Clinical Trials Register

Summary
EudraCT Number:	2010-019578-34
Sponsor's Protocol Code Number:	MEK113487
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:	2010-09-23
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

2010-019578-34

A.3

Full title of the trial

Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, del inhibidor de MEK GSK1120212 y Gemcitabina frente a placebo y Gemcitabina en sujetos con cáncer de páncreas metastásico.
A Randomized, Double-Blind Placebo-Controlled Phase II Study of the MEK inhibitor GSK1120212 plus Gemcitabine vs. Placebo plus Gemcitabine in Subjects with Metastatic Pancreatic Cancer

A.4.1

Sponsor's protocol code number

MEK113487

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline, S.A.
B.1.3.4	Country	Spain
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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.3.2	Product code	GSK1120212
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	871700-17-3
D.3.9.2	Current sponsor code	GSK1120212
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	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.3.2	Product code	GSK1120212
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	871700-17-3
D.3.9.2	Current sponsor code	GSK1120212
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	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.3.2	Product code	GSK1120212
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	871700-17-3
D.3.9.2	Current sponsor code	GSK1120212
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cáncer de páncreas metastásico

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13
E.1.2	Level	LLT
E.1.2	Classification code	10033605
E.1.2	Term	Cáncer pancreático metastásico

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo principal es comparar la supervivencia global (SG) de los sujetos tratados con GSK1120212 más gemcitabina con la de los que reciban placebo más gemcitabina.
El criterio de valoración principal de la eficacia se presenta en la sección 7.2.1.1 del protocolo.

E.2.2

Secondary objectives of the trial

Los objetivos secundarios de eficacia son los siguientes:
- Comparar la supervivencia libre de progresión (SLP) de los sujetos tratados con GSK1120212 más gemcitabina con la de los que reciban placebo más gemcitabina.
- Comparar la tasa de respuesta global (TRG) de los sujetos tratados con GSK1120212 más gemcitabina con la de los que reciban placebo más gemcitabina.
- Comparar la duración de la respuesta de los sujetos tratados con GSK1120212 más gemcitabina con la de los que reciban placebo más gemcitabina.
Los criterios de valoración secundarios de la eficacia se presentan en la sección 7.2.1.2 del protocolo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Consentimiento informado por escrito firmado.
2. Diagnóstico confirmado histológica o citológicamente de adenocarcinoma de páncreas metastásico (estadio IV) con enfermedad medible o no medible según los criterios RECIST 1.1.
3. Puntuación del Estado Funcional de 0 o 1 en la escala del Eastern Cooperative Oncology Group (ECOG) [Oken, 1982] (véase el Apéndice 4).
4. Todas las toxicidades relacionadas con el tratamiento previo deben ser de un grado <= 1 (excepto la alopecia) según los CTCAE (versión 4.0) en el momento de la aleatorización.
5. Función orgánica basal adecuada, definida en la Tabla 5 del protocolo.
6. 18 años de edad o más.
7. Las mujeres en edad fértil deberán presentar un resultado negativo en la prueba de embarazo en suero en los 14 días previos a la administración de la primera dosis del tratamiento del estudio, y se comprometerán a utilizar un método anticonceptivo eficaz, como se define en la sección 7.3.7, durante el estudio y durante las 4 semanas siguientes a la administración de la última dosis del fármaco del estudio.
y
Los varones con una pareja femenina en edad fértil deberán haberse sometido a una vasectomía previa o accederán a usar métodos anticonceptivos eficaces según se describe en la sección 7.3.7, desde la administración de la primera dosis de la medicación del estudio hasta 16 semanas después de la última dosis de la misma.
8. Poder tragar y retener la medicación administrada por vía oral y no presentar anomalías digestivas de importancia clínicamente que pudieran alterar la absorción, como un síndrome de malabsorción o una resección importante del estómago o intestino.

E.4

Principal exclusion criteria

1. Mujeres en período de lactancia.
2. Antecedentes de otro proceso maligno.
Excepción: podrán participar los sujetos que hayan permanecido sin enfermedad durante 5 años y los que tengan antecedentes de un cáncer de piel distinto del melanoma totalmente resecado o de un carcinoma in situ tratado satisfactoriamente. Los sujetos con segundas neoplasias malignas inactivas o tratadas definitivamente podrán ser reclutados. Consulte con el monitor médico de GSK para comprobar si las segundas neoplasias malignas cumplen los requisitos especificados.
3. Cualquier trastorno médico (salvo las neoplasias malignas ya señaladas), psiquiátrico o de otro tipo preexistente que sea grave o inestable y que, en opinión del monitor médico de GSK, podría interferir en la seguridad del sujeto, la obtención del consentimiento informado o el cumplimiento de los procedimientos del estudio.
4. Tratamiento sistémico previo (quimioterapia, inmunoterapia, tratamiento hormonal, tratamiento dirigido o cualquier fármaco contra el cáncer en investigación) para el adenocarcinoma pancreático metastásico.
- Se permite el tratamiento previo con 5-FU o con gemcitabina administrado como radiosensibilizador durante y hasta 4 semanas después de la radioterapia.
- Se permite la quimioterapia sistémica previa en el contexto adyuvante. Sin embargo, el tratamiento previo con gemcitabina sólo se permitirá en caso de que la recidiva tumoral se produzca al menos 6 meses después de finalizar la administración de la última dosis de gemcitabina.
5. Antecedentes de neumopatía intersticial o neumonitis.
6. Radioterapia completada en las 2 semanas previas a la aleatorización.
- Se permite la radioterapia definitiva en zonas distintas de la región torácica que afecte a los pulmones, si ha finalizado al menos 4 semanas antes de la aleatorización y las toxicidades se han resuelto según el criterio de inclusión N.º 4.
- Se permite la radioterapia limitada (como cuidados paliativos) en zonas distintas de la región torácica, si finaliza al menos 2 semanas antes de la aleatorización y las toxicidades se han resuelto según el criterio de inclusión N.º 4.
7. Tener una reacción de hipersensibilidad inmediata o retardada conocida al dimetilsulfóxido (DMSO).
8. Uso actual de una medicación prohibida (véase la sección 6.2).
9. Antecedentes o pruebas/riesgos actuales de oclusión de las venas retinianas (OVR) o retinopatía serosa central (RSC):
- Antecedentes o factores predisponentes de OVR o RSC (por ejemplo, glaucoma o hipertensión ocular no controlados, enfermedad sistémica no controlada, como hipertensión, diabetes mellitus o antecedentes de hiperviscosidad o síndromes de hipercoagulabilidad).
- Afección retiniana visible según lo evaluado mediante exploración oftalmológica que se considere un factor de riesgo de OVR o RSC tal y como:
- Signos de nueva excavación de la papila óptica
- Datos de nuevos defectos del campo visual en la perimetría automática
- Presión intraocular > 21 mm Hg medida mediante tonografía
10. Metástasis cerebrales o leptomeníngeas o compresión de la médula espinal sintomáticas o sin tratamiento.
- Los sujetos tratados previamente por estas dolencias que han tenido enfermedad estable del sistema nervioso central (SNC) (demostrada con estudios de imagen consecutivos) durante >3 meses, que se encuentran asintomáticos y sin corