Clinical Trials Register

Summary
EudraCT Number:	2013-001110-15
Sponsor's Protocol Code Number:	1280.4
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-02-24
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

Spain - AEMPS

A.2

EudraCT number

2013-001110-15

A.3

Full title of the trial

A Phase Ib/II Randomized Study of BI 836845 in Combination with Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women with Locally Advanced or Metastatic Breast Cancer

Ensayo clínico de Fase Ib/II, aleatorizado, de BI 836845 en combinación con Exemestano y Everolimus frente a Exemestano y Everolimus en mujeres con cáncer de mama localmente avanzado o metastásico

A.3.1

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

BI 836845 in estrogen receptor positive metastatic breast cancer

BI 836845 en cáncer de mama metastásico positivo para el receptor de estrógeno

A.4.1

Sponsor's protocol code number

1280.4

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	Boehringer Ingelheim España, S.A.
B.1.3.4	Country	Spain
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	Boehringer Ingelheim España. S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Boehringer Ingelheim Pharma GmbH & Co. KG
B.5.2	Functional name of contact point	QRPE PSC CT Information Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Binger Strasse 173
B.5.3.2	Town/ city	Ingelheim am Rhein
B.5.3.3	Post code	55216
B.5.3.4	Country	Germany
B.5.4	Telephone number	+1 800 243 0127
B.5.5	Fax number	+1 800 821 7119
B.5.6	E-mail	clintriage.rdg@boehringer-ingelheim.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.3.2	Product code	BI 836845
D.3.4	Pharmaceutical form	Concentrate for solution for injection/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	not yet assigned
D.3.9.2	Current sponsor code	BI 836845
D.3.9.3	Other descriptive name	BI 836845
D.3.9.4	EV Substance Code	SUB122634
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	1000
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)	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	Yes
D.3.11.13.1	Other medicinal product type	Fully human monoclonal antibody (HumAb) of the IgG1 isotype
D.IMP: 2
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	Afinitor 2,5 mg Tabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	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	Everolimus
D.3.9.1	CAS number	159351-69-6
D.3.9.3	Other descriptive name	EVEROLIMUS
D.3.9.4	EV Substance Code	SUB02065MIG
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	2.5
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	Afinitor 5 mg Tabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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
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	Everolimus
D.3.9.1	CAS number	159351-69-6
D.3.9.3	Other descriptive name	EVEROLIMUS
D.3.9.4	EV Substance Code	SUB02065MIG
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	5
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

Locally Advanced or Metastatic Breast Cancer positive for estrogen-receptor (ER) and/or progesterone receptor (PgR) and negative for HER2 which is refractory to non-steroidal aromatase inhibitor (letrozole and/or anastrozole)

Cáncer de mama localmente avanzado o metastásico positivo para el receptor de estrógeno (ER) y/o el receptor de progesterona (PgR) y negativo para HER2 negativo que es resistente a inhibidores de la aromatasa no esteroideos (letrozol y/o anastrozol)

E.1.1.1

Medical condition in easily understood language

advanced breast cancer overexpressing hormone receptors (like estrogen)

Cáncer de mama avanzado en el que se sobreexpresan receptores de hormonas (como estrógeno)

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10070575
E.1.2	Term	Estrogen receptor positive 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

Phase I part: To determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer.
Phase II part: To evaluate the antitumor activity of BI 836845 in combination with exemestane and everolimus compared to exemestane and everolimus alone in women with HR+/HER2- advanced breast cancer.

Fase I: Determinar la dosis máxima tolerada (MTD) y la dosis recomendada para la fase II de BI 836845 en combinación con exemestano y everolimus en mujeres con cáncer de mama localmente avanzado o metastásico HR+/HER2-.
Fase II: Evaluar la actividad antitumoral de BI 836845 en combinación con exemestano y everolimus frente a exemestano y everolimus en mujeres con cáncer de mama localmente avanzado o metastásico HR+/HER2-.

E.2.2

Secondary objectives of the trial

To determine the safety of BI 836845 in combination with exemestane and everolimus in HR+/HER2- advanced breast cancer patients.

Determinar la seguridad de BI 836845 en combinación con exemestano y everolimus en pacientes con cáncer de mama avanzado HR+/HER2-.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Histologically-confirmed locally advanced (aBC) or metastatic breast cancer (mBC) not deemed amenable to curative surgery or curative radiation therapy
-Tumors are positive for estrogen-receptor (ER) and/or progesterone receptor (PgR).
-Tumors must be negative for HER2 per local lab testing.
-Must have adequate archival tumor tissue from surgery or biopsy.
- Postmenopausal women.
-Objective evidence of recurrence or progressive disease on or after the last line of systemic therapy for breast cancer prior to study entry
- The patient is disease refractory to non-steroidal aromatase inhibitor (letrozole and/or anastrozole)
- Patients must have measurable lesion according to RECIST version 1.1 or bone lesions only: lytic or mixed (lytic + sclerotic) in the absence of measurable lesion as defined above
- Eastern Cooperative Oncology Group performance score <= 2.
- Life expectancy of >= 6 months in the opinion of the investigator
- Fasting plasma glucose < 8.9 mmol/L (< 160 mg/dL) and HbA1c < 8.0%
- Adequate organ function
- Recovered from any previous therapy related toxicity to <= Grade 1 at study entry (except for stable sensory neuropathy <=Grade 2 and alopecia)
- Written informed consent that is consistent with ICH-GCP guidelines and local regulations

Inclusion criteria for the biopsy substudy are identical to the main study of the phase II part except for the following two inclusion criteria:
- Fresh tumor biopsy should be taken when deemed safe and feasible by the investigator and upon informed consent by the patient. Bone lesion is not recommended for biopsy
- Patients eligible to undergo tumor biopsy should have normal coagulation parameters (INR and PTT within normal range)

- Cáncer de mama localmente avanzado o metastásico confirmado histológicamente y considerado no susceptible a cirugía o radioterapia curativas
- Tumores positivos para el receptor de estrógeno (ER) y/o el receptor de progesterona (PgR);
- Los tumores deben ser negativos para HER2 según pruebas de un laboratorio local
- Se debe disponer de tejido tumoral archivado de una biopsia o intervención quirúrgica
- Mujeres posmenopáusicas
- Indicios objetivos de recidiva o de progresión de la enfermedad durante o después de un tratamiento sistémico de última línea para el cáncer de mama antes de la entrada en el estudio
- Enfermedad resistente a inhibidores de la aromatasa no esteroideos (letrozol y/o anastrozol)
- Las pacientes deben presentar una lesión medible de acuerdo con los criterios RECIST versión 1.1 o, en ausencia de una lesión medible, solo lesiones óseas: líticas o mixtas (líticas + escleróticas)
- Puntuación del estado funcional según la escala ECOG (Eastern Cooperative Oncology Group, R01-0787) ? 2
- Esperanza de vida de ? 6 meses en opinión del investigador
- Glucosa plasmática < 8,9 mmol/l (< 160 mg/dl) y HbA1c < 8,0% determinadas en ayunas
- Función de los órganos suficiente
- Recuperación de cualquier toxicidad relacionada con un tratamiento previo a grado ? 1 en el momento de su entrada en el estudio (excepto en caso de neuropatía sensorial estable de grado ? 2 y alopecia)
- Consentimiento informado por escrito conforme a las normas de BPC de la ICH y a la legislación local

Los criterios de inclusión para el subestudio de la biopsia son los mismos que los de la fase II del estudio principal, exceptuando los dos criterios de inclusión que se indican a continuación:
- La biopsia del tumor en fresco debe realizarse cuando se haya obtenido el consentimiento informado de la paciente y el investigador considere que es un procedimiento seguro y viable. No se recomienda biopsiar una lesión ósea
- Las pacientes aptas para someterse a una biopsia del tumor deben presentar parámetros de coagulación normales (INR y PTT dentro del intervalo normal)

E.4

Principal exclusion criteria

- Previous treatment with agents targeting on IGF pathway, phosphoinositide 3-kinase (PI3K) signaling pathway, protein kinase B (AKT), or mammalian target of rapamycin (mTOR) pathways
- Prior treatment with exemestane
- Known hypersensitivity to monoclonal antibody, mTOR inhibitors (e.g. sirolimus), or to the excipients of any study drugs
- Ovarian suppression by ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist
- Less than one week after receiving immunization with attenuated live vaccines prior to study treatment
- Radiotherapy within 4 weeks prior to run-in treatment, except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to study treatment
- Chemotherapy, biological therapy (other than bevacizumab), immunotherapy or investigational agents within 5 half-life of the drug or within two weeks prior to the start of study treatment, whichever is longer; bevacizumab treatment within 4 weeks prior to start of study treatment
- Hormonal treatment for breast cancer within 2 weeks prior to start of study treatment
- Major surgery in the judgement of the investigator within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study
- Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use except Topical applications, inhaled sprays, eye drops or local injections or Patients on stable low dose of corticosteroids for at least two weeks before study entry
- Chronic hepatitis B infection, chronic hepatitis C infection and/or known HIV carrier
- QTcF prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator
- Disease that is considered by the investigator to be rapidly progressing or life threatening such as extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor
- History of brain or other CNS metastases
- Bilateral diffuse lymphangitic carcinomatosis
- Hypokalemia of Grade >1
- History of another primary malignancy within 5 years, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
- Family history of long QT syndrome
- Any concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety and anti-tumor activity of the test drug(s)
- Patients being treated with drugs recognized being strong or moderate CYP3A4 and/or PgP inhibitors and/or strong CYP3A4 inducers within 2 weeks prior to study entry
- Patients received more than two lines of chemotherapy for locally advanced or metastatic breast cancer (For the Phase II: more than one line)

- Tratamiento previo con fármacos dirigidos contra la vía de IGF, la vía de señalización de la fosfoinositol 3-quinasa (PI3K), la proteína quinasa B (AKT) o las vías de la diana de la rapamicina en mamíferos (mTOR) (sirolimus, temsirolimus, etc.)
- Tratamiento previo con exemestano
- Hipersensibilidad conocida a un anticuerpo monoclonal, a inhibidores de mTOR (p. ej., sirolimus) o a los excipientes de alguno de los fármacos del estudio
- Supresión ovárica debida a radiación ovárica o al tratamiento con un agonista de la hormona liberadora de hormona luteinizante (LH-RH)
- Vacunación con virus vivos atenuados menos de una semana antes del tratamiento del estudio
- Radioterapia en las 4 semanas previas al tratamiento de preinclusión, excepto en el caso de radioterapia localizada con fines analgésicos o para lesiones líticas con riesgo de fractura, que se puede finalizar en las dos semanas previas al inicio del tratamiento del estudio
- Quimioterapia, bioterapia (aparte de bevacizumab), inmunoterapia o terapia con fármacos experimentales administrada en el plazo de 5 semividas del fármaco o en las dos semanas antes del inicio del tratamiento del estudio, lo que sea más largo; tratamiento con bevacizumab en las 4 semanas previas al inicio del tratamiento del estudio
- Tratamiento hormonal para el cáncer de mama en las 2 semanas previas al inicio del tratamiento del estudio
- Cirugía mayor a criterio del investigador, realizada en las 4 semanas anteriores al inicio del tratamiento del estudio o intervención quirúrgica programada para llevarse a cabo dentro del periodo programado del estudio
- Tratamiento concomitante con agentes inmunosupresores o uso crónico de corticosteroides, con excepción de aplicaciones tópicas, los aerosoles nasales, los colirios o las inyecciones locales o pacientes que han recibido dosis bajas estables de corticosteroides durante al menos dos semanas antes de la inclusión en el estudio
- Infección crónica por hepatitis B (definida como la presencia de HBsAg y/o DNA de HBV), infección crónica por hepatitis C y/o ser portador conocido del HIV
- Prolongación del intervalo QTcF > 470 ms o prolongación del intervalo QT que el investigador considera clínicamente relevante
- Enfermedad que en opinión del investigador sea rápidamente progresiva o potencialmente mortal como afectación visceral extensa y sintomática, incluidas afectación hepática y diseminación pulmonar linfangítica del tumor
- Antecedentes de metástasis cerebral u otras metástasis del SNC
- Carcinomatosis linfangítica bilateral difusa
- Hipopotasemia de grado > 1
- Antecedentes de otra neoplasia maligna primaria en 5 años, con la excepción de carcinoma in situ de cuello uterino, útero, carcinoma basocelular o epidermoide o cáncer de piel no melanoma, tratados correctamente
- Antecedentes familiares de síndrome de QT largo
- Cualquier alteración de un sistema orgánico o enfermedad grave concomitante que, en opinión del investigador, afectaría a la seguridad del paciente o interferiría en la evaluación de la seguridad y la actividad antitumoral de los fármacos del estudio
- Pacientes que reciban tratamiento con fármacos que son inhibidores potentes o moderados de CYP3A4 y/o la glucoproteína P (PgP) y/o inductores potentes de CYP3A4 durante las 2 semanas previas a la inclusión en el estudio
- Pacientes que hayan recibido más de dos líneas de quimioterapia para el cáncer de mama localmente avanzado o metastásico (Para la Fase II, más de una línea)

