Clinical Trials Register

Summary
EudraCT Number:	2013-005108-32
Sponsor's Protocol Code Number:	BP29262
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:	2014-06-09
Trial results	View results

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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2013-005108-32

A.3

Full title of the trial

A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RO5520985 PLUS FOLFOX VERSUS BEVACIZUMAB PLUS FOLFOX IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER.

ESTUDIO DE FASE II, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE RO5520985 MÁS FOLFOX EN COMPARACIÓN CON BEVACIZUMAB MÁS FOLFOX EN PACIENTES CON CÁNCER COLORRECTAL METASTÁSICO SIN TRATAMIENTO PREVIO

A.3.1

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

A blinded phase II study to evaluate the efficacy and safety of 2 different treatments arms (RO5520985 plus standard chemotherapy FOLFOX versus bevacizumab plus standard chemotherapy FOLFOX) in patients who have not been treated before for their metastatic disease of colorectal cancer.

Estudio ciego de fase II para evaluar la eficacia y seguridad en 2 grupos de tratamiento diferentes (RO5520985 más quimioterapia estándar FOLFOX en comparación con bevacizumab más quimioterapia estándar FOLFOX) en pacientes con cáncer colorrectal metastásico sin tratamiento previo.

A.4.1

Sponsor's protocol code number

BP29262

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	F. Hoffmann-La Roche Ltd
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	F. Hoffman-La Roche Ltd
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	F. Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TSIL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+34 91 325 73 00
B.5.6	E-mail	global.rochegenentechtrials@roche.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	CrossMab Ang-2/VEGF
D.3.2	Product code	552-0985/F02-01
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	RO5520985
D.3.9.1	CAS number	RO5520985
D.3.9.2	Current sponsor code	RO5520985
D.3.9.3	Other descriptive name	RO5520985
D.3.9.4	EV Substance Code	SUB76433
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	25
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Avastin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Avastin
D.3.2	Product code	RO487-6646/F02-02
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	BEVACIZUMAB
D.3.9.1	CAS number	216974-75-3
D.3.9.2	Current sponsor code	RO4876646
D.3.9.4	EV Substance Code	SUB16402MIG
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	25
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 cancer of the colon or rectum where the tumor has already spread to other organs(s),

Pacientes con cáncer de colon o recto donde el tumor se ha extendido a otos órganos.

E.1.1.1

Medical condition in easily understood language

Patients with cancer of the colon or rectum where the tumor has already spread to other organs(s),

Pacientes con cáncer de colon o recto donde el tumor se ha extendido a otos órganos.

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	PT
E.1.2	Classification code	10052358
E.1.2	Term	Colorectal 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	17.0
E.1.2	Level	PT
E.1.2	Classification code	10055097
E.1.2	Term	Rectal 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	17.0
E.1.2	Level	PT
E.1.2	Classification code	10055114
E.1.2	Term	Colon cancer metastatic
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of Study BP29262 is to estimate the efficacy of RO5520985 in combination with oxaliplatin, folinic acid, and 5 fluorouracil (mFOLFOX-6) vs. bevacizumab in combination with mFOLFOX-6, as measured by progression-free survival (PFS).

El objetivo principal del estudio BP29262 consiste en evaluar la eficacia de RO5520985 en combinación con oxaliplatino, ácido folínico y 5 fluorouracilo (mFOLFOX 6) en comparación con bevacizumab en combinación con mFOLFOX 6, determinada mediante la supervivencia sin progresión (SSP).

E.2.2

Secondary objectives of the trial

?Evaluate the safety and tolerability of RO5520985 in combination with mFOLFOX-6
?Estimate the efficacy of RO5520985 in combination with mFOLFOX-6, as measured by overall survival, objective response rate, and duration of objective response
?Characterize the pharmacokinetics of RO5520985 when combined with mFOLFOX-6

