Clinical Trials Register

Summary
EudraCT Number:	2016-002333-29
Sponsor's Protocol Code Number:	GEMCAD-1601
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2017-02-23
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

2016-002333-29

A.3

Full title of the trial

Preoperative induction therapy with 12 weeks of Panitumumab in combination with mFOLFOX-6 in an enriched population (Quadruple Wild-Type) of patients with mrT3 rectal cancer of the middle third with clear mesorectal fascia

Tratamiento preoperatorio de inducción con 12 semanas de Panitumumab combinado con FOLFOX 6m en una población enriquecida (Quádruple Wild-Type) de pacientes con cáncer de recto de tercio medio mrT3 y fascia mesorrectal no invadida

A.3.1

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

Preoperative treatment with chemotherapy and a drug called panitumumab, without radiation, to assess the decrease or disappearance of rectal adenocarcinoma diagnosed

Tratamiento preoperatorio con quimioterapia y un fármaco denominado panitumumab, sin radioterapia, para valorar la disminución o desaparición del tumor del recto diagnosticado

A.3.2

Name or abbreviated title of the trial where available

PIER STUDY

ESTUDIO PIER

A.4.1

Sponsor's protocol code number

GEMCAD-1601

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	GEMCAD (Grupo Español Multidisciplinar en Cáncer Digestivo)
B.1.3.4	Country	Spain
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	AMGEN, 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	PIVOTAL, S.L.
B.5.2	Functional name of contact point	Myriam García Iglesias
B.5.3	Address:
B.5.3.1	Street Address	C/ Gobelas, 19, La Florida
B.5.3.2	Town/ city	MADRID
B.5.3.3	Post code	28023
B.5.3.4	Country	Spain
B.5.4	Telephone number	34917081250
B.5.5	Fax number	34917081301
B.5.6	E-mail	myriam.garcia@pivotal.es

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	Yes
D.2.1.1.1	Trade name	VECTIBIX
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN EUROPE B.V
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
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	Panitumumab is an anti-EGFR humanized IgG2 monoclonal antibody generated from transgenic mice engineered to express human immunoglobulin IgG2 genes (XenoMouse).

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 rectal adenocarcinoma of intermediate risk (defined by magnetic resonance imaging [MRI]), without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for preoperative treatment.

Pacientes con un adenocarcinoma de recto de riesgo intermedio (definido mediante resonancia magnética [RNM]) con ausencia de mutaciones en KRAS, BRAF, NRAS y Pi3KCA, que son candidatos a un tratamiento preoperatorio.

E.1.1.1

Medical condition in easily understood language

Rectal adenocarcinoma of intermediate risk (defined by magnetic resonance imaging) without mutations in KRAS, BRAF, NRAS and PI3KCA, who are candidates for preoperative treatment.

Adenocarcinoma de recto de riesgo intermedio (definido mediante resonancia magnética) con ausencia de mutaciones en KRAS, BRAF, NRAS y Pi3KCA, que son candidatos a un tratamiento preoperatorio.

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	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10010029
E.1.2	Term	Colorectal cancer NOS
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

Evaluate the efficacy of induction therapy with mFOLFOX-6 and panitumumab in a screened population of patients with rectal adenocarcinoma of intermediate risk with quadruple wild-type genes in terms of pathologic complete response (pCR)

Evaluar la eficacia del tratamiento de inducción con mFOLFOX 6m y panitmumab en una población seleccionada de pacientes con adenocarcinoma de recto de riesgo intermedio, quádruple wild-type, en términos de respuesta completa patológica (RCp)

