Clinical Trials Register

Summary
EudraCT Number:	2011-005524-17
Sponsor's Protocol Code Number:	CBKM120F2302
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:	2012-09-03
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-005524-17

A.3

Full title of the trial

A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment

Studio randomizzato, in doppio cieco, controllato versus placebo, di Fase III, con BKM120 in associazione a fulvestrant in pazienti in post-menopausa con carcinoma mammario positivo per i recettori ormonali HER2 negativo localmente avanzato o metastatico che ha presentato progressione durante o dopo terapia con inibitori dell'aromatasi

A.3.1

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

A phase III study of BKM120 with fulvestrant in postmenopausal patients with hormone receptor + HER2-locally advanced or metatstatic breast cancer refractory to aromatase inhibitors

Studio di Fase III con BKM120 in associazione a fulvestrant in pazienti in post-menopausa con carcinoma mammario positivo per i recettori ormonali HER2 negativo localmente avanzato o metastatico refrattario agli inibitori dell’aromatasi

A.3.2

Name or abbreviated title of the trial where available

BELLE 2

A.4.1

Sponsor's protocol code number

CBKM120F2302

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	NOVARTIS FARMA
B.1.3.4	Country	Italy
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	Novartis Pharma Services AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	NOVARTIS FARMA
B.5.2	Functional name of contact point	Drug Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Largo Umberto Boccioni, 1
B.5.3.2	Town/ city	ORIGGIO
B.5.3.3	Post code	21040
B.5.3.4	Country	Italy
B.5.4	Telephone number	02-96541
B.5.5	Fax number	02-9659066
B.5.6	E-mail	info.studiclinici@novartis.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	NA
D.3.2	Product code	BKM120
D.3.4	Pharmaceutical form	Capsule, hard
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.3.9.2	Current sponsor code	BKM120
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	10
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	NA
D.3.2	Product code	BKM120
D.3.4	Pharmaceutical form	Capsule, hard
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.3.9.2	Current sponsor code	BKM120
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	50
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	FASLODEX*IM 2SIR 5ML+2AGHI
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA SpA
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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FULVESTRANT
D.3.9.1	CAS number	129453-61-8
D.3.9.4	EV Substance Code	SUB13933MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hormone receptor-positive HER2 negative locally advanced or metastatic breast cancer

Carcinoma mammario positivo per i recettori ormonali HER2 negativo localmente avanzato o metastatico

E.1.1.1

Medical condition in easily understood language

Hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer

Carcinoma mammario positivo per i recettori ormonali HER2 negativo localmente avanzato o metastatico

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	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
E.1.2	System Organ Class	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

To assess the treatment effect of BKM120 once daily plus fulvestrant versus BKM120 matching placebo once daily plus fulvestrant on progression-free survival (PFS)

Determinare se il trattamento con BKM120 in associazione a fulvestrant prolunga la PFS, determinata in base alla valutazione locale da parte dello sperimentatore, in confronto al trattamento con placebo in associazione a fulvestrant in tutte le pazienti indipendentemente dallo stato di attivazione della via di PI3K (popolazione completa) e nella sottopopolazione con attivazione della via di PI3K.

E.2.2

Secondary objectives of the trial

To evaluate BKM120 once daily plus fulvestrant versus BKM120 matching placebo once daily plus fulvestrant with respect to • Overall survival (OS) • Overall response rate (ORR) • Clinical benefit rate (CBR) Safety • To characterize the pharmacokinetics of BKM120 given in combination with fulvestrant Patients health related quality of life

Valutare il trattamento con BKM120 una volta al giorno in associazione a fulvestrant in confronto al trattamento con placebo in associazione a fulvestrant rispetto a: - sopravvivenza globale (OS) - tasso di risposta globale (ORR) - tasso di beneficio clinico (CBR) - Sicurezza d’impiego in tutte le pazienti - Farmacocinetica di BKM120 e fulvestrant somministrati in associazione - Valutazione della qualità della vita

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

OTHER SUBSTUDIES:
Biomarkers assessment:1.additional biopsies and blood tests;2.samples remaining after the end of analisis.For more details refer to protocol

ALTRI SOTTOSTUDI:
Indagini complementari di valutazione degli indicatori biologici:1.su biopsia ed esami del sangue aggiuntivi;2.su campioni rimanenti dopo la fine delle analisi.Fare riferimento al prot. di studio

E.3

Principal inclusion criteria

- Breast cancer that is locally advanced or metastatic - HER2 negative disease, hormone receptor positive status (common breast cancer classification tests) - postmenopausal woman - A tumor sample must be shipped to novartis designed laboratory for identification of biomarkers (PI3K activation status) - Progression recurrence of breast cancer hile on after aromatase inhibitor treatment - Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1

1.Pazienti adulte di età >= 18 anni al momento del consenso informato;2.Pazienti con diagnosi istologica/citologica confermata di carcinoma mammario;3.Pazienti che hanno a disposizione tessuto tumorale archiviato per l’analisi degli indicatori biologici correlati a PI3K.Per determinare lo status dell’attivazione della via di PI3K è raccomandabile avere a disposizione un blocco o un minimo di 20 vetrini non colorati.L’arruolamento nello studio dipenderà dalla conferma del laboratorio centralizzato della ricezione di quantità di tessuto adeguate;4.Pazienti con carcinoma mammario non operabile in stadio localmente avanzato o metastatico;5.Pazienti con carcinoma mammario con negatività per HER2 definita da: immunoistochimica negativa, ibridizzazione in situ fluorescente,non fluorescente cromogenica o Silver negativa) o immunoistochimica dello stato recettoriale di 0, 1+ o 2+ eseguiti dal laboratorio locale;6.Pazienti con carcinoma mammario con positività ER e/o positività PgR mediante analisi del laboratorio locale;7.Pazienti in post-menopausa;8.Le pazienti presentano una refrattarietà alla terapia con inibitori delle aromatasi;9.Pazienti che possono deglutire e trattenere farmaci per via orale; 10.Evidenza radiologica oppure obiettiva di recidiva o progressione durante o dopo l’ultima terapia sistemica prima dell’arruolamento nella fase di run-in del trattamento;11.Le pazienti devono presentare, secondo RECIST 1.1 malattia misurabile oppure lesioni ossee non misurabili litiche o miste in assenza di malattia misurabile;12.Pazienti con funzionalità midollare e organica adeguata;13.Pazienti con Eastern Cooperative Oncology Group (ECOG) performance status <= 2 ritenuto dallo sperimentatore stabile al momento dello screening;14.Pazienti che hanno firmato il consenso informato scritto prima dell’inizio di qualsiasi procedura di screening e in conformità alle linee-guida locali.Per maggiori dettagli fare riferimento al paragrafo 5.2 del protocollo.

E.4

Principal exclusion criteria

- Prior chemotherapy for locally advanced or metastatic disease - Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitors, fulvestrant - More than one prior chemotherapy line for metastatic disease - Symptomatic brain metastases - Concurrent malignancy or malignancy within 3 years prior to start of study treatment - Certain drugs or radiation within 2-4 weeks of enrollment - Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent - Active heart (cardiac) disease as defined in the protocol - Certain scores on an anxiety and depression mood questionaire given at screening Other protocol defined criteria may apply

1.Pazienti sottoposte a trattamento precedente con inibitori di PI3K,inibitori di AKT, inibitori di mTOR o fulvestrant;2.Pazienti sottoposte a più di una linea di chemioterapia per la malattia metastatica;3.Pazienti con un’ipersensibilità nota a uno qualsiasi degli eccipienti di BKM120 o fulvestrant;4.Pazienti con metastasi sintomatiche del SNC;5.Evidenza attuale o pregressa di altra neoplasia nei 3 anni precedenti l’arruolamento nello studio;6.Pazienti sottoposte a radioterapia ad ampio campo <= 4 settimane o radioterapia palliativa a campo limitato <= 2 settimane prima dell’inizio del trattamento in studio che non hanno presentato risoluzione a Grado 1 o inferiore degli effetti collaterali di tale terapia;7.Pazienti che non hanno presentato risoluzione a Grado 1 o inferiore degli effetti collaterali di qualsiasi terapia antitumorale precedente;8. Pazienti sottoposte a intervento chirurgico maggiore nei 14 giorni precedenti l’inizio del trattamento in studio o che non hanno presentato guarigione dagli effetti collaterali di tale procedura;9.Pazienti che sono in terapia attuale con un dosaggio crescente o cronico di corticosteroidi o altri farmaci immunosoppressori poiché la somministrazione cronica di corticosteroidi (> 5 giorni) può indurre il CYP3A4;10.Pazienti in trattamento attuale con warfarin o con altro anticoagulante derivato coumarinico per il trattamento, la profilassi o per altro motivo. E’ consentito il trattamento con eparina, eparina a basso peso molecolare (LMWH) o fondaparinux;11.Pazienti in trattamento attuale con farmaci noti per essere inibitori o induttori forti o moderati degli isoenzimi CYP3A;12.Pazienti con un punteggio >= 12 al questionario PHQ-9;13.Pazienti che selezionano le risposte “1”, “2” o “3” alla domanda numero 9 del questionario PHQ-9, riguardo a potenziali pensieri o ideazione suicidaria;14.Pazienti con un punteggio alla scala GAD-7 per la valutazione del tono dell’umore >= 15;15.Pazienti con un’anamnesi documentata di episodio di depressione maggiore, disturbo bipolare, disturbo ossessivo compulsivo, schizofrenia, anamnesi positiva per tentativi di suicidio o ideazione suicidaria o ideazione omicida;16.Pazienti con ansia di grado CTCAE >= 3;17.Evidenza clinica attuale di cardiopatia o evidenza pregressa di alterazioni della funzionalità cardiaca;18. Pazienti con una frazione di eiezione del ventricolo sinistro (LVEF) < 50%, determinata mediante Multiple Gated Acquisition (MUGA) scan o ecocardiogramma (ECHO).Per maggiori dettagli fare riferimento al paragrafo 5.3 del protocollo.

