Clinical Trials Register

Summary
EudraCT Number:	2015-003047-19
Sponsor's Protocol Code Number:	Sym004-09
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:	2016-02-03
Trial results	View results

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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2015-003047-19

A.3

Full title of the trial

An Open label, Multi-Center Phase 1b/2a Trial Investigating Different Doses of Sym004 in Combination with FOLFIRI in Patients with Metastatic Colorectal Cancer Progressing after First-Line Therapy

Ensayo multicéntrico, abierto, en fase Ib/IIa en el que se investigan distintas dosis de Sym004 combinadas con FOLFIRI en pacientes con cáncer colorrectal con metástasis en progresión tras el tratamiento de primera línea

A.3.1

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

Sym004 in Combitation with FOLFIRI (chemotherapy regimen) in metastatic colorectal cancer

Sym004 en combinación con FOLFIRI (regimen de quimioterapia) en cáncer colorrectal metastasico

A.4.1

Sponsor's protocol code number

Sym004-09

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	Symphogen A/S
B.1.3.4	Country	Denmark
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	Symphogen A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Symphogen A/S
B.5.2	Functional name of contact point	Ivan Horak
B.5.3	Address:
B.5.3.1	Street Address	Pederstrupvej 93
B.5.3.2	Town/ city	Ballerup
B.5.3.3	Post code	2750
B.5.3.4	Country	Denmark
B.5.4	Telephone number	4520552604
B.5.6	E-mail	idh@symphogen.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Sym004
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	Futuximab
D.3.9.1	CAS number	1310460-85-5
D.3.9.2	Current sponsor code	992 DS
D.3.9.3	Other descriptive name	Chimeric IgG anti-EGFR mAb (992)
D.3.9.4	EV Substance Code	SUB177082
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	9 to 18
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Modotuximab
D.3.9.1	CAS number	1310460-86-6
D.3.9.2	Current sponsor code	1024 DS
D.3.9.3	Other descriptive name	Chimeric IgG anti-EGFR mAb (1024)
D.3.9.4	EV Substance Code	SUB177082
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	9 to 18
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	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
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	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	IRINOTECAN
D.3.9.1	CAS number	97682-44-5
D.3.9.2	Current sponsor code	Irinotecan
D.3.9.4	EV Substance Code	SUB08295MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
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	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.2.1.2	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	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	Folinic acid
D.3.9.1	CAS number	1492-18-8
D.3.9.2	Current sponsor code	Folinic Acid (FA)
D.3.9.3	Other descriptive name	FOLINIC ACID
D.3.9.4	EV Substance Code	SUB13910MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
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: 4
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.2.1.2	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	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	Fluorouracil
D.3.9.1	CAS number	51-21-8
D.3.9.2	Current sponsor code	5-Fluorouracil (5-FU)
D.3.9.3	Other descriptive name	FLUOROURACIL
D.3.9.4	EV Substance Code	SUB07721MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	400 to 2400
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

Patients with locally advanced or metastatic CRC, wild type KRAS/NRAS (exon 2, 3, 4) will be enrolled.

Se inscribirán pacientes con CCR de progresión local o metastásico, con genes KRAS/NRAS de tipo salvaje (exones 2, 3, 4).

E.1.1.1

Medical condition in easily understood language

Colorectal Cancer

Cancer Colorrectal

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	18.1
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

Primary Objective of Dose-Escalation Phase (Phase 1b):
To determine the MTD and RP2D of Sym004 when administered by intravenous (iv) infusion every second week in combination with a standard dosing regimen of FOLFIRI (folinic acid, 5-flurouracil, irinotecan) to patients with locally advanced or metastatic colorectal cancer (CRC).

Primary Objective of Dose-Expansion Phase (Phase 2a):
To evaluate the antineoplastic effect of Sym004 when administered at the RP2D in combination with FOLFIRI to patients with locally advanced or metastatic CRC.

Establecer la DMT y la DRF2 de Sym004 cuando se administra por infusión IV cada dos semanas en combinación con una pauta posológica estándar de FOLFIRI (ácido fólico [AF; leucovorina], 5-fluorouracilo (5-FU), irinotecán) para pacientes con CCR metastásico o de progresión local.

