Clinical Trials Register

Summary
EudraCT Number:	2015-005464-42
Sponsor's Protocol Code Number:	2335/2015
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-07-04
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

Spain - AEMPS

A.2

EudraCT number

2015-005464-42

A.3

Full title of the trial

A phase II study to assess the efficacy of the anti-PD-L1 antibody atezolizumab (MPDL3280A) administered with stereotactic ablative radiotherapy (SABR) in patients with metastatic tumours

Ensayo clínico fase II para evaluar la eficacia del anticuerpo anti-PD-L1 atezolizumab (MPDL3280A) administrado con radioterapia ablativa estereotáctica (SABR) en pacientes con tumores metastásicos

A.3.1

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

A phase II study to assess the efficacy of the antibody atezolizumab administered with stereotactic ablative radiotherapy in patients with metastatic cancer

Ensayo clínico en fase II que pretende evaluar la eficacia del anticuerpo atezolizumab cuando se administra con radioterapia ablativa estereotáctica en pacientes que presentan cáncer metastásico

A.3.2

Name or abbreviated title of the trial where available

SABR-PDL1

A.4.1

Sponsor's protocol code number

2335/2015

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	Gustave Roussy
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	ROCHE
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	Gustave Roussy
B.5.2	Functional name of contact point	Regulatory affairs officer
B.5.3	Address:
B.5.3.1	Street Address	114, rue Edouard Vaillant
B.5.3.2	Town/ city	Villejuif
B.5.3.3	Post code	94805
B.5.3.4	Country	France
B.5.4	Telephone number	+33142116198
B.5.5	Fax number	+33142116290
B.5.6	E-mail	SPEC.Affaires.reglementaires@gustaveroussy.fr

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	atezolizumab
D.3.2	Product code	MPDL3280A
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	ATEZOLIZUMAB
D.3.9.3	Other descriptive name	MPDL3280A
D.3.9.4	EV Substance Code	SUB126162
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	60
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	Yes
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

Patients with one of following metastatic tumours:
- Metastatic colorectal cancer
- Metastatic non-small lung cancer
- Metastatic renal cell carcinoma

Pacientes con uno de los siguientes tumores metastásicos
- Cáncer colorrectal metastásico
- Cáncer de pulmón de células no pequeñas metastásico
- Cáncer renal metastásico

E.1.1.1

Medical condition in easily understood language

- Metastatic colorectal cancer
- Metastatic non-small lung cancer
- Metastatic renal cell carcinoma

- Cáncer colorrectal metastásico
- Cáncer de pulmón de células no pequeñas metastásico
- Cáncer renal metastásico

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10050513
E.1.2	Term	Metastatic renal cell carcinoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
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.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10052362
E.1.2	Term	Metastatic colorectal cancer
E.1.2	System Organ Class	100000016864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Determine, in each cohort, the 1 year PFS rate (based on RECIST v1.1.) under combined SABR and anti-PDL1 atezolizumab therapy

Determinar, en cada cohorte, la tasa de supervivencia libre de progresión al cabo de un año recibiendo terapia combinada de SABR más el inhibidor de PDL1, atezolizumab, conforme a los criterios RECIST v1.1.

E.2.2

Secondary objectives of the trial

1. Determine the PFS rate under combined SABR and anti-PDL1 atezolizumab therapy

2. Further describe, the efficacy of combination (SABR and atezolizumab) both on the irradiated lesions and the non-irradiated lesions based on tumour response indicators and clinical endpoints

3. Determine the Treatment failure rate

4. Evaluate the toxicity of atezolizumab in combination with SABR

1. Determinar la tasa de supervivencia libre de progresión (SLP) recibiendo
terapia combinada de SABR más el inhibidor de PDL1, atezolizumab.
2. Describir la eficacia de la terapia combinada tanto en las lesiones irradiadas
como en las no irradiadas según los indicadores de respuesta tumoral y los
criterios de valoración clínica establecidos.
3. Determinar la tasa de fracaso del tratamiento.
4. Evaluar la toxicidad de atezolizumab combinado con SABR.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients must be 18 years of age or older.
2. Histologically or cytologically proven metastatic solid tumours including: colorectal (CRC, Microsatellite instability negative and positive) in treatment failure as per the current standard recommendation ; non-small cell lung cancer (NSCLC) pretreated by at least one line chemotherapy by platinum salt. Patients EGFR mutant can be included only if they have been treated with, or developed toxicity with or refused to be treated with anti-EGFR therapy ; renal cell carcinoma (RCC) pretreated by at least one line therapy by a tyrosin kinase inhibitor.
3. Patients with at least: one measurable metastasis by RECIST 1.1 eligible for SABR in terms of dose constraints at organ at risk and ≤ 4 cm; and one not treated measurable metastasis by RECIST 1.1. If all tumour sites
are accessible to SABR, one of them will not be treated.
4.Evaluation by a radiation oncologist within 45 days prior to study registration, including imaging workup to document metastases
5. The irradiated and unirradiated tumour sites must be accessible to tumour biopsy (additional written consent required)
6. Patients may not have used any systemic anticancer treatment (approved or investigational agent) within 4 weeks prior to cycle 1 day 1
7. Life expectancy of more than 3 months
8. Patients must have adequate organ function
9. Patients must be affiliated to a social security system

1. Los pacientes deberán ser mayores de 18 años.
2. Tumores sólidos con confirmación citológica o histológica de metástasis:
colorrectal (CCR, inestabilidad microsatélite negativa y positiva) en
fracaso terapéutico según los criterios estándares actuales; carcinoma pulmonar no microcítico (NSCLC) tratado previamente con
al menos una línea de quimioterapia con sal de platino. Solo se podrá
incluir a los pacientes con mutaciones en el gen EGFR si ya han
recibido terapia con inhibidores de EGFR, han desarrollado toxicidad
por los mismos, o se han negado a ser tratados con ellos; carcinoma de células renales tratado previamente con al menos una línea de terapia con un inhibidor de la quinasa tirosina.
3. Los pacientes con al menos: una metástasis evaluable con los criterios RECIST 1.1 elegible para SABR en términos de limitaciones de dosis en el órgano en riesgo y ≤ 4 cm; y una metástasis no tratada evaluable mediante los criterios RECIST 1.1. En caso de que se pueda acceder a todos los sitios tumorales con la SABR, uno de ellos quedará sin tratar.
4. Evaluación por un oncólogo de radioterapia en un plazo de 45 días previos a
la inclusión del paciente en el estudio, incluyendo la obtención de imágenes
para documentar las metástasis.
5. Los tumores irradiados y no irradiados deberán ser accesibles para la
obtención de biopsias tumorales, para lo cual se requerirá otro consentimiento
informado.
6.Los pacientes no deberán haber recibido ningún tratamiento oncológico
sistémico (con agentes aprobados o experimentales) en las 4 semanas
anteriores al ciclo 1, día 1.
7.Una esperanza de vida superior a los 3 meses.
8.Los pacientes deberán presentar una función orgánica adecuada.
9.Los pacientes deberán estar cubiertos por la seguridad social.

E.4

Principal exclusion criteria

1. Metastases located to the brain and with clinical signs and/or leptomingeal carcinomatosis, or with indistinct borders making targeting not feasible
2. Metastasis localized to the central part of the chest and requiring irradiation
3. Irradiation by SABR should not include metastases located within 3 cm of the previously irradiated structures:
* Spinal cord previously irradiated to > 40 Gy
* Brachial plexus previously irradiated to > 50 Gy
* Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
* Brainstem previously irradiated to > 50 Gy
* Lung previously irradiated with prior V20Gy > 30%
4. Irradiation required for cord compression and for superior veina cava syndrome.
5. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti−PD1, or anti−PDL1 therapeutic antibodies
Patients who have received prior treatment with anti−CTLA-4 may be enrolled, provided at least 5 half-lives (approximately 75 days) have elapsed from the last dose of anti-CTLA-4 to the first dose of atezolizumab and there was no history of severe immune-mediated adverse effects from anti−CTLA-4 (NCI CTCAE Grade 3 and 4)
6. Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1
7. Active or History of autoimmune or inflammatory disease
Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
Patients with vitiligo or psoriasis or grave’s disease, not requiring systemic treatment within the last 2 years, are eligible
8. Any malignancy other than the disease under study in the past 5 years excepting skin cancers such as BCC or SCC
9. Uncontrolled tumour-related pain.
Patients requiring pain medication must be on a stable regimen at study entry.
Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
11. Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
Patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible. However, patients who are receiving denosumab prior to enrollment must be eligible to receive bisphosphonate instead and willing to switch to bisphosphonate therapy while on the study.
12. Severe active co-morbidity as defined in the protocol

