Clinical Trials Register

Summary
EudraCT Number:	2010-022646-24
Sponsor's Protocol Code Number:	AB10005
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Prohibited by CA
Date on which this record was first entered in the EudraCT database:	2015-04-28
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2010-022646-24

A.3

Full title of the trial

A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate efficacy and safety of masitinib in combination with gemcitabine or carboplatin or capecitabine in patients with a metastatic or locally advanced breast cancer (all hormonal status tumor except triple negative tumor) and who relapsed after a first line chemotherapy

Prospektívna, multicentrická, otvorená, randomizovaná, nekontrolovaná, štúdia fázy 1/2 na zhodnotenie účinnosti a bezpečnosti masitinibu v kombinácii s gemcitabínom alebo karboplatinou alebo kapecitabínom u pacientok s metastatickou alebo lokálne pokročilou rakovinou prsníka (všetky hormonálne statusy okrem trojito negatívneho nádoru), a ktoré relapsovali po prvej línii chemoterapie.

A.3.1

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

Evaluation of masitinib combined to gemcitabine, carboplatin or capecitabine in patients with a metastatic or locally advanced breast cancer relapsing after a first chemotherapy treatment

Zhodnotenie masitinibu v kombinácii s gemcitabínom, karboplatinou alebo kapecitabínom u pacientok s metastatickou alebo lokálne pokročilou rakovinou prsníka po prvej liečbe chemoterapiou

A.4.1

Sponsor's protocol code number

AB10005

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	AB Science
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AB Science
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AB Science
B.5.2	Functional name of contact point	Alain Moussy
B.5.3	Address:
B.5.3.1	Street Address	3 avenue George V
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75008
B.5.3.4	Country	France
B.5.4	Telephone number	0637402308
B.5.5	Fax number	0147202411
B.5.6	E-mail	alain.moussy@ab-science.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	masitinib
D.3.2	Product code	AB1010
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	masitinib mesylate
D.3.9.1	CAS number	790-299-79-5
D.3.9.2	Current sponsor code	AB1010
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	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	masitinib mesylate
D.3.9.1	CAS number	790-299-79-5
D.3.9.2	Current sponsor code	AB1010
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	200
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	Carboplatin/Paraplatin
D.2.1.1.2	Name of the Marketing Authorisation holder	Aguettant, Sanofi Aventis/Sandoz/Qualimed/Merck/Teva/Faulding/Bristol/Myers Squibb
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Carboplatine
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	Carboplatine
D.3.9.1	CAS number	41575-94
D.3.9.2	Current sponsor code	255-446-0
D.3.9.3	Other descriptive name	not applicable
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
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

Metastatic or locally advanced breast cancer

Metastatická alebo lokálne pokročilá rakovina prsníka

E.1.1.1

Medical condition in easily understood language

breast cancer

rakovina prsníka

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast 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

Overall Survival (OS)

Celkové prežitie (OS)

E.2.2

Secondary objectives of the trial

o Survival rate every 6 weeks until week 24 and every 12 weeks thereafter
• Tumour assessment:
o Overall Progression Free Survival (PFS)
o PFS rate every 6 weeks until week 24 and every 12 weeks thereafter
o Overall Time to progression (TTP)
o TTP rate every 4 weeks
o Objective response rate (CR + PR) every 6 weeks until week 24 and every 12 weeks thereafter
o Control disease rate (CR + PR + SD) at week every 6 weeks until week 24 and every 12 weeks thereafter
o Best response during study treatment
• Level of serum CA 15-3 every 6 weeks until week 24 and every 12 weeks thereafter.
• Quality of life assessment according to the EORTC QLQ-C30 questionnaire every 6 weeks until week 24 and every 12 weeks after
• ECOG Performance Status every 6 weeks until week 24 and every 12 weeks after
• Safety profile using the NCI CTC v4.02 classification
• Pharmacokinetics
• CDA activity and pharmacogenomic analysis.

