Clinical Trials Register

Summary
EudraCT Number:	2014-004281-25
Sponsor's Protocol Code Number:	MLN1117-1501
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-10-10
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-004281-25

A.3

Full title of the trial

A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117
in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Studio adattativo di Fase Ib/II sull’utilizzo di docetaxel in combinazione o meno a MLN1117 in pazienti con tumore al polmone non a piccole cellule localmente avanzato o metastatico

A.3.1

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

A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117
in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Studio adattativo di Fase Ib/II sull’utilizzo di docetaxel in combinazione o meno a MLN1117 in pazienti con tumore al polmone non a piccole cellule localmente avanzato o metastatico

A.3.2

Name or abbreviated title of the trial where available

A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117 in Patients With Locally Adva

Studio adattativo di Fase Ib/II sull’utilizzo di docetaxel in combinazione o meno a MLN1117 in pazie

A.4.1

Sponsor's protocol code number

MLN1117-1501

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02393209

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	MILLENNIUM PHARMACEUTICALS, INC.
B.1.3.4	Country	United States
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	Millennium Pharmaceuticals, Inc. - Stati Uniti d'America
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Millennium Pharmaceuticals, Inc.
B.5.2	Functional name of contact point	Hess Suh
B.5.3	Address:
B.5.3.1	Street Address	40 Landsdowne Street
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	02139
B.5.3.4	Country	United States
B.5.4	Telephone number	1 617 444 4341
B.5.5	Fax number	1 617 444 4341
B.5.6	E-mail	HaeSuk.Suh@takeda.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	MLN1117
D.3.2	Product code	MLN1117
D.3.4	Pharmaceutical form	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	MLN1117
D.3.9.2	Current sponsor code	MLN1117
D.3.9.3	Other descriptive name	MLN1117
D.3.9.4	EV Substance Code	SUB126088
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.3.11 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	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	MLN1117
D.3.2	Product code	MLN1117
D.3.4	Pharmaceutical form	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	MLN1117
D.3.9.2	Current sponsor code	MLN1117
D.3.9.3	Other descriptive name	MLN1117
D.3.9.4	EV Substance Code	SUB126088
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	300
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	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.2.1.1.1	Trade name	DOCETAXEL ACTAVIS - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO MONODOSE DA 1 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ACTAVIS GROUP PTC EHF
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.2	Product code	docetaxel
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	DOCETAXEL
D.3.9.1	CAS number	1268454-23-4
D.3.9.4	EV Substance Code	SUB12492MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

non-small cell lung cancer (NSCLC)

tumore al polmone non a piccole cellule (NSCLC)

E.1.1.1

Medical condition in easily understood language

non-small cell lung cancer (NSCLC)

tumore al polmone non a piccole cellule (NSCLC)

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	10059515
E.1.2	Term	Non-small cell lung cancer metastatic
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

Phase 2: To evaluate progression-free survival (PFS) as the primary efficacy measure of MLN1117 plus docetaxel versus docetaxel alone in patients with advanced NSCLC

Fase 2: Valutare la sopravvivenza libera da progressione (PFS) come misura di efficacia primaria di MLN1117 più docetaxel rispetto a docetaxel da solo in pazienti con NSCLC avanzato

E.2.2

Secondary objectives of the trial

PHASE 2:
- To evaluate the safety and tolerability of MLN1117 plus docetaxel administered to patients with NSCLC
- To evaluate the PK of MLN1117 when dministered with docetaxel
- To evaluate additional efficacy measures, such as response rate (RR), disease control rate, response duration, time to progression (TTP), and OS, of MLN1117 plus docetaxel versus docetaxel alone in patients with NSCLC
- To evaluate PFS and additional efficacy measures of MLN1117 plus docetaxel versus docetaxel alone in different populations of patients with NSCLC, such as patients with squamous NSCLC versus
nonsquamous NSCLC, and patients with squamous NSCLC with or without PIK3CA mutation and/or amplification (MUT/AMP)

FASE 2:
- valutare la sicurezza e la tollerabilità di MLN1117 più docetaxel
somministrato a pazienti con NSCLC
- Valutare la PK di MLN1117 quando somministrato con docetaxel
- Valutare le misure di efficacia aggiuntive, come il tasso di risposta (RR),
tasso di controllo della malattia, la durata della risposta, il tempo alla progressione (TTP), e
OS, di MLN1117 più docetaxel rispetto al solo docetaxel in pazienti con
NSCLC
- Valutare PFS e misure di efficacia addizionali di MLN1117 più docetaxel rispetto al solo docetaxel in diverse popolazioni di pazienti con NSCLC, come i pazienti con NSCLC squamoso contro NSCLC non squamoso, e pazienti con NSCLC squamoso con o senza mutazioni e/o amplificazione (MUT / AMP) di PIK3CA

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Has a histologically and/or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous).
•For Phase 2, has a diagnosis of mixed squamous and nonsquamous (or adenosquamous) NSLC.
•Has locally advanced or metastatic disease (Stage IIIb or Stage IV) with radiographically or clinically evaluable lesions.
•Has experienced failure of at least 1 prior chemotherapy regimen.
•For Phase 2, has received 1 prior platinum-based chemotherapy regimen (excluding a docetaxel containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) disease followed by documented progressive disease.
•For Phase 2, has archived or fresh tumor biopsy samples obtained during screening sufficient for genotyping.
•Has adequate organ function, before the first dose of study drug.
•Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•Female participants who are postmenopausal for at least 1 year before the screening visit or are surgically sterile, or are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true
abstinence.
•Male participants agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence.
•Has suitable venous access for the study-required blood sampling.
•Has recovered (ie, <= Grade 1 toxicity or eligibility per this protocol is met) from the reversible effects of prior anticancer therapy.