E.2.2

Secondary objectives of the trial

Phase 1b:
? To determine the safety and tolerability of Sym004 when administered in combination with a standard dosing regimen of FOLFIRI
? Evaluation of the immunogenicity of Sym004
? Characterization of the PK profile of Sym004
? Preliminary evaluation of the antineoplastic effect of Sym004 plus FOLFIRI as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Phase 2a:
? Further evaluation of the safety and tolerability of Sym004 when administered at the RP2D in combination with FOLFIRI
? Continued evaluation of the immunogenicity of Sym004

Fase I b
Establecer la seguridad y tolerabilidad de Sym004 al ser administrado en combinación con una pauta posológica estándar de FOLFIRI
Evaluar de la inmunogenicidad de Sym004
? Caracterizar del perfil FC de Sym004
? Evaluación preliminar del efecto antineoplásico de Sym004 más FOLFIRI tal como se evalúa en los criterios de evaluación de la respuesta en tumores sólidos (RECIST v1.1)

Fase 2a:
Evaluación adicional de la seguridad y tolerabilidad de Sym004 al administrarse en DRF2 combinado con FOLFIRI
? Evaluación continuada de la inmunogenicidad de Sym004

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
? Failed* treatment for locally advanced or metastatic disease with first-line combination therapy of oxaliplatin and a fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after the last dose of first-line therapy and within < 3 months of C1/D1.
Patients who discontinued first-line therapy due to toxicity may be enrolled provided progression occurred < 6 months after the last dose of the first-line therapy regimen.
or
Failed* adjuvant therapy with combination therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months after the last dose of oxaliplatin and within < 6 months of C1/D1.
*Failure is defined as radiologic progression

? Eligible for FOLFIRI
? Measurable disease according to RECIST v1.1

Estado general (EG) de 0-1 según la escala del grupo de oncología de la cooperativa del este (ECOG).
Fracaso* en el tratamiento de enfermedad de progresión local o metastásica con tratamiento de primera línea combinado de oxaliplatino y fluoropirimidina, con o sin bevacizumab, durante el tratamiento o < 3 meses tras la última dosis del tratamiento de primera línea y en < 3 meses de C1/D1.
Los pacientes que interrumpan el tratamiento de primera línea debido a toxicidad podrán inscribirse en caso de que la progresión ocurra en < 6 meses después de la última dosis de la pauta de tratamiento de primera línea.
O bien:
Fracaso* en el tratamiento adyuvante en combinación con oxaliplatino y fluoropirimidina durante el tratamiento o en < 6 meses tras la última dosis de oxaliplatino y en el plazo de < 6 meses de C1/D1.
*El fracaso de define como progresión radiológica

E.4

Principal exclusion criteria

? Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or irinotecan (CPT-11)
? Any antineoplastic agent (standard or investigational) within 4 weeks prior to first administration of trial treatments
? Significant gastrointestinal abnormalities, as per defined criteria
? Significant cardiovascular disease, as per defined criteria
? Abnormal hematologic, renal or hepatic function, as per defined criteria

Tratamiento previo con anticuerpos anti-EGFR, inhibidores de moléculas pequeñas anti-EGFR o irinotecán (CPT-11)
Cualquier agente antineoplásico (estándar o en estudio) en las 4 semanas antes de C1/D1
Anormalidades gastrointestionales significativas definidas según criterios.
Enfermedad cardiovascular significativa definidas según criterio
Funcion hematológica, renal o hepática definidas según criterio

E.5 End points

E.5.1

Primary end point(s)

The Primary Endpoint of the Dose-Escalation Phase is the occurrence of Dose-Limiting Toxicities (DLT) observed during Cycle 1 of Sym004 administration in combination with FOLFIRI.

The Primary Endpoint of the Dose-Expansion Phase is confirmed objective antitumor response.

El criterio de valoración principal de la fase de incremento de la dosis es la aparición de toxicidades limitantes de la dosis (TLD) observadas durante el Ciclo 1 de la administración de Sym004 en combinación con FOLFIRI.

El criterio de valoración principal de la fase de expansión de la dosis es la confirmación de respuesta antitumoral objetiva.

E.5.1.1

Timepoint(s) of evaluation of this end point

Phase 1b- 1 year
Phase 2a- 2.5 year

Fase Ib - 1 año
Fase 2a - 2,5 años

E.5.2

Secondary end point(s)

Safety
? Nature, incidence and severity of AEs measured from baseline to end of trial participation
NOTE: Adverse Events are graded by the Investigator according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.4.03, in the following referred to as CTCAE)
? AEs leading to dose-reductions, dose delays and permanent treatment cessation
? Changes in safety laboratory values from baseline to end of trial participation
? Changes in vital signs and physical examinations from baseline to end of trial participation
? Occurrence of anti-drug antibodies (ADA) to Sym004 measured in serum at selected timepoints from baseline to end of trial participation

Anti-tumor Response
? Documented Objective Response (OR), defined as documented Partial Response (PR) or Complete Response (CR)
? Duration of OR from time of first PR or CR to progressive disease (PD)
? Changes in sum of diameters of target lesions from baseline to end of trial participation
? Stable Disease (SD) for > 4 months
? Time to documented disease progression, death, patient withdrawal or end of trial participation, whichever comes first