• Miera prežitia každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
• Hodnotenie nádoru:
o Celková miera prežitia bez progresie ochorenia (PFS)
o Miera PFS každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
o Miera TTP každé 4 týždne
o Objektívna miera odozvy (CR + PR) každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
o Kontrola ochorenia (CR + PR + SD) každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
o Najlepšia odozva počas liečby
• Hladina séra CA 15-3 každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
• Hodnotenie kvality života podľa dotazníku EORTC QLQ-C30 každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
• ECOG status výkonnosti každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
• Bezpečnostný profil pomocou klasifikácie NCI CTC v4.02
• Farmakokinetika
• Analýza fenotypov vybraných génov

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient with histologically or cytologically confirmed metastatic or locally advanced breast cancer
2. Patient with Hormone Receptor (ER and PR) – positive and/or negative and/or unknown status; HER2-positive and/or negative and/or unknown status (patients who have both unknown or negative HR and HER2 status, are not eligible for the study)
3. At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
4. Patient with progression after a first line of treatment in locally advanced/metastatic setting (a line of treatment is defined as at least one normal cycle of chemotherapy) with antracycline and/or taxane (or trastuzumab-based if HER2+)
5. Patient eligible for receiving a second line chemotherapy including gemcitabine, carboplatin and capecitabine.
6. ECOG Performance status ≤2
7. Patient with adequate organ function:
• Absolute Neutrophils Count (ANC) ≥1.5 x 109/L
• Haemoglobin ≥10 g/dL
• Platelets (PTL) ≥ 75 x 109/L
• AST/ALT ≤3 x ULN (≤5 x ULN in case of liver metastases)
• Gamma-GT ≤ 2.5 x ULN (≤5 x ULN in case of liver metastases)
• Bilirubin ≤1.5 x ULN (≤3x ULN in case of liver metastases)
• Normal creatinine or if abnormal creatinine, creatinin clearance ≥50 mL/min (Cockcroft and Gault formula)
• Albumin >1 xLLN
• Proteinuria < 30 mg/dL (1+) on the dipstick; if proteinuria is ≥ on the dipstick, 24 hours proteinuria must be <1.5g/24 hours
8. Patient with life expectancy >3 months
9. Female patient, age >18 years
10. Patient weight > 40 kg and BMI >18
11. Female patient of child bearing potential who agrees to use a method of medically acceptable forms of contraception during the study and 3 months after the last intake of study treatment
12. Patient able and willing to comply with study visits and procedures as per protocol
13. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment.
14. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed
15. Patient affiliated to a social security regimen.

1. Pacientka s histologicky alebo cytologicky potvrdenou metastatickou alebo lokálne rozvinutou rakovinou prsníka
2. Pacientka s receptorom hormónov (ER a PR) – pozitívnou a/alebo negatívnou a/alebo neznámym statusom; HER2-pozitívny a/alebo negatívny a/alebo neznámy status (pacientky, ktoré majú neznámy aj negatívny HR alebo HER2 status nie sú vhodné pre štúdiu)
