Clinical Trials Register

Summary
EudraCT Number:	2012-000317-36
Sponsor's Protocol Code Number:	0646-025
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:	2012-04-26
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

2012-000317-36

A.3

Full title of the trial

A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab
(MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels

Ensayo clínico de fase IIA abierto, adaptativo, aleatorizado, de dalotuzumab (MK 0646) en combinación con irinotecán frente a cetuximab e irinotecán en pacientes con cáncer rectal metastásico (CRm) que expresa niveles altos de IGF-1/niveles bajos de IGF-2

A.3.1

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

Phase IIa trial of MK0646 Tx in combo w/ Irinotecan vs Cetuximab and Irinotecan for mRC patients

Ensayo clínico fase IIA de MK-0646 en combinación con Irinotecan frente a Cetuximab más Irinotecan en pacientes con cáncer rectal metastásico

A.3.2

Name or abbreviated title of the trial where available

Phase IIa trial of MK0646 Tx in combo w/ Irinotecan vs Cetuximab and Irinotecan for mRC patients

Ensayo clínico fase IIA de MK-0646/ Irinotecan frente a Cetuximab/Irinotecan en pacientes con cáncer

A.4.1

Sponsor's protocol code number

0646-025

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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.1.3.4	Country	United States
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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck, Sharp & Dohme de España, S.A.
B.5.2	Functional name of contact point	Marta Arias-Salgado
B.5.3	Address:
B.5.3.1	Street Address	C/ Josefa Valcárcel, 38
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28027
B.5.3.4	Country	Spain
B.5.4	Telephone number	34.616105879
B.5.5	Fax number	34913210590
B.5.6	E-mail	ensayos_clinicos@merck.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	dalotuzumab
D.3.2	Product code	MK-0646
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	dalotuzumab
D.3.9.1	CAS number	1005389-60-5
D.3.9.2	Current sponsor code	MK-0646
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	20
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	Erbitux
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck KGaA
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.3.1	Product name	Cetuximab
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	CETUXIMAB
D.3.9.1	CAS number	205923-56-4
D.3.9.4	EV Substance Code	SUB01178MIG
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	5
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: 3
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	Campto
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER, S.L.
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.3.1	Product name	Irinotecan
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.3.9.4	EV Substance Code	SUB08295MIG
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	20
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	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	Campto
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER, S.L.
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.3.1	Product name	Irinotecan
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.3.9.4	EV Substance Code	SUB08295MIG
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	20
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

rectal cancer

Cancer rectal

E.1.1.1

Medical condition in easily understood language

cancer of the rectum

cancer en el recto

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10038038
E.1.2	Term	Rectal cancer
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

To compare PFS of patients with wtKRAS mRC with High IGF-1/Low IGF-2 levels when treated with Dalo + Irino relative to patients treated with Cetux + Irino

Comparar la supervivencia sin progresión de los pacientes con carcinoma rectal metastásico con gen KRAS no mutado con expresión alta de IGF 1/baja de IGF 2 cuando se tratan con dalotuzumab + irinotecán con la de los pacientes tratados con cetuximab + irinotecán.

E.2.2

Secondary objectives of the trial

To evaluate the ORR of patients with wtKRAS mRC with High IGF-1/Low IGF-2 levels when treated with Dalo + Irino compared to patients with Cetux + Irino

Evaluar la tasa de respuestas objetivas de los pacientes con carcinoma rectal metastásico con gen KRAS no mutado con expresión alta de IGF 1/baja de IGF 2 tratados con dalotuzumab + irinotecán en comparación con los pacientes tratados con cetuximab + irinotecán.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient has metastatic colorectal cancer whose primary tumor originated from the rectum.
2. Patient has archival (recent or remote) tumor, or newly obtained formalin-fixed tissue available for analysis for biomarker studies. Archival specimens must be tumor block, surgical specimens or core needle biopsy specimens. (Fine needle biopsies are not adequate.) Please refer to Procedures Manual for details on sample collection and processing.
3. Patient's tumor is KRAS wild type as determined by testing at the program central laboratory during the screening period as outlined in the dalotuzumab PN025 Assay Charter.
4. Patient's whose tumor over-expresses IGF-1, determined by the central laboratory during the screening. The IGF-1 level determination is outlined in the dalotuzumab PN025 Assay Charter.
5. Patient has at least one measurable lesion greater than or equal to 15 mm. (Refer to the Investigators? Imaging Operations Manual [within the Procedures Manual] for detailed information].
6. Patient?s disease has progressed after treatment with both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy. Note: Failing oxaliplatin would include failure due to toxicities. Note: Failing irinotecan requires a minimum previous exposure to irinotecan of two cycles.
7. Patient has performance status 0-1 on the ECOG Performance Scale.

1.Cáncer colorrectal metastásico cuyo tumor primario se originó en el recto.
2. Disponibilidad de tumor de archivo (reciente o previo) o de tejido fijado en formol recién obtenido para el análisis de los estudios de biomarcadores. Las muestras archivadas deberán ser un bloque tumoral, especímenes quirúrgicos o muestras de biopsia con aguja gruesa. (las biopsias obtenidas con aguja fina no son adecuadas). Véanse en el Manual de procedimientos los detalles sobre la obtención y el proceso de las muestras.
3. El tumor del paciente contiene KRAS no mutado según las pruebas realizadas en el laboratorio central del programa durante el período de selección del modo indicado en los estatutos de análisis del estudio PN025 de dalotuzumab.
4. El tumor del paciente sobreexpresa IGF 1, según la determinación del laboratorio central durante la selección. La determinación de la concentración de IGF 1 se describe en los estatutos de análisis del estudio PN025 de dalotuzumab.
5. El paciente tiene al menos una lesión medible de 15 mm o más. (Véase información detallada en el Manual de procedimientos de imagen del investigador [dentro del Manual de Procedimientos]).
6. La enfermedad del paciente ha progresado después del tratamiento con regímenes que contenían irinotecán y oxaliplatino y debe haber progresado al completarse su última línea de tratamiento o en los 3 meses siguientes. Nota: El fracaso del oxaliplatino incluiría el fracaso debido a efectos tóxicos. Nota: Para considerar que el irinotecán ha fracasado se precisa una exposición previa mínima a él de dos ciclos.
7. Una edad mínima de 18 años en el día de la firma del consentimiento informado.

E.4

Principal exclusion criteria

1. Patient has a mutant KRAS (mutKRAS) metastatic rectal cancer determined by testing at the program central laboratory during the screening period.
2. Patient has a high IGF-2 expressing metastatic rectal cancer determined by testing at the program central laboratory during the screening.
3. Patient is a known diabetic patient who is poorly controlled (HbA1c >8%).
4. Patient who has had chemotherapy or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery.
5. Patient who has had radiotherapy within two weeks prior to initial dosing on this study, unless the radiotherapy was for management of pain.
6. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the investigational agent, whichever is longer, of initial dosing on this study.
7. Patient could not complete previous course of irinotecan due to intolerable toxicity, other than discontinuation due to fatigue following prolonged administration (>4 months exposure).

1. Cáncer rectal metastásico con KRAS mutante (mutKRAS) determinado mediante análisis en el laboratorio central del programa durante el período de selección.
2. Cáncer rectal metastásico con expresión de IGF 2 alta determinada mediante pruebas en el laboratorio central del programa durante la selección.
3. Diabetes conocida mal controlada (HbA1c > 8 %).
4. Quimioterapia o terapia biológica en las 2 semanas previas a la dosis inicial de fármaco de este estudio, efectos tóxicos de fármacos administrados dos semanas antes no resueltos al menos a un grado 1 o al estado basal, o intervención quirúrgica en las 3 semanas previas.
5. Radioterapia en las dos semanas previas a la administración inicial de este estudio, a menos que fuera para el control del dolor.
6. Participación actual o previa en un estudio con un compuesto o producto sanitario en investigación en los 30 días o 5 semividas del fármaco en investigación previos a la administración inicial en este estudio, lo que sea más largo.
7. Imposibilidad de completar el ciclo anterior del irinotecán por toxicidad intolerable distinta de la retirada por cansancio tras la administración prolongada (exposición >4 meses).

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival

Supervivencia sin progresión

E.5.1.1

Timepoint(s) of evaluation of this end point

Screening, Cycle 1/Day 42 (+/- 3days) and every 42 days thereafter until patient progresses

Screening, ciclo 1/day 45 (+/- 3 dias) y a partir de cada 42 días hasta que el paciente progrese

E.5.2

Secondary end point(s)

Overall Response Rate

Tasa de respuestas objetivas

E.5.2.1

Timepoint(s) of evaluation of this end point

Screening, Cycle 1/Day 42 (+/- 3days) and every 42 days thereafter until patient progresses

Screening, ciclo 1/day 45 (+/- 3 dias) y a partir de cada 42 días hasta que el paciente progrese

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

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

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)

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

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

Brazil

Chile

Korea, Democratic People's Republic of

New Zealand

Peru

Taiwan

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

When the study reaches 42 PFS events

finalizará cuando hayan ocurrido 42 episodios de supervivencia sin progresión

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)

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)

Active patients will continue to receive treatment on their assigned treatment arm until the final outcome of the study is determined. Based on the final outcome of the study, patient treatment regimens for those patients still on study treatment may be adjusted as detailed in the protocol.

Los pacientes activos seguirán recibiendo tratamiento en el grupo al que se les haya asignado hasta que se determine el resultado final del estudio.
Basándose en el resultado final del estudio, los regímenes terapéuticos de los pacientes que sigan recibiendo el tratamiento del estudio pueden ajustarse como se indica en el protocolo

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	Almac Diagnostics. Clinical Testing Services
G.4.3.4	Network Country	United Kingdom

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-06-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-12-09

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