1. Metástasis localizadas en el cerebro y con signos clínicos y/o carcinomatosis
leptomeníngea, o con bordes mal delimitados que imposibilitan la focalización.
2. Metástasis localizada en la parte central del tórax que requiera irradiación.
3. En la irradiación con SABR no se incluirán las metástasis localizadas a menos
de 3 cm de estructuras irradiadas con anterioridad:
- Médula espinal irradiada previamente a > 40 Gy
- Plexo braquial previamente irradiado a> 50 Gy
- Intestino delgado, intestino grueso o estómago previamente irradiado a> 45 Gy
- Tronco cerebral previamente irradiado a> 50 Gy
- Pulmón previamente irradiado con V20Gy > 30%
4. Necesidad de irradiación por compresión de la médula y síndrome de la vena
cava superior.
5. Tratamiento anterior con agonistas de CD137 o terapias de bloqueo de control
de inmunidad (checkpoint blockade therapy), o inhibidores de PD1 o PDL1.
Se podrá incluir a los pacientes que hayan recibido tratamiento previo con inhibidores de CTLA-4, siempre que hayan transcurrido al menos 5 semividas
(aproximadamente 75 días) entre la última dosis del inhibidor de CTLA-4 y la
primera dosis de atezolizumab, y no existan antecedentes de reacciones
adversas inmunológicas graves causadas por el inhibidor de CTLA-4 (Grados
3 y 4 en la CTCAE del NCI ).
6. Tratamiento con agentes inmunoestimuladores sistémicos (incluidos, entre
otros, el interferón alfa (IFN-α) y la interleucina-2 (IL-2) en las últimas 4
semanas o cinco semividas del fármaco (lo que sea más corto) previas al Ciclo
1, Día 1.
7. Antecedentes de enfermedad inflamatoria autoinmune o enfermedad
inflamatoria autoinmune activa.
Serán elegibles los pacientes con antecedentes de hipotiroidismo autoinmune
en tratamiento estable con hormona tiroidea de sustitución.
Serán elegibles los pacientes con diabetes melitus tipo 1 en tratamiento
estable con insulina.
Serán elegibles los pacientes con vitiligo o psoriasis o enfermedad de Grave
que no hayan requerido tratamiento sistémico en los últimos 2 años.
8. Cualquier otra malignidad diferente a la enfermedad en estudio en los últimos
5 años, a excepción del cáncer de piel, como el carcinoma de células basales
(CBC) y el carcinoma de células escamosas (SCC).
9. Dolor no controlado relacionado con el tumor.
Los pacientes que requieran analgésicos deberán estar recibiendo un
tratamiento estable al inicio del estudio.
En su caso, deberá considerarse la administración de terapia loco-regional para las lesiones metastásicas asintomáticas cuyo crecimiento probablemente causará problemas funcionales o dolor no tratable (p.ej. metástasis epidural
que en ese momento no esté asociada a la compresión de la médula espinal),
con anterioridad a la inclusión en el estudio.
10. Derrame pleural incontrolado, derrame pericárdico o ascitis que requieran
procedimientos recurrentes de drenaje (una vez al mes o con mayor
frecuencia).
11. Hipercalcemia incontrolada (> 1,5 mmol / L de calcio ionizado o Ca> 12 mg /
dL o calcio sérico corregido> ULN), o hipercalcemia sintomática que requiera
el uso continuo de terapia con bisfosfonatos o denosumab.
Serán elegibles aquellos pacientes que reciban terapia con bisfosfonato o
denosumab para prevenir eventos óseos y que no tengan antecedentes de
hipercalcemia clínicamente significativa. No obstante, los pacientes a los que se esté suministrando denosumab con anterioridad al estudio deberán ser elegibles para recibir bisfosfonato en su lugar y estar dispuestos a cambiar a una terapia con bisfosfonato durante el estudio.
12. Comorbilidad grave activa tal como se define en el protocolo.

E.5 End points

E.5.1

Primary end point(s)

Proportion of patients alive and free of progression at 1 year. Progression is defined using RECIST 1.1. criteria, or death, whatever the cause of death, whichever occurs first.