• diagnosi istologicamente e/o citologicamente confermata di NSCLC (squamoso o non squamoso).
• Per la fase 2, diagnosi di NSLC misto squamoso e non squamoso (o adenosquamoso).
• malattia metastatica o localmente avanzata (stadio IIIb o stadio IV) con lesioni radiologicamente o clinicamente valutabili.
• fallimento di almeno 1 precedente regime chemioterapico.
• Per la fase 2, ha ricevuto 1 precedente regime chemioterapico a base di platino (esclusione di un regime contenente docetaxel) per malattia avanzata o metastatica seguita da documentata progressione della malattia (stadio IIIb o stadio IV).
• Per la fase 2, sono presenti campioni bioptici tumorali freschi o archiviati ottenuti durante lo screening sufficienti per la genotipizzazione.
• adeguata funzionalità dell’organo, prima della prima dose del farmaco in studio.
• ECOG Performance Status di 0 o 1.
• partecipanti donne in menopausa da almeno 1 anno prima della visita di screening o che sono chirurgicamente sterili, o che sono in età fertile e accettano di utilizzare 2 metodi contraccettivi efficaci, allo stesso tempo, dal momento della firma del consenso informato fino a 30 giorni dopo l'ultima dose del farmaco in studio, o accettare di praticare vera astinenza.
• i partecipanti maschi si impegnano ad utilizzare efficaci metodi contraccettivi a barriera durante l'intero periodo di trattamento dello studio e fino a 120 giorni dopo l'ultima dose di farmaco in studio, o ad accettare di praticare l'astinenza vero.
• accesso venoso adatto per il campionamento di sangue richiesto dallo studio.
• recupero (cioè, <= 1 grado di tossicità o di ammissibilità per questo protocollo è soddisfatto) dagli effetti reversibili della terapia antitumorale precedente.

E.4

Principal exclusion criteria

•Previous treatment with a PI3K or AKT inhibitor.
•Prior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before
the first administration of study drug, and the patient must have documented progressive disease.
•Has poorly controlled diabetes mellitus defined as HbA1c > 6.5%.
•Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
•Has taken histamine-H2 receptor antagonists and/or neutralizing antacids within 24 hours before the first administration of study drug.
•Has taken proton pump inhibitors within 7 days before the first administration of study drug.
•Has any clinically significant co-morbidities.
•Has acute myocardial infarction within 6 months before starting study drug, current or history of New York Heart Association Class III or IV heart failure, Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or ECG evidence of acute ischemia or active conduction system abnormalities,
Fridericia's corrected QT interval > 475 milliseconds (msec) (males) or > 450 msec (females) on a 12-lead ECG during the Screening period, or abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant.
•Has known, previously diagnosed human immunodeficiency virus infection or active chronic hepatitis B or C.
•Has brain metastasis, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and do not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•Has active secondary malignancy that requires treatment.
•Has any serious medical or psychiatric illness, including drug or alcohol abuse.
•Male participants who intend to donate sperm during the course of this study or 120 days after receiving their last dose of study drug.
•Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive
urine pregnancy test on Day 1 before administration of the first dose of study drug