3. Aspoň jedna merateľná lézia podľa definície Hodnotenia odpovedi nádoru na liečbu (RECIST)
4. Pacientka s progresiou po prvej línii liečby u lokálne pokročilého/metastického ochorenia (línia liečby je definovaná ako aspoň jeden normálny cyklus chemoterapie) s antracyklínom a/alebo taxanom (alebo založenom na trastuzumabe, v prípade HER2+)
5. Pacientka vhodná pre prijatie druhej línie chemoterapie vrátane gemcitabínu, karboplatiny a kapecitabínu.
6. ECOG výkonnostný status ≤ 2
7. Pacientka s adekvátnou funkciou orgánov:
• Absolútny počet neutrofilov (ANC) ≥ 1.5 x 109/L
• Hemoglobín ≥ 10 g/dL
• Trombocyty (PTL) ≥ 75 x 109/L
• AST/ALT ≤ 3 x ULN (≤ 5 x ULN v prípade metastáz do pečene)
• Gamma GT ≤ 2.5 x ULN (≤ 5 x ULN v prípade metastáz do pečene)
• Bilirubín ≤ 1.5x ULN (≤ 3 x ULN v prípade metastáz do pečene)
• Normálna hodnota kreatinínu alebo, pokiaľ je kreatinín abnormálny, klírens kreatinínu ≥ 50 mL/min (vzorec Cockcrofta a Gaulta)
• Albumín > 1 x LLN
• Proteinúria < 30 mg/mL (1+) na testovacom prúžku. Pokiaľ je proteinúria na testovacom prúžku ≥ 1+, proteinúria za 24 hodín musí byť < 1.5g/24 hodín
8. Pacientka s očakávanou dĺžkou života > 3 mesiace.
9. Pacientka vo veku ≥ 18 rokov.
10. Váha pacientky > 40 kg a BMI > 18
11. Pacientky vo fertilnom veku (vstupujúce do štúdie po menštruácii a s negatívnym tehotenským testom), ktoré súhlasia s používaním dvoch vysoko účinných metód lekársky prijateľnej antikoncepcie (jedna pre pacientku a jedna pre partnera) počas štúdie a po dobu 3 mesiacov po poslednom podaní liečiva. Prijateľné formy antikoncepcie sú:
• Dokumentované zavedenie vnútromaternicového telieska (IUD) alebo vnútromaternicového systému (IUS) alebo použitie bariérového spôsobu ochrany (kondóm alebo pesar [diafragma alebo cervikálny pesar] v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi)
• Dokumentované podviazanie vaječníkov (ženská sterilizácia). Okrem toho by mal byť tiež používaný bariérový spôsob ochrany (kondóm alebo pesar [diafragma alebo cervikálny pesar] v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi)
• Dvojitá bariérová metóda: Kondóm a okluzívny kryt (diafragma alebo cervikálny pesar) v kombinácii so spermicídnou penou/gélom/krémom/čiapikmi
• Akékoľvek iné metódy antikoncepcie so zdokumentovanou mierou zlyhania < 1 % za rok
• Abstinencia
12. Pacientka schopná a ochotná absolvovať študijné návštevy a procedúry podľa protokolu.
13. Pacientka schopná rozumieť karte pacienta a nasledovať na nej napísané procedúry v prípade príznakov alebo symptómov ťažkej neutropénie alebo ťažkej kožnej toxicity, počas prvých 2 mesiacov liečby.
14. Pacientka schopná rozumieť, podpísať a datovať písomný informovaný súhlas na screeningovej návšteve pred vykonaním akýchkoľvek procedúr daných protokolom. Pokiaľ ošetrujúci lekár usúdi, že kognitívna funkcia pacientky je diskutabilná a oslabená v takej miere, že schopnosť pacientky dať informovaný súhlas je sporná, musí podpísať informovaný súhlas stanovený zákonný zástupca.