E.2.2

Secondary objectives of the trial

● Evaluate the pathologic parameters predictive of efficacy: R0 resection, tumor regression grade (TRG), understaging (mrT vs. ypT)
● R0 resection rate, unaffected circumferential resection margin rate.
● Safety and tolerability of treatment with mFOLFOX-6 + panitumumab.
● Determine the rate of surgical complications at 30 days.
● Evaluate local recurrence and disease-free survival (PFS) at 2 years.
● Evaluate overall survival.
● Plasma biomarker study with studies of DNA, RNA and protein expression for the determination of prognostic and response-predictive biomarkers.
● Radiological study: Correlation between clinical complete response (as measured by diffusion-weighted MRI plus endoscopy) and pathologic complete response

● Evaluar los parámetros de eficacia anatomopatológicos: resección R0, grado de regresión del tumor (GRT), infraestadificacion (mrT vs. ypT)
● Tasa de resección R0, Tasa de margen circunferencial no afecto
● Seguridad y tolerabilidad del tratamiento con FOLFOX 6m + panitumumab.
● Determinar la tasa de complicaciones quirúrgicas a 30 días.
● Evaluar la recurrencia local y la supervivencia libre de enfermedad (ILE) a 2 años.
● Evaluar la supervivencia global.
● Estudio de biomarcadores en plasma, con la realización de estudios en DNA, RNA y expresión de proteínas para la determinación de biomarcadores pronósticos y predictivos de respuesta.
● Estudio radiológico: Correlación entre respuesta completa clínica (evaluada con Resonancia magnética con difusión más endoscopia) y respuesta completa patológica

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

● Molecular objectives: Optional plasma biomarker study with studies of DNA, RNA and protein expression for the determination of prognostic and response-predictive biomarkers.
● Radiological study: Correlation between clinical complete response (as measured by diffusion-weighted MRI plus endoscopy) and pathologic complete response.

● Objetivos moleculares: Subestudio opcional de biomarcadores en plasma, con la realización de estudios en DNA, RNA y expresión de proteínas para la determinación de biomarcadores pronósticos y predictivos de respuesta.
● Estudio radiológico: Correlación entre respuesta completa clínica (evaluada con Resonancia magnética con difusión más endoscopia) y respuesta completa patológica

E.3

Principal inclusion criteria

1) Signed and dated informed consent form, and willingness and ability to comply with the requirements of the protocol;
2) Men or women with rectal cancer, age ≥ 18 and <75 years;
3) Histologically documented adenocarcinoma of the rectum. All other histologic types are excluded. A minimum of 4 biopsies of the rectal primary tumor must be available, with tumor representation > 50% in each sample. The samples will be sent to Val d’Hebron Institute of Oncology (VHIO) for molecular determination. The 4 blocks of the 4 biopsies will be sent included in paraffin.
4) Rectal cancer candidate for R0 resection with preservation of the rectal sphincter.
5) Tumors with the following characteristics on high-resolution thin-slice (3 mm) MRI:
● mrT3
● Tumors of the middle third, defined as tumors with an inferior margin ≤ 12 cm from the anal verge, and above the plane of the elevators (insertion of the elevators).
● Absence of MRF invasion, defined as a distance ≥ 1 mm between the tumor and the fascia;
6) Absence of mutations in KRAS (mutations in KRAS exon 2 [codons 12/13], exon 3 [codons 59/61] and exon 4 [codon 117/146], NRAS (NRAS exon 2 [codons 12/13], exon 3 [codons 59/61] and exon 4 [codons 117/146]), BRAF (exon 15 [codon 600] and PI3KCA in exons 9 and 20
7) ECOG performance status ≤ 2;
8) Hematological status:
- Neutrophils (ANC) ≥ 1.5 x 109/L;
- Platelets ≥ 100 x 109/L;
- Hemoglobin ≥ 9 g/dL;
9) Adequate renal function: serum creatinine <1.5 x upper limit of normal (ULN);
10) Adequate liver function:
- Serum bilirubin ≤ 1.5 x ULN,
- Alkaline phosphatase < 5 x ULN,
- AST/ALT < 3 x ULN;
11) Regular monitoring feasible;
12) In women of childbearing potential, a negative serum pregnancy test within 1 week (7 days) before the start of study treatment;
13) Women must commit to using reliable and appropriate methods of contraception for up to at least three months after the end of the study treatment (when applicable). Men with a partner of childbearing potential must agree to use a method of contraception and their partners must use another contraceptive method for the duration of the trial.