E.5 End points

E.5.1

Primary end point(s)

PFS in the PI3K pathway activated sub-population and full population.

PFS nella popolazione completa e nella sottopopolazione con via di PI3K attivata in base alla valutazione locale da parte dello sperimentatore.

E.5.1.1

Timepoint(s) of evaluation of this end point

every 8 weeks after randomisation

Ogni 8 settimane dopo la randomizzazione

E.5.2

Secondary end point(s)

- OS, defined as time from date of randomization to the date of death from any cause - ORR, defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) as defined in Appendix 6 (RECIST 1.1) - Clinical benefit rate (CBR) is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in Appendix 6 (RECIST 1.1) - Safety: Type, frequency and severity of adverse events per CTCAEv4.03; type, frequency and severity of laboratory toxicities per CTCAEv4.03 - Summary statistics for PK: plasma concentration-time profiles of BKM120 and fulvestrant appropriate PK parameters

-OS nella popolazione completa e nella sottopopolazione con via di PI3K attivata;-ORR nella popolazione completa e nella sottopopolazione con via di PI3K attivata e nella sottopopolazione con via di PI3K non attivata/non nota;-Tasso di beneficio clinico nella popolazione completa e nella sottopopolazione con via di PI3K attivata e nella sottopopolazione con via di PI3K non attivata/non nota;-PFS nella sottopopolazione con via di PI3K non attivata/non nota in base alla valutazione locale da parte dello sperimentatore;-OS nella sottopopolazione con via di PI3K non attivata/non nota;-Tipo, incidenza e gravità degli eventi avversi in base a CTCAEv4.03. Tipo, incidenza e gravità delle alterazioni dei valori degli esami di laboratorio in base a CTCAEv4.03;-Statistiche riassuntive per la farmacocinetica allo steady state: profili del rapporto concentrazione plasmatica/tempo di BKM120 e parametri farmacocinetici individuali appropriati (AUCtau, Cmax, Tmax e altri parametri farmacocinetici, se ritenuto appropriato);-Statistiche descrittive per la farmacocinetica: profili concentrazione plasmatica/tempo di BKM120 somministrato in associazione a fulvestrant e parametri farmacocinetici individuali appropriati basati su modelli di farmacocinetica di popolazione.Statistiche descrittive della concentrazione plasmatica trough di fulvestrant;-Tempo al deterioramento del 10% dello stato di salute complessivo/punteggio alla scala di valutazione della qualità della vita dell’EORTC QLQ-C30.

E.5.2.1

Timepoint(s) of evaluation of this end point

- every 3 months after end of treatment OS - estimated 8 weeks after randomisation ORR - estimated 8 weeks after randomisation CBR - contiuous safety - at each cycle specific days defined in protocol

-Ogni 3 mesi dopo la fine del trattamento OS;-8 settimane stimate dopo la randomizzazione ORR; - 8 settimane stimate dopo la randomizzazione CBR;-continuamente la sicurezza;-a giorni specifici di ogni ciclo specifici definiti dal protocollo

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

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

118

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

Argentina

Australia

Brazil

China

Israel

Japan

Korea, Republic of

Peru

Russian Federation

Singapore

South Africa

Switzerland

Taiwan

Thailand

Turkey

United States

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 End of Study is defined as the time point when data collection will stop and the final analysis of the study will occur. The End of Study will be declared depending on the results of the primary analysis.

Data in cui termina la raccolta dei dati e si effettua l’analisi finale dello studio. La fine dello studio sarà dichiarato in base ai risultati dell'analisi primaria.

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:

506

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

336

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

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

373

F.4.2.2

In the whole clinical trial

842

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)

After discontinuing study treatment, further treatment is left to the physician's discretion. No cross over to the BKM120 arm will be allowed.

Dopo la sospensione del trattamento di studio, sarà discrezione del medico decidere l'ulteriore trattamento. Non sarà consentito il cross over al braccio BKM120.

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

2012-09-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-17

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2017-05-03

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