E.4

Principal exclusion criteria

1. Patient intolerant to gemcitabine or carboplatin or capecitabine
2. Prior hormonal therapy only as treatment for metastatic disease without chemotherapy. Patients must have received chemotherapy for their metastatic disease in the first-line setting. Hormone therapy alone is not allowed
3. Treatment with more than one prior cytotoxic regimen for metastatic breast disease
4. Patient with Triple Negative metastatic breast cancer
5. 5. Patient presenting with cardiac disorders defined by at least one of the following conditions:
• Patient with recent cardiac history (within 6 months) of:
- Acute coronary syndrome
- Acute heart failure (class III or IV of the NYHA classification)
- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
• Patient with cardiac failure class III or IV of the NYHA classification
• Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
• Syncope without known aetiology within 3 months
• Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
6. Pregnant or nursing female patient
7. Patient presenting at least a grade II peripheral neuropathy
8. Patient treated for a cancer other than breast cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
9. Patient with active central nervous system (CNS) metastasis (i.e. nonprogressive after surgery and/or radiotherapy and/or radiosurgery, without steroids and antiepileptic requirements)
10. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
• Previous treatment
11. Patient treated with any investigational agent within 4 weeks prior baseline.

1. Pacientka intolerantná na gemcitabín alebo karboplatinu alebo kapecitabín
2. Predchádzajúca hormonálna liečba, iba ako liečba metastatického ochorenia bez chemoterapie. Pacientky musia dostať chemoterapiu pre metastatické ochorenie v prvej línii liečby. Samotná hormonálna terapie nie je dovolená. 3. Predchádzajúca liečba s viac než jedným cytotoxickým režimom pre metastatickú rakovinu prsníka.
4. Pacientka s trojito negatívnou metastatickou rakovinou prsníka
5. Pacientky, ktorým boli v posledných 6 mesiacoch zistené tieto ochorenia srdca:
a. Akútny koronárny syndróm
b. Akútne srdcové zlyhanie (triedy III alebo IV podľa klasifikácie NYHA)
c. Výrazná srdcová arytmia (pretrvávajúca komorová tachykardia, fibrilácia komôr, resuscitovaná náhla srdcová smrť).
d. Pacientky so srdcovým zlyhaním triedy III alebo IV podľa klasifikácie NYHA.
e. Pacientky so závažnými poruchami vedenia vzruchu, ktoré nie sú upravené trvalou kardiostimuláciou (atrioventrikulárna blokáda II. a III. stupňa, sinoatriálna blokáda).
f. Synkópa bez známej etiológie v posledných 3 mesiacoch.
g. Nekontrolovaná ťažká hypertenzia podľa posudku skúšajúceho, alebo symptomatická hypertenzia
6. Tehotná alebo dojčiaca žena
7. Pacientky vykazujúce aspoň II stupeň periférnej neuropatie
8. Pacientka liečená s inou rakovinou než rakovinou prsníka v priebehu 5 rokov pred zaradením, s výnimkou rakoviny bazálnych buniek alebo rakovinou krčka maternice in situ
9. Pacientka s metastázami do aktívneho centrálneho nervového systému (CNS) (to je; neprogresívna po operácii a/alebo rádioterapii a/alebo rádiooperácii, bez potreby steroidov a antiepileptík)
10. Pacientky s anamnézou nedôsledného dodržiavania liečby alebo s anamnézou užívania narkotík či alkoholu, alebo nadmerného užívania alkoholu, ktoré by mohlo narušiť dodržiavanie protokolu štúdie, alebo pretrvávajúce či prekonané psychiatrické ochorenie, ktoré by mohlo narušiť dodržiavanie protokolu alebo poskytnutie informovaného súhlasu.
Predchádzajúca liečba

Liečba nesmie začať pre pacientky užívajúce akýkoľvek vyvíjaný liek po dobu 4 týždňov pred baseline

E.5 End points

E.5.1

Primary end point(s)

Overall Survival (OS) is defined as the time from the randomization to the date of documented death due to any cause.

Celkové prežitie (OS) je definované ako čas od randomizácie do času zdokumentovanej smrti z akékoľvek dôvodu.

E.5.1.1

Timepoint(s) of evaluation of this end point

week 24

týždeň 24

E.5.2

Secondary end point(s)

• Survival
o Survival rate at week 6, 12, 18, 24
• Tumour assessment:
o Overall Time to progression (TTP)
o PFS rate every 6 weeks until week 24 and every 12 weeks thereafter
o TTP rate every 4 weeks
o Objective response rate (CR + PR) every 6 weeks until week 24 and every 12 weeks thereafter
o Control disease rate (CR + PR + SD) at week every 6 weeks until week 24 and every 12 weeks thereafter
o Best response during study treatment
• Level of serum CA 15-3 every 6 weeks until week 24 and every 12 weeks thereafter.
• Quality of life assessment according to the EORTC QLQ-C30 questionnaire every 6 weeks until week 24 and every 12 weeks after
• ECOG Performance Status every 6 weeks until week 24 and every 12 weeks after
• Safety profile using the NCI CTC v4.02 classification
• Pharmacokinetics
• CDA activity and pharmacogenomic analysis.

Miera prežitia každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
• Hodnotenie nádoru:
o Celková miera prežitia bez progresie ochorenia (PFS)
o Miera PFS každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
o Miera TTP každé 4 týždne
o Objektívna miera odozvy (CR + PR) každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
o Kontrola ochorenia (CR + PR + SD) každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
o Najlepšia odozva počas liečby
• Hladina séra CA 15-3 každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
• Hodnotenie kvality života podľa dotazníku EORTC QLQ-C30 každých 6 týždňov do týždňov 24 a potom každých 12 týždňa
• ECOG status výkonnosti každých 6 týždňov do týždňa 24 a potom každých 12 týždňov
• Bezpečnostný profil pomocou klasifikácie NCI CTC v4.02
• Farmakokinetika
• CDA aktivita a farmakogenomická analýza

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 6, 12, 18 and 24

týždeň 6, 12, 18 a 24

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

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

Patient could be treated until disease progression, limiting toxicity or consent withdrawal

Pacient môže byť liečený do progresie ochorenia, limitujúcej toxicity alebo do odvolania svojho súhlasu

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

Number of subjects for this age range:

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

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)

NOT DIFFERENT

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-04-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-04-07

P. End of Trial
P.	End of Trial Status	Prohibited by CA

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Orphan Designation Number:
Results Status:
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