lesion, the study will be halted.

De studie bestaat uit 2 delen. Indien er in het eerste deel van de studie geen 89Zr cetuximab opname in tumor laesies buiten de lever wordt geobserveerd in de eerste 10 patienten, wordt de studie beeindigd.

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

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

151

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)

When available, 4th line treatment, regorafenib, is an option for these patient

Een 4e lijns behandeling is nog mogelijk voor deze patienten, namelijk regorafenib, wanneer deze beschikbaar is.

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

2013-08-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-28

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-01-07

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