Clinical Trials Register

Summary
EudraCT Number:	2014-002063-14
Sponsor's Protocol Code Number:	GEMCAD-1402
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:	2014-08-06
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2014-002063-14

A.3

Full title of the trial

Induction FOLFOX with or without Aflibercept followed by chemoradiation in High Risk Locally Advanced Rectal Cancer. Phase II randomized, multicenter, open label trial

Tratamiento de inducción con FOLFOX con o sin Aflibercept seguido de quimio-radioterapia (QT/RT) en Carcinoma de de Recto localmente avanzado de Alto Riesgo. Ensayo abierto, Fase II, randomizado.

A.3.1

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

Induction FOLFOX with or without Aflibercept followed by chemoradiation in High Risk Locally Advanced Rectal Cancer. Phase II randomized, multicenter, open label trial

Tratamiento de inducción con FOLFOX con o sin Aflibercept seguido de quimio-radioterapia (QT/RT) en Carcinoma de de Recto localmente avanzado de Alto Riesgo. Ensayo abierto, Fase II, randomizado.

A.3.2

Name or abbreviated title of the trial where available

RIA Study

Estudio RIA

A.4.1

Sponsor's protocol code number

GEMCAD-1402

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	SANOFI-AVENTIS, 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	ZALTRAP
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS GROUPE
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	aflibercept
D.3.9.1	CAS number	862111-32-8
D.3.9.2	Current sponsor code	AVE0005
D.3.9.3	Other descriptive name	VEGF TRAP
D.3.9.4	EV Substance Code	SUB26987
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	4
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	Yes
D.3.11.13.1	Other medicinal product type	Fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in CHO K1 cells by recombinant DNA technology

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 high risk locally advanced rectal carcinoma (defined by Magnetic Resonance Imaging [MRI]), who are candidates for multimodality treatment.

Pacientes con alto riesgo de carcinoma de recto localmente avanzado definido por Resonancia Magnética Nuclear (RMN), candidatos a tratamiento multimodal.

E.1.1.1

Medical condition in easily understood language

Patients with high risk locally advanced rectal cancer (defined by Magnetic Resonance Imaging [MRI]), who are candidates for multimodality treatment.

Pacientes con alto riesgo de cáncer de recto localmente avanzado definido por Resonancia Magnética Nuclear (RMN), candidatos a tratamiento multimodal.

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	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10052362
E.1.2	Term	Metastatic colorectal cancer
E.1.2	System Organ Class	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

To evaluate the efficacy of induction therapy with mFOLFOX6 +/- aflibercept followed by CT/RT in terms of pathological Complete Responses (pCR)

Evaluar la eficacia del tratamiento de inducción con mFOLFOX6 +/- aflibercept seguido de QT/RT en términos de respuestas completas patológicas (RCp).

E.2.2

Secondary objectives of the trial

- To evaluate pathological parameters of efficacy: R0 resection, TRG, and positive or negative CRM rate.
- To evaluate the relationship between MRI changes with outcome.
- To further characterize the safety and tolerability of mFOLFOX6 +/- aflibercept followed chemoradiation.
- To determine the rate of 30 days surgical complications.
- To evaluate the 3 years local recurrence and DFS.
- To determine the levels of tumor biomarkers expression at baseline and correlate them with response to treatment with mFOLFOX6 + aflibercept.

- Evaluar parámetros patológicos de eficacia: resección R0, grado de regresión tumoral (TRG), y margen circunferencial radial (CRM) positivo o negativo.
- Evaluar la relación entre los cambios en RMN y las respuestas patológicas (mrTRG).
- Caracterizar la seguridad y tolerabilidad de mFOLFOX6 +/- aflibercept seguido de QT/RT.
- Determinar las complicaciones postquirúrgicas en los 30 días posteriores a la cirugía.
- Evaluar las recurrencias locales a los 3 años y la supervivencia libre de enfermedad.
- Determinar los niveles de expression de biomarcadores en basal, y correlacionarlos con la respuesta al tratamiento con mFOLFOX6 + aflibercept.