? Evaluar la seguridad y la tolerabilidad de RO5520985 en combinación con mFOLFOX 6.
? Evaluar la eficacia de RO5520985 en combinación con mFOLFOX 6, determinada mediante la supervivencia global, la tasa de respuesta objetiva y la duración de la respuesta objetiva.
? Definir la farmacocinética de RO5520985 cuando se combina con mFOLFOX 6.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Histologically or cytologically confirmed mCRC not amenable to potentially curative resection with at least one measurable metastatic lesion, as defined by RECIST v1.1
a)Results of local RAS mutational analysis must be available for stratified randomization
b)Representative tumor specimens in FFPE blocks (preferred) or slides must be available for central extended RAS mutational analysis testing
2.Signed written informed consent, obtained prior to any screening procedure
3.Age> 18 years
4.ECOG (WHO) performance status of 0 or 1
5.Adequate hematologic, liver, renal, coagulation and cardiovascular function
6.Recovery from all reversible adverse events of previous medical therapies to baseline or NCI CTCAE Grade 1, except for alopecia (any grade)
7.Negative serum pregnancy test within 7 days prior to starting study treatment in premenopausal women and women < 2 years after the onset of menopause

1. CCRm confirmado mediante histología o citología, no susceptible de resección potencialmente curativa, con al menos una lesión metastásica mensurable, definida conforme a los criterios RECIST, versión 1.1.
a) Los resultados del análisis local de mutaciones RAS deberán encontrarse disponibles para efectuar la aleatorización estratificada.
b) Tendrá que haber muestras tumorales representativas en bloques FFPE (preferible) o extensiones disponibles para efectuar el análisis central ampliado de mutaciones RAS.
2. Consentimiento informado por escrito firmado, obtenido antes de realizar cualquier procedimiento de selección.
3. Edad ? 18 años.
4. Estado funcional del ECOG (OMS) de 0 o 1.
5. Función hematológica, hepática, renal, coagulación y cardiovascular adecuada.
6. Recuperación de todos los acontecimientos adversos reversibles de tratamientos médicos anteriores hasta la situación basal o un grado 1 según los CTCAE del NCI, salvo alopecia (cualquier grado).
7. Prueba de embarazo en suero negativa en los 7 días previos al comienzo del tratamiento del estudio en mujeres premenopáusicas o < 2 años después del comienzo de la menopausia.

E.4

Principal exclusion criteria

1.Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, immunotherapy, hormonal therapy) before Day 1 of Cycle 1 for treatment of mCRC
Patients who received prior systemic adjuvant therapy or radiotherapy for CRC are not excluded if the time interval from last administration of adjuvant therapy until disease progression is > 12 months
2.Prior radiotherapy within 28 days prior to Day 1 of Cycle 1, except palliative radiotherapy to bone lesions within 7 days prior to Day 1 of Cycle 1
3.Symptomatic CNS metastases or carcinomatous meningitis:
4.Significant cardiovascular or cerebrovascular disease within 6 months prior to Day 1 of Cycle 1
5.Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
6.Current use of anticoagulants (e.g., warfarin or any other coumadin-derivate coagulants) at therapeutic doses within 7 days prior to study drug administration. Prophylactic use of unfractioned heparin or low molecular weight heparin (LMWH) is permitted (e.g., enoxaparin 40 mg QD)
7.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study or nonrecovery from side effects of any such procedure
8.History of abdominal or tracheo-oesophageal fistula or GI perforation or intra abdominal abscess within 6 months prior to Day 1
9.Clinical signs or symptoms of GI obstruction or a requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
10.Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
11.History of bronchopulmonary hemorrhage NCI CTCAE > Grade 2 within 4 weeks prior to Day 1 of Cycle 1
12.Severe, nonhealing or dehiscing wound, active ulcer, or untreated bone fracture
13.Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5 FU toxicity