1) Consentimiento informado firmado y datado, y dispuestos a cumplir con las exigencias del protocolo y con capacidad de hacerlo;
2) Varones o mujeres con cáncer rectal, de edad ≥ 18 y < 75 años;
3) Adenocarcinoma de recto documentado histológicamente. Se excluyen todos los demás tipos histológicos; Se debe disponer de un mínimo de 4 biopsias del tumor primario rectal con una representación tumoral >50% en cada muestra. Estas se deberán mandar al VHIO para su determinación molecular. Se mandarán los 4 bloques de las 4 biopsias en parafina.
4) Cáncer rectal candidato a resección R0 con preservación del esfínter rectal.
5) Tumor que cumpla las siguientes características en la RNM de alta resolución con cortes finos (3 mm):
● mrT3
● Tumores de tercio medio, definido como tumor cuyo borde inferior esté ≤ 12 cm del margen anal y por encima del plano de los elevadores (origen de los elevadores).
● Ausencia de invasión de la FMR, definido como una distancia ≥ 1 mm entre el tumor y la fascia;
6) Ausencia de mutación en KRAS (Mutaciones in KRAS exon 2 (condones 12/13), exon 3 (codones 59/61) and exon 4 (codones 117/146), NRAS (NRAS exon 2 (codones 12/13), exon 3 (codones 59/61) and exon 4 (codones 117/146)), BRAF (exon 15 (codon 600) y PI3KCA en exon 9 y 20
7) Capacidad funcional según la clasificación ECOG de ≤ 2;
8) Estado hematológico:
- Neutrófilos (RAN) ≥ 1,5 x 109/L;
- Plaquetas ≥ 100 x 109/L;
- Hemoglobina ≥ 9 g/dL;
9) Función renal adecuada: nivel de creatinina sérica < 1,5 x límite superior de la normalidad (LSN);
10) Función hepática adecuada:
- Niveles séricos de bilirrubina ≤ 1,5 x LSN,
- Fosfatasa alcalina < 5 x LSN,
- AST/ALT < 3 x LSN;
11) Seguimiento regular viable;
12) En las mujeres con potencial fértil, una prueba de embarazo negativa mediante análisis de suero en el plazo de 1 semana (7 días) antes del inicio del tratamiento en estudio;
13) Las mujeres deben comprometerse a utilizar métodos de anticoncepción fiables y apropiados hasta al menos tres meses después del final del tratamiento en estudio (cuando ello sea aplicable). Los varones con una pareja con potencial fértil deben aceptar utilizar un método de anticoncepción además de que su pareja utilice otro método anticonceptivo durante la realización del ensayo.

E.4

Principal exclusion criteria

1. Mucinous adenocarcinoma.
2. N2 lymph node involvement, defined as: 4 or more lymph nodes in the mesorectum showing morphological signs of metastatic involvement on MRI. A lymph node is considered malignant when:
a. Short axis > 9 mm.
b. Short axis 5-9 mm and ≥2 of the following criteria.
I. Rounded appearance.
ii. Heterogeneous margin.
iii. Heterogeneous signal intensity.
c. Axis < 5 mm AND round shape AND heterogeneous margin AND heterogeneous signal intensity.
3. Extramesorectal lymph node involvement: an involved extramesorectal lymph node is defined as a lymph node in the obturator area with a short axis > 10 mm, round shape and heterogeneous signal.
4. Prior treatment with panitumumab or cetuximab;
5. Pre-existing permanent neuropathy (grade ≥ 2 NCI-CTCAE);
6. Concomitant antitumor treatment not foreseen in the protocol (e.g., chemotherapy, targeted molecular therapy, immunotherapy);
7. Treatment with any other investigational medicinal product within the 28 days prior to study entry;
8. Other simultaneous or prior malignancy, except: i) properly treated uterine cervix carcinoma in situ, ii) basal or squamous cell skin carcinoma, iii) cancer in complete remission for a period > 5 years;
9. Evidence of metastatic disease additional studies of the physical examination;
10. Any other severe and uncontrolled non-malignant disease, major surgery or traumatic injury in the last 28 days;
11. Pregnant or breastfeeding women;
12. Patients with known allergy to any excipient of the investigational products;
13. Clinically significant cardiovascular disease, including myocardial infarction, unstable angina, symptomatic congestive heart failure or cardiac arrhythmia in the year before randomization in the study.
14. Intestinal occlusion: In the case of intestinal occlusion, patients may be enrolled in the study after performing a derivative stoma.
15. Interstitial Lung Disease.