Pharmacokinetic Assessment (Dose Escalation only)
? PK endpoints, derived from the concentration-time curves of Sym004, mAb992 and mAb1024, respectively after the first and fourth infusion of Sym004:
AUCNorm, 0-336h Dose-normalized area under the concentration-time curve from End of Infusion (EOI) to 336 hours
AUC0-336h Area under the concentration-time curve from EOI to 336 hours
Cmax Maximum concentration
Tmax: Time to reach maximum concentration
Ctrough Trough concentration
T½ Elimination half-life
CL Clearance
V Volume of distribution

Pharmacodynamic and Biomarker Assessment
a. Urine and peripheral blood collection for assessment of biomarkers related to the EGFR pathway
b. Other potential biomarkers to be determined (i.e. genes, gene transcripts and proteins of the receptor tyrosine kinases (RTKs))

? La naturaleza, incidencia e intensidad de los AA medidos desde el inicio hasta el fin de la participación en el ensayo
NOTA: los AA los puntúa el investigador de acuerdo con los criterios de terminología común para acontecimientos adversos según el Instituto Nacional del Cáncer (NCI-CTCAA v.4.03, referidos como CTCAA de ahora en adelante)
? AA que desencadenen disminuciones de la dosis, retrasos de la dosis y cese permanente del tratamiento
? Cambios en los valores de seguridad del laboratorio desde el inicio hasta el final de la participación en el ensayo
? Cambios en las constantes vitales y exploraciones físicas desde el inicio hasta el final de la participación en el ensayo
? La incidencia de anticuerpos antifármaco (AAF) contra Sym004 medida en el suero en momentos seleccionados desde el inicio hasta el final de la participación en el ensayo
Respuesta antitumoral
? Respuesta objetiva (RO) documentada, definida como respuesta parcial (RP) documentada o respuesta completa (RC)
? Duración de la RO desde el momento de la primera RP o RC hasta la enfermedad progresiva (EP)
? Cambios en la suma de diámetros de las lesiones diana desde el inicio hasta el final de la participación en el ensayo
? Enfermedad estable (EE) durante > 4 meses
? Tiempo hasta la progresión de la enfermedad documentada, muerte, retirada del paciente o final de participación en el ensayo, lo que ocurra antes
Evaluación farmacocinética (solo incremento de la dosis)
? Criterios de valoración FC, derivados de las curvas de concentración-tiempo de Sym004, ACM992 y ACM1024, respectivamente, tras la primera y cuarta infusión de Sym004:
ABCnorm, 0-336h Área bajo la curva de concentración-tiempo normalizada por la dosis desde el final de la infusión (FDI) hasta 336 horas
ABC0-336h Área bajo la curva de concentración-tiempo desde el FDI hasta 336 horas
Cmáx Concentración máxima
Tmáx Tiempo hasta alcanzar la concentración máxima
Cmín Concentración mínima
t½ Semivida de eliminación
ACL Aclaramiento
V Volumen de distribución
Evaluaciones farmacodinámicas y de biomarcadores
a. Recogida de orina y sangre periférica para evaluar biomarcadores relacionados con la vía EGFR
b. Otros biomarcadores potenciales a determinar (por ejemplo, genes, transcriptores génicos y proteínas del receptor de la tirosina quinasa [RTK])

E.5.2.1

Timepoint(s) of evaluation of this end point

-PK Analysis - 1 year
-Biomarker - 2 year
-Safety - 2.5 year
-Tumor Response - 2 year

- Analisis farmacinético - 1 año
- Biomarcador - 2 años
- seguridad - 2,5 años
- respuesta tumoral - 2 años

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

Yes

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Ib/IIa

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

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

Spain

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of trial will be reached at the latest 1 month (28 +7 days) after the last patient has been withdrawn from trial treatments.

El fin de ensayo tendrá lugar al menos 1 mes (28 + 7 dias) antes de que el último paciente haya sido retirado de los tratamientos del 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

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

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

F.4.2.2

In the whole clinical trial

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)

End of Treatment/Follow-up: Once both Sym004 and FOLFIRI have been discontinued an End of Treatment (EOT) Visit will be performed within 10 days from the decision to withdraw treatment.
A follow-up visit will be performed 1 month after the last administration of Sym004/FOLFIRI (i.e. only after both treatments have been discontinued). This One Month Follow-up (1M FUP) visit will constitute the end of trial participation for the patient.

Fin de ensayo/Seguimiento: una vez que se haya discontinuado Sym004 y FOLFIRI tendrá lugar una visita fin de ensayo en los 10 días siguientes a la decisión de retirada del tratamiento
Se realizará una visita de seguimiento 1 mes después de la última administración de Sym004/FOLFIRI (p.ej. solo después de que ambos tratamientos se hayan discontinuado). Esta visita de seguimiento del mes 1 (1M FUO) consitituirá el fin de la participación del paciente en el ensayo.

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

2016-03-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-05-15

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