1. Cualquier tratamiento sistémico previo (quimioterapia, terapia con anticuerpos, inhibidores de la tirosina cinasa, inmunoterapia, tratamiento hormonal) antes del día 1 del ciclo 1 como tratamiento del CCRm.
a) No se excluirá a los pacientes que hayan recibido tratamiento sistémico o radioterapia adyuvante para el CCR si el intervalo de tiempo desde la última administración del tratamiento adyuvante hasta la progresión de la enfermedad es > 12 meses.
2. Radioterapia en los 28 días previos al día 1 del ciclo 1, excepto radioterapia paliativa de lesiones óseas en los 7 días previos al día 1 del ciclo 1.
3. Metástasis sintomáticas en el SNC o meningitis carcinomatosa.
4. Enfermedad cardiovascular o cerebrovascular importante en los 6 meses previos al día 1 del ciclo 1.
5. Datos de diátesis hemorrágica o coagulopatía importante (en ausencia de tratamiento anticoagulante).
6. Uso activo de anticoagulantes (por ejemplo, warfarina u otros coagulantes cumarínicos) en dosis terapéuticas en los 7 días previos a la administración del fármaco del estudio. Se permite el uso preventivo de heparina no fraccionada o heparina de bajo peso molecular (HBPM) (por ejemplo, enoxaparina 40 mg una vez al día).
7. Intervención de cirugía mayor, biopsia abierta o lesión traumática importante en los 28 días previos al día 1 o previsión de la necesidad de una intervención de cirugía mayor durante el transcurso del estudio o de no recuperación de los efectos secundarios de dicha intervención.
8. Antecedentes de fístula abdominal o traqueoesofágica o perforación digestiva o absceso intraabdominal en los 6 meses previos al día 1 del ciclo 1.
9. Signos o síntomas clínicos de obstrucción digestiva o necesidad rutinaria de hidratación parenteral, nutrición parenteral o alimentación por sonda.
10. Signos de aire libre en la cavidad abdominal no explicados por una paracentesis o una intervención quirúrgica reciente.
11. Antecedentes de hemorragia broncopulmonar de grado ? 2 según los CTCAE del NCI en las 4 semanas previas al día 1 del ciclo 1.
12. Herida grave, que no cicatriza o dehiscente, úlcera activa o fractura ósea no tratada.
13. Carencia conocida de dihidropirimidina deshidrogenasa o polimorfismo en el gen de la timidilato sintasa que predispone al paciente a presentar toxicidad por 5 FU.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint for Study BP29262 is progression-free survival (PFS), defined as the time from randomization to the date of first documented occurrence of progression based on RECIST v1.1 criteria as determined by the Investigator or death from any cause on study, whichever occurs first.

El criterio de valoración principal del estudio BP29262 será la supervivencia sin progresión (SSP), definida como el tiempo transcurrido entre la aleatorización y la fecha del primer episodio confirmado de progresión con arreglo a los criterios RECIST, versión 1.1, según lo determinado por el investigador, o la muerte por cualquier causa durante el estudio, lo que ocurra antes.

E.5.1.1

Timepoint(s) of evaluation of this end point

endpoint Tumor assessments will be performed every 8 (+/-1) weeks acc. RECIST 1.1.

Evaluación tumoral cada 8 (+/- 1) semanas de acuerdo a criterios RECIST.

E.5.2

Secondary end point(s)

Secondary Efficacy End Points ?Objective response rate (ORR). Objective response rate is defined as the rate of patients with an objective tumor response, i.e. partial response (PR) or complete response (CR) as determined by the Investigator using RECIST v1.1 criteria on two consecutive occasions at least 4 weeks apart
?Duration of response, defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study
?Overall Survival, defined as the time from randomization until death from any cause
Secondary Safety End Points
?Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
?Changes in hematology, biochemistry, coagulation, specifically those associated with vascular and renal function
?Physical examinations (including ECOG), vital signs and ECG
?Incidence and titers of human anti-human antibodies (HAHAs)
?Adverse events leading to RO5520985, bevacizumab, or chemotherapy discontinuation
?Incidence of the following selected adverse events according to NCI CTCAE, v4.03:
Arterial hypertension (Grade 3)
Proteinuria (Grade 3)
Arterial thromboembolic events (any grade)
Venous thromboembolic events (Grade 3)
Vascular disorder - other: Thrombotic microangiopathy (any grade)
Gastrointestinal perforation (any grade)
Fistula involving an internal organ (any grade)
Fistulae (Grade 4)
Wound dehiscence/complication (Grade 3)
Bleeding/hemorrhage (Grade 3)
Pulmonary bleeding (Grade 2)
CNS bleeding (Grade 2)
Congestive heart failure (Grade 3)
Reversible posterior leukoencephalopathy syndrome (any grade)
Secondary PK End Points :
?The PK profile of RO5520985 will be characterized with the plasma concentration time data following IV administration of RO5520985, and will include the following parameters: Cmax, Cmin, Tmax, t1/2, AUC, AUC, CL, Vss, accumulation ratio (RA)
?The PK profiles of oxaliplatin (free and total) and 5-FU will be characterized with the plasma concentration-time data following IV administration of FOLFOX, and will include the following parameters: Cmax, Cmin, Tmax, t1/2, AUC (when applicable)
?Additional PK parameters may be evaluated as appropriate