1. Adenocarcinoma mucinoso.
2. Afectación ganglionar N2, definido como: 4 o más ganglios en el mesorrecto mostrando signos morfológicos en la RM de afectación metastásica: Un ganglio es considerado maligno cuando:
a. Eje corto >9mm
b. Eje corto 5-9mm y ≥2 de los siguientes criterios
i. Apariencia redondeada
ii. Borde heterogéneo
iii. Intensidad de señal heterogénea
c. Eje <5mm Y apariencia redondeada Y borde heterogéneo E intensidad de señal heterogénea
3. Afectación ganglionar extramesorrectal: Un ganglio extramesorrectal afectado se define como un ganglio en las areas del obturador con un diámetro corto > 10 mms, forma redondeada y señal heterogénea.
4. Tratamiento previo con panitumumab o cetuximab;
5. Neuropatía permanente preexistente (grado ≥ 2 de los NCI);
6. Tratamiento antitumoral concomitante no planificado en el protocolo (por ejemplo, quimioterapia, tratamiento molecular dirigido a diana, inmunoterapia);
7. Tratamiento con cualquier otro producto farmacológico en investigación en un plazo de 28 días antes de la inclusión en el estudio;
8. Otra enfermedad maligna simultánea o previa, excepto: i/ carcinoma de cuello uterino in situ adecuadamente tratado, ii/ carcinoma basocelular o espinocelular de la piel, iii/ cáncer en remisión completa durante un periodo > 5 años;
9. Evidencia de enfermedad metastásica en las exploraciones complementarias o en la exploración física;
10. Cualquier otra enfermedad no maligna grave y no controlada, intervención de cirugía mayor o lesión traumática en los últimos 28 días;
11. Mujeres embarazadas o en fase de lactancia natural;
12. Pacientes con alergia conocida a cualquier excipiente de los fármacos en estudio;
13. Enfermedad cardiovascular clínicamente significativa, incluyendo infarto de miocardio, angina inestable, insuficiencia cardiaca congestiva sintomática o arritmia cardiaca un año antes de la randomización en el estudio.
14. Oclusión intestinal: En el caso de oclusión intestinal, los pacientes serán incluibles en el estudio tras la realización de un estoma derivativo.
15. Enfermedad pulmonar intersticial.

E.5 End points

E.5.1

Primary end point(s)

Analyze the number of patients achieving pCR after induction treatment with mFOLFOX-6 + panitumumab. Pathologic CR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes (ypT0N0).

Analizar el número de pacientes que alcanzan una RCp después del tratamiento de inducción con FOLFOX 6m + panitumumab. La RCp se definirá como la ausencia de células tumorales viables en el tumor primario y en los ganglios linfáticos (ypT0N0).

E.5.1.1

Timepoint(s) of evaluation of this end point

Stage 1 - 18 patients will be enrolled:
- If the number of responses is less than or equal to 3, the trial will be closed prematurely and it will be concluded that the treatment is not sufficiently active to merit continuing the study.
- If the number of responses is at least 4, 24 more evaluable patients will be enrolled, for a total of 42 evaluable patients.