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

Substudy 'Markers of response' (v.1.6 12 June 2014)

Objective 1: To identify biomarkers of response to aflibercept

a) Evaluate the expression of markers in tumoral samples (from diagnosis biopsy and surgical specimen) and in serum (baseline and day +1) from rectal cancer patients treated with FOLFOX + aflibercept in the GEMCAD 1402 trial

b) Correlate the expression of markers with outcome (pathological response and survival)

Objective 2: To identify surrogate markers of response

a) Characterize the levels of markers in serum from rectal cancer patients treated with FOLFOX+aflibercept in the RIA trial

b) Correlate the changes in serum markers with response to treatment

Subestudio de 'Marcadores de respuesta' (v.1.6 12 de junio 2014)

Objetivo 1: Identificar biomarcadores de respuesta a aflibercept

a) Evaluar la expresión de marcadores en las muestras tumorales (a partir de la biopsia de diagnóstico y pieza quirúrgica) y en el suero (basal y día +1) de pacientes con cáncer de recto tratados con FOLFOX + aflibercept en el Ensayo GEMCAD-1402

b) Relacionar la expresión de marcadores con el resultado (respuesta patológica y supervivencia)

Objetivo 2: Identificar marcadores de respuesta

a) Caracterizar los niveles de los marcadores en el suero de pacientes con cáncer rectal tratados con FOLFOX + aflibercept en el ensayo RIA

b) Relacionar los cambios en los marcadores séricos con la respuesta al tratamiento

E.3

Principal inclusion criteria

1) Signed and dated informed consent, and willing and able to comply with protocol requirement;
2) Male or female subjects with rectal cancer ≥ 18 and <70 years of age;
3) High risk MRI-defined operable rectal cancer (with an inferior margin no more than 12 cm above the anal verge as assesed by MRI).
Presence of at least 1 of the following on high resolution, thin-slice MRI (3 mm):
Middle Third Tumors

-mrT3
a) Extramural vascular invasion (EMVI) positive
b) Extramural extension > 5 mms into perirectal fat
c) Mesorectal fascia (MRF) threatened or involved*

-mr T4***

Distal Third Tumors (?5 cm from anal verge)

- mrT3 tumor at or below levators
-T4 as above
N2**

*tumor or lymph node < 1 mm from the mesorectal fascia
**≥ 4 lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease. ≥ 4 nodes, whether enlarged or not, with a rounded, homogeneous appearance is thus not sufficient.
***T4a: overgrowth to an adjacent organ or structure or T4b: peritoneal involvement.
4) Histologically confirmed adenocarcinoma of the rectum. All other histological types are excluded;
5) ECOG Performance Status of ≤ 1;
6) Hematological status: neutrophils (ANC) ≥ 1.5x109/L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL;
7) Adequate renal function: serum creatinine level <1.5 x upper limit of normality (ULN);
8) Adequate liver function: serum bilirubin ≤ 1.5 x ULN, alkaline phosphatase <5xULN, AST/ALT < 3 x ULN;
9) Proteinuria <2+ (dipstick urinalysis) or ≤ 1g/24hour;
10) Regular follow-up feasible;
11) For female patients of childbearing potential, negative serum pregnancy test within 1 week (7 days) prior to starting study treatment;
12) Female patients must commit to using reliable and appropriate methods of contraception until at least three months after the end of study treatment (when applicable). Male patients with a partner of childbearing potential must agree to use contraception in addition to having their partner use another contraceptive method during the trial.

1) Que hayan fechado y firmado el consentimiento informado, y sean capaces de cumplir los requerimientos del protocolo;
2) Hombres o mujeres con cancer de recto y con edad ≥18 y <70 años;
3) Cáncer de recto operable de alto riesgo por RMN (con un margen inferior a no más de 12 cm del margen anal por RMN
Presencia de al menos una de las siguientes características en RMN de alta resolución y corte estrecho (3 mm):
Tumores del tercio medio:

-mrT3
a) Invasión vascular extramural (EMVI) positiva
b) Extensión extramural > 5 mm en grasa perirectal
c) Fascia mesorectal (MRF) amenazada o afecta*

-mr T4***

Tumores del tercio distal (≤5 cm del margen anal)

- Tumor mrT3, en o bajo los elevadores
-T4 como enumerado anteriormente

N2**

*tumor o ganglio linfático a < 1 mm de la fascia mesorectal
**≥4 ganglios linfáticos en el mesorecto con signos morfológicos en RMN indicando enfermedad metastásica. ≥4 ganglios linfáticos, aumentados o no de tamaño, con apariencia redondeada homogénea no es suficiente.
***T4a: crecimiento hacia un órgano o estructura adyacente o T4b: infiltración peritoneal.
4) Adenocarcinoma de recto confirmado histológicamente. El resto de tipos histológicos quedan excluidos;
5) ECOG Performance Status ≤1;
6) Requerimientos de hematología: neutrófilos (ANC) ≥1.5x109/L; plaquetas ≥100x109/L; hemoglobina ≥9g/dL;
7) Función renal adecuada: creatinina en suero <1.5 x límite superior de la normalidad (ULN);
8) Función hepática adecuada: bilirrubina sérica ≤1.5 x ULN, fosfatasa alcalina <5xULN, AST/ALT < 3 x ULN;
9) Proteinuria <2+ (dipstick) o ≤1g en orina de 24 horas;
10) Seguimiento regular factible;
11) En el caso de mujeres fértiles, test de embarazo negative en el plazo de una semana (7 días) antes de empezar el fármaco de estudio;
12) Las mujeres fértiles deben estar de acuerdo en usar métodos fiables y apropiados de contracepción al menos hasta tres meses después del fin de tratamiento (cuando sea aplicable). Los pacientes varones con pareja fértil deben estar de acuerdo en usar métodos contraceptivos adicionales a los que use su pareja durante el ensayo.

E.4

Principal exclusion criteria

1) Prior treatment with aflibercept;
2) History or evidence upon physical examination of metastasis;
3) Uncontrolled hypercalcemia;
4) Pre-existing permanent neuropathy (NCI grade ?2);
5) Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy;
6) Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy);
7) Treatment with any other investigational medicinal product within 28 days prior to study entry;
8) Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years;
9) Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 days;
10) Pregnant or breastfeeding women;
11) Patients with known allergy to any excipient to study drugs;
12) History of myocardial infarction and/or stroke within 6 months prior to randomization;
Previous history of stable angina, uncontrolled arrhythmia, and acute coronary syndrome even if controlled with medication or with myocardial infarction within the last 12 months.
13) Bowel obstruction.

1) Tratamiento previo con aflibercept;
2) Historia o evidencia a la exploración física de metastasis;
3) Hipercalcemia incontrolada;
4) Neuropatía permanente (grado NCI ≥2);
5) Hipertensión incontrolada (definida como presión arterial sistólica >150 mmHg y/o presión arterial diastólica >100 mmHg), o historia de crisis hipertensiva o encefalopatía hipertensiva;
6) Terapia antitumoral concomitante no planeada (quimioterapia, terapia dirigida, inmunoterapia);
7) Tratamiento con cualquier otro producto investigacional en los 28 días previos a la entrada en el estudio;
8) Otra neoplasia concomitante o previa, con excepción de: i/ carcinoma de cervix tratado adecuadamente, ii/ carcinoma cutáneo basocelular o escamoso, iii/ cáncer en remisión completa >5 años;
9) Cualquier otra enfermedad seria y no controlada, cirugía mayor o trauma en los 28 días previos;
10) Embarazo o lactancia;
11) Alergia a cualquier excipiente de los fármacos de estudio;
12) Historia de infarto de miocardio y/o ictus en los 6 meses previos a la randomización;
Historia previa de angina estable, arritmia incontrolada y síndrome coronario agudo, incluso estando controlados adecuadamente con medicación, o infarto de miocardio en los 12 meses previos.
13) Obstrucción intestinal.

E.5 End points

E.5.1

Primary end point(s)

To analyze the number of patients achieving pCR after induction therapy with mFOLFOX6 +/- aflibercept followed by CT/RT. pCR will be defined as the absence of viable tumor cells in the primary tumor and in the lymph nodes (ypT0N0)

Analizar el número de pacientes que alcancen RCp tras el tratamiento de inducción con mFOLFOX6 +/- aflibercept seguido de QT/RT. RCp se define como la ausencia de células tumorales viable en el tumor primario y en los ganglios linfáticos (ypT0N0).

E.5.1.1

Timepoint(s) of evaluation of this end point

Two interim analysis will be done to evaluate safety, futility/efficacy:

- At 33% of the sample size
- At 66% of the sample size

Final analysis will be done at 100% of the sample size (180 patients)

Se realizarán dos análisis intermedios para evaluar seguridad, futilidad/eficacia:

- Cuando se haya alcanzado el 33% del tamaño de la muestra
- Cuando se haya alcanzado el 66% del tamaño de la muestra

El análisis final se realizará cuando se haya alcanzado el 100% del tamaño de la muestra (180 pacientes)

E.5.2

Secondary end point(s)

- To determine CRM negative and R0 resection rates.
- TRG; residual tumor after preoperative therapy will be semiquantitatively evaluated according to the 5-point regression grading scale established by Mandard. Involvement of the histologic CRM will be defined as tumor ≤ 2 mm from the resection margin.
- T Downstaging: defined as a lower pathologic T stage compared to pre-treatment mrT stage
- The safety and tolerability of the study therapy will be assessed by means of AEs and changes in laboratory data. AEs will be coded and evaluated using the NCI-CTCAE v4.0 toxicity criteria (if NCI-CTCAE are not applicable, MedDRA will be used).
- Surgical complications will be assessed by means of AEs reported during 30 days post surgery.
- To determine the rate of local recurrence and DFS at 3-years.
- To determine the levels of tumor biomarkers expression at baseline in serum and biopsy and correlate them with MRI tumor regression and pathological response to treatment with mFOLFOX6 + aflibercept and relapse and survival outcomes

- Determinar el número de CRM negativos y resecciones R0.
- TRG; tumor residual tras tratamiento preoperatorio, sera evaluado semicuantitativamente de acuerdo a la escala de 5 puntos propuesta por Mandard. Se entenderá CRM afecto como la presencia de tumor a ≤ 2 mm del margen de resección.
- T Downstaging: definido como el menor estadio T patológico alcanzado comparado con el mrT pre-tratamiento.
- La seguridad y tolerabilidad del fármaco de estudio se determinará en función de los Acontecimientos Adversos (AEs) y cambios de laboratorio. Los AEs se codificarán usando el National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 toxicity criteria (si NCI-CTCAE no fuera applicable, se usaría el Medical Dictionary for Regulatory Activities [MedDRA]).
- Las complicaciones quirúrgicas se determinarán como AEs reportados durante los 30 días tras la cirugía.
- Determinar las recurrencias locales y la Supervivencia Libre de Enfermedad a 3 años.
- Determinar los niveles de biomarcadores en basal en suero y en la biopsia diagnóstica, y correlacionarlos con las respuestas patológicas a mFOLFOX6 + aflibercept y objetivos de recaída y supervivencia.

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

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 clinical study will end when the last recruited patient has concluded the follow-up period and completed the last follow-up visit. Any patient who terminate/discontinue the clinical study treatment earlier for any of the reasons listed in "Withdrawal, termination and interruption criteria" section (see protocol section 5.4) shall remain under follow-up for 3 years from randomization or until progression, except for patients who withdraw their informed consent, die or are lost to follow-up.

El Estudio terminará cuando el último paciente reclutado haya concluido completado la última visita de seguimiento. Cualquier paciente que termine/ discontinue el tratamiento del Ensayo antes por alguna de las razones enumeradas en la sección "Criterios de retirada, finalización e interrupción" (véase el punto 5.4 del protocolo) permanecerá en seguimiento 3 años desde la randomización o hasta la progresión, excepto los que hayan retirado su CI, mueran o se hayan perdido durante el seguimiento.

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

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:

180

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	PIVOTAL, S.L
G.4.3.4	Network Country	Spain
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	SANOFI ONCOLOGY, S.A
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

2014-10-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-02-04

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IMP with orphan designation in the indication
Orphan Designation Number:
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