Criterios de valoración secundarios de la eficacia
? Tasa de respuestas objetivas. La tasa de respuestas objetivas (TRO) se determinará como la proporción de pacientes con una respuesta tumoral objetiva (respuesta completa [RC] o parcial [RP]), determinada por el investigador con arreglo a los criterios RECIST, versión 1.1, en dos ocasiones consecutivas separadas por un mínimo de 4 semanas.
? Duración de la respuesta objetiva, definida como el tiempo transcurrido entre la respuesta inicial (RC o RP) y la progresión de la enfermedad o la muerte por cualquier causa durante el estudio.
? Supervivencia global, definida como el tiempo transcurrido entre la aleatorización y la muerte por cualquier causa.

Criterios de valoración secundarios de la seguridad
? Incidencia e intensidad de los acontecimientos adversos (AA) y acontecimientos adversos graves (AAG), graduados con arreglo a los Criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute (CTCAE del NCI), versión 4.03.
? Variaciones de la hematología, bioquímica y coagulación, en concreto, de las asociadas a las funciones vascular y renal.
? Exploración física (incluido el estado funcional del ECOG), constantes vitales y ECG.
? Incidencia y títulos de anticuerpos humanos antihumanos (HAHA).
? Acontecimientos adversos que motiven la suspensión de RO5520985, bevacizumab o la quimioterapia.
? Incidencia de los siguientes acontecimientos adversos seleccionados con arreglo a los CTCAE del NCI, versión 4.03:
Hipertensión arterial (grado ? 3).
Proteinuria (grado ? 3).
Episodios tromboembólicos arteriales (cualquier grado).
Episodios tromboembólicos venosos (grado ? 3).
Otros trastornos vasculares: microangiopatía trombótica (cualquier grado).
Perforación digestiva (cualquier grado).
Fístulas con afectación de un órgano interno (cualquier grado).
Fístulas (grado 4).
Dehiscencia/complicaciones de heridas (grado ? 3).
Hemorragia (grado ? 3).
Hemorragia pulmonar (grado ? 2).
Hemorragia del SNC (grado ? 2).
Insuficiencia cardíaca congestiva (grado ? 3).
Síndrome de leucoencefalopatía posterior reversible (cualquier grado).

Criterios de valoración farmacocinéticos secundarios:
? El perfil FC de RO5520985 se determinará con los datos de concentración plasmática tiempo tras la administración IV de RO5520985 e incluirá los siguientes parámetros: Cmax, Cmin, Tmax, t1/2, AUC, AUC?, CL, Vss y cociente de acumulación (CA).
? El perfil FC de oxaliplatino (total y libre) y 5 FU se determinará con los datos de concentración plasmática tiempo tras la administración IV de FOLFOX e incluirá los siguientes parámetros: Cmax, Cmin, Tmax, t1/2 y AUC (cuando proceda).
? Podrán evaluarse otros parámetros FC según proceda.

E.5.2.1

Timepoint(s) of evaluation of this end point

Please see Schedule of assessment for the different timepoints of safety, PK and efficacy measurements.

Ver calendario de evaluaciones para los diferentes tiempos de seguridad, FC y medidas de eficacia.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

E.8.2.3.1

Comparator description

Folfox

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Austria

Belgium

Canada

France

Italy

Spain

United Kingdom

United States

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 study will formally end once the survival follow-up is complete or the last patient has completed the EoS Visit or is withdrawn from the study prior to that time (whichever occurs last), but may be prematurely terminated by the Sponsor.

El estudio finalizará formalmente una vez que se complete el seguimiento de la supervivencia o que el último paciente haya completado la visita de FDE o sea retirado del estudio antes de ese momento (lo que ocurra más tarde), aunque el promotor podrá darlo por finalizado de forma prematura.

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:

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

100

F.4.2.2

In the whole clinical trial

150

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)

All patients, also in case of early discontinuation, will attend a safety visit 21 ( > 7) days after receiving the last administration of RO5520985, which is the End of Study (EoS) Visit. Patients off study will receive standard of care for the stage of their disease.

Todos los pacientes, incluso en caso de retirada prematura, acudirán a una visita de seguridad 21 (± 7) días después de recibir la última dosis de RO5520985, correspondiente a la visita de final del estudio (FDE). Los pacientes que dejen de participar en el estudio recibirán el tratamiento de referencia para el estadio de la enfermedad.

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-06-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-08-09

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