Porcentaje de pacientes vivos y sin progresión de la enfermedad al cabo de un año. La progresión se determinará conforme a los criterios RECIST 1.1. o el fallecimiento (lo que se produzca primero), independientemente de la causa.

E.5.1.1

Timepoint(s) of evaluation of this end point

Tumor evaluation performed at baseline, week 4, week 7, week 13 and then every 12 weeks up to 1 year from treatment initiation or to disease progression, whichever occurs first.

Evaluación tumoral realizada al inicio, en la semana 4, en la semana 7, en la semana 13 y a partir de aquí cada 12 semanas hasta un año desde el inicio de tratamiento o progresión de la enfermedad, lo que ocurra antes.

E.5.2

Secondary end point(s)

1. Delay from treatment initiation to date of progression or death, whatever the cause of death, whichever occurs first. Using RECIST 1.1. criteria and mRECIST criteria.

2. Tumour response indicators and clinical endpoints, assessed according to RECIST v 1.1 and mRECIST are:
- Disease Control Rate (DCR)
- Objective Response Rate (ORR)R
- Duration of response (DOR)
- Time to progression of non-irradiated lesions is computed as the delay from enrollment to the first occurrence of progression outside of the irradiated field
- Time to progression of irradiated lesions is computed as the delay from enrollment to the first occurrence of progression of irradiated lesions;
- Evaluation of the local control, distant control.

3. Proportion of patients who cannot receive the planned irradiation dose or relative atezolizumab dose intensity below 75% of the initially targeted dose (i.e below 900 mg).

4. AE according to NCI- CTCAE V4.03 scale

1. Supervivencia libre de progresión (SLP), medida desde la fecha de inicio del
tratamiento hasta la fecha en la que se produzca la progresión o la muerte, lo que se produzca en primer lugar. Según los criterios RECIST v 1.1 y la versión modificada.
2. Los indicadores de respuesta tumoral y los criterios de evaluación clínica según
los criterios RECIST v 1.1 y la versión modificada son:
- Tasa de control de la enfermedad (TCE).
- Tasa de respuesta objetiva (RO).
- Duración de la respuesta.
- El tiempo de progresión en las lesiones no irradiadas será el tiempo transcurrido desde la inclusión en el estudio hasta la progresión de la enfermedad fuera del campo irradiado.
- El tiempo de progresión en las lesiones irradiadas será el tiempo transcurrido
desde la inclusión en el estudio hasta la progresión de la enfermedad en las
lesiones irradiadas.
- Evaluación del control local, control distal.
3. Porcentaje de pacientes que no pueden recibir la dosis de irradiación indicada o una intensidad relativa de dosis de atezolizumab por debajo del 75% de la dosis
inicialmente estimada (es decir, por debajo de los 900 mg).
4. Toxicidad : Escala CTCAE V4.03 del NCI.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Tumor evaluation performed at baseline, week 4, week 7, week 13 and then every 12 weeks up to 1 year after treatment discontinuation or disease progression, whichever occurs first.

2. At each treatment administration (every 3 weeks for atezolizumab and on week 4 for SABR)

4. All along the study

1. Evaluación tumoral realizada al inicio, en la semana 4, en la semana 7, en la semana 13 y a partir de aquí cada 12 semanas hasta un año desde el inicio de tratamiento o progresión de la enfermedad, lo que ocurra antes.
2. En cada administración de tratamiento (cada 3 semanas para atezolizumab y en la semana 4 para SABR).

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

E.6.7

Pharmacodynamic

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

E.8.1.1

Randomised

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)

E.8.2.2

Placebo

E.8.2.3

Other

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

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 the trial is defined as being the last protocol-specified visit of the last patient, i.e the last visit of the last patient during the follow-up period (up to 12 months after atezolizumab discontinuation) or the last attempt by the investigator to schedull this visit for the last patient.

El final del ensayo se define como la última visita específica de protocolo del último paciente, por ejemplo, la última visita del último paciente durante el periodo de seguimiento (hasta 12 meses tras la discontinuación del atezolizumab) o el último intento del investigador de programar esta visita para el último paciente.

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

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:

120

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

180

F.4.2.2

In the whole clinical trial

180

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

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

2017-11-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-10-27

P. End of Trial
P.	End of Trial Status	Ongoing

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