• precedente trattamento con un inibitore della PI3K o AKT.
• precedente terapia anticancro o altre terapie sperimentali entro 2 settimane prima della prima somministrazione del farmaco in studio o mancata ripresa dagli effetti reversibili di terapie antitumorali precedenti. Per terapie precedenti con una emivita più di 3 giorni, l'intervallo deve essere di almeno 28 giorni prima della prima somministrazione del farmaco in studio, e il paziente deve presentare documentata malattia progressiva.
• diabete mellito mal controllato definito come HbA1c> 6,5%.
• somministrazione di potenti inibitori o potenti induttori del CYP3A4 entro 14 giorni prima della prima dose del farmaco in studio.
• somministrazione di antagonisti dei recettori dell'istamina H2 e/o antiacidi neutralizzanti entro 24 ore prima della prima somministrazione del farmaco in studio.
• somministrazione di inibitori della pompa protonica entro 7 giorni prima della prima somministrazione del farmaco in studio.
• eventuali clinicamente significative comorbidità.
• infarto miocardico acuto entro 6 mesi prima di iniziare il farmaco in studio, in corso o storia di insufficienza cardiaca di classe III o IV secondo New York Heart Association, Evidenza di malattie cardiovascolari non controllate in corso compresi aritmie cardiache, angina, ipertensione polmonare, o evidenza all’ECG di ischemia acuta o anomalie attive del sistema di conduzione, intervallo QT corretto di Fridericia> 475 millisecondi (msec) (maschi) o> 450 msec (femmine) su un ECG a 12 derivazioni durante il periodo di screening, o anomalie di ECG a 12 derivazioni, tra cui, ma non limitati a, variazioni di ritmo e intervalli che a giudizio dello sperimentatore sono considerati clinicamente significativi.
• conosciuta e in precedenza diagnosticata infezione da virus dell'immunodeficienza umana o epatite cronica B o C attiva.
• metastasi cerebrali, fatta eccezione per quei pazienti che hanno completato la terapia definitiva, non sono sotto steroidi, hanno uno stato neurologico stabile per almeno 2 settimane dopo il completamento della terapia definitiva e steroidi, e non hanno una disfunzione neurologica che confonda la valutazione neurologica e di altri eventi avversi.
• tumore maligno secondario attivo che richiede un trattamento.
• malattia medica o psichiatrica grave, tra cui droga o alcol.
• partecipanti maschi che intendono donare sperma durante il corso di questo studio o 120 giorni dopo la ricezione loro ultima dose del farmaco in studio.
• partecipanti donne che stanno allattando e che presentino test di gravidanza sul siero positivo durante il periodo di screening o test di gravidanza sulle urine positivo al giorno 1 prima della somministrazione della prima dose del farmaco in studio

E.5 End points

E.5.1

Primary end point(s)

Progress-Free Survival

Sopravvivenza libera da progressione

E.5.1.1

Timepoint(s) of evaluation of this end point

DLTs, MTD, and RP2D may occur at any time. PFS data will be collected during the posttreatment follow-up period of up to 6 months after the last dose of study drug

DLT, MTD, e RP2D può verificarsi in qualsiasi momento. Dati PFS saranno raccolti durante il periodo di follow-up post-trattamento fino a 6 mesi dopo l'ultima dose del farmaco in studio

E.5.2

Secondary end point(s)

Endpoints for phase 2 - Safety: o Vital signs o Physical examination findings o 12-lead ECG o Clinical laboratory test results o AEs and SAEs - Response rate (complete response [CR] + partial response [PR]), disease control rate (CR + PR + stable disease [SD]), duration of response (DOR), and TTP - Overall Survival - MLN1117 plasma concentrations when administered 1 day after docetaxel - Exploratory endpoints o Correlation between PIK3CA and/or other mutations detected in circulating tumor DNA and tumor tissue DNA o Correlation between the amount of and allelic frequencies of PIK3CA and/or othermutations detected in circulating tumor DNA and clinical response o Genetic polymorphisms in genes encoding drug metabolizing enzymes and/or transporters on the PK of MLN1117 and/or in genes related to clinical response and/or study drug-related toxicity o HRQOL, physical functioning, and other effects of the disease and/or therapy as measured by the PRO instruments the EORTC QLQ-C30(1, 2) and the EORTC QLQLC-13(3)

Endpoint per la fase 2 - Sicurezza: o segni vitali o risultati dell'esame fisico o ECG a 12 derivazioni o risultati dei test di laboratorio clinico o eventi avversi e avversi gravi - Tasso di risposta (risposta completa [CR] + risposta parziale [PR]), tasso di controllo della malattia (CR + PR + malattia stabile [SD]), durata della risposta (DOR), e TTP - sopravvivenza complessiva - concentrazioni plasmatiche di MLN1117 quando somministrato 1 giorno dopo docetaxel - Endpoint esplorativi o Correlazione tra PIK3CA e/o altre mutazioni rilevate nel DNA tumorale circolante e DNA tumorale del tessuto o correlazione tra la quantità di frequenze alleliche e di PIK3CA e/o altre mutazioni del DNA tumorale circolante rilevate e la risposta clinica o polimorfismi genetici in geni che codificano per enzimi metabolizzanti i farmaci e/o trasportatori sulla PK di MLN1117 e/o in geni legati alla risposta clinica e/o alla tossicità correlata al farmaco di studio o HRQOL, funzionalità fisica, e altri effetti della malattia e/o della terapia come misurato dagli strumenti PRO EORTC QLQ-C30 (1, 2) e EORTC QLQLC-13 (3)

E.5.2.1

Timepoint(s) of evaluation of this end point

Any time during phase II of the study

In qualsiasi momento durante la fase II dello studio

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

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

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

Yes

E.6.13.1

Other scope of the trial description

Genetic testing

Test genetici

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

expans combined treat dose

espansione dose trattamento combinato

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

Yes

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Italy

Netherlands

Norway

Spain

United Kingdom

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 will be terminated 6 months after the last patient completes an EOT study visit

Lo studio sarà conclusa 6 mesi dopo che l'ultimo paziente compie la visita di fine studio

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:

130

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

155

F.5

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

none

nessuno

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

2015-09-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-09-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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