Stage 2 - The second analysis will be carried out when there are 42 patients evaluable for response:
- If the number of responses is less than or equal to 9, the conclusion of the study will be that the treatment did not achieve the optimum value set.
- If instead the number of responses is at least 10, it will be assumed that the treatment might be active enough to continue with further studies.

1ª Etapa - Se incluirán 18 pacientes:
- Si el número de respuestas es menor que o igual a 3, el ensayo se cerrará prematuramente y la conclusión será que el tratamiento no es suficientemente activo como para continuar el estudio.
- Si el número de respuestas es al menos de 4, se incluirán 24 pacientes evaluables más hasta un total de 42 pacientes evaluables.

2ª Etapa - El segundo análisis se llevará a cabo cuando haya 42 pacientes evaluables para respuesta:
- Si el número de respuestas es menor que o igual a 9, la conclusión del estudio será que el tratamiento no ha alcanzado el valor óptimo previsto.
- Si por el contrario el número de respuestas es de al menos 10, se asume que el tratamiento podría ser suficientemente activo como para continuar con estudios posteriores.

E.5.2

Secondary end point(s)

● Determine the rates of R0 resection and free mesorectal fascia (or circumferential margin)
● Evaluation of TRG; the residual tumor after preoperative treatment is evaluated semi-quantitatively using the 5-point regression grading scale established by Dworak
● Evaluate the rate of tumor understaging (mrT versus ypT)
● Evaluate the quality of surgery (according to the histopathology report)
● The safety and tolerability of study treatment will be assessed by adverse events (AEs) and changes in laboratory results. The adverse events will be encoded using the Medical Dictionary for Regulatory Activities (MedDRA), version 18.1 or later, and evaluated using the U.S. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
● The surgical complications will be evaluated by means of the AEs reported over 30 days after surgery.
● Determine the rate of local recurrence, distant metastasis rate, disease-free survival and overall survival at 3 years.

● Determinar las tasas de resección R0 y la tasa de fascia mesorrectal libre (o margen circunferencial)
● Evaluación del GRT; el tumor residual después del tratamiento preoperatorio se evaluará de forma semicuantitativa según la escala de gradación de la regresión de 5 puntos establecida por Dvorak
● Evaluar la tasa de infraestadificación del T (mrT versus ypT)
● Evaluar la calidad de la cirugía (según informe AP)
● La seguridad y la tolerabilidad del tratamiento en estudio se evaluarán mediante los acontecimientos adversos (AA) y las modificaciones de datos de análisis de laboratorio. Los AA se codificarán mediante el Medical Dictionary for Regulatory Activities [MedDRA] versión 18.1 o posterior y se evaluarán con el empleo de los criterios de toxicidad Common Terminology Criteria for Adverse Events del National Cancer Institute (NCI-CTCAE) versión 4.0.
● Se evaluarán las complicaciones quirúrgicas mediante los AA notificados a lo largo de 30 días después de la intervención quirúrgica.
● Determinar la tasa de recurrencias locales, tasa de metástasis a distancia, el intervalo libre de progresión, y supervivencia global a los 3 años.

E.5.2.1

Timepoint(s) of evaluation of this end point

Two years after last patient enrollment

Dos años después de la inclusión del último paciente

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

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)

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

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

Yes

E.8.1.7.1

Other trial design description

Ensayo de un solo brazo

Single-arm trial

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

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

24 months from enrollment of the last patient in the trial

24 meses desde la inclusión del último paciente en el ensayo

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:

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

In such case the consent could be given by some witness (patient relatives or friends) or legal representative

En tal caso, el consentimiento puede ser dado por algún testigo (familiares o amigos del paciente) o representante legal

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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

Ninguno

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	AMGEN S.A.
G.4.3.4	Network Country	Spain
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	ACTUALMED - JAUME I UNIVERSITY
G.4.3.4	Network Country	Spain

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-04-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-07

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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