E.5 End points

E.5.1

Primary end point(s)

1: Progression-free survival (PFS)

2: occurrence of Dose Limiting Toxicity (DLT) - phase I part

1: Supervivencia libre de progresión

2: Aparición de toxicidad limitante de la dosis - fase I

E.5.1.1

Timepoint(s) of evaluation of this end point

1: up to 10,8 months

2: up to 28 days

1: hasta 10,8 meses

2: hasta 28 días

E.5.2

Secondary end point(s)

1: Time to progression (TTP), defined as the duration of time from the date of C1V1 until the date of the first objective tumor progression

2: Objective response (OR), defined as complete response (CR) or partial response (PR) (CR + PR)

3: Time to objective response

4: Duration of objective response

5: Clinical benefit (CB), defined as best overall response of complete response (CR) or partial response (PR), or stable disease (SD) >=6 months, or Non-CR/Non-PD for >=6 months (CR + PR + SD6m + Non-CR/Non-PD6m)

6: Duration of clinical benefit

1: El tiempo hasta la progresión (TTP) se define como el tiempo transcurrido desde la fecha de la C1V1 hasta la fecha de la primera progresión tumoral objetiva
2: La respuesta objetiva (OR), definida como respuesta completa (CR) o respuesta parcial (PR) (CR + PR)
3: Tiempo hasta la respuesta objetiva
4: Duración de la respuesta objetiva
5: El beneficio clínico (CB) se define como la mejor respuesta global de respuesta completa (CR) o respuesta parcial (PR), o enfermedad estable (SD) ? 6 meses, o ni CR/ni PD durante ? 6 meses (CR+PR+SD6m+ni CR/ni PD6m)
6: Duración del beneficio clínico

E.5.2.1

Timepoint(s) of evaluation of this end point

1: up to 10,8 months

2: up to 10,8 months

3: up to 10,8 months

4: up to 10,8 months

5: up to 10,8 months

6: up to 10,8 months

1: hasta 10,8 meses

2: hasta 10,8 meses

3: hasta 10,8 meses

4: hasta 10,8 meses

5: hasta 10,8 meses

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

Yes

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

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

Belgium

France

Ireland

Netherlands

Sweden

Korea, Republic of

Spain

Taiwan

United Kingdom

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

LVLS

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:

135

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

170

F.4.2.2

In the whole clinical trial

226

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)

any anti cancer therapy at investigators discretion

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

2014-04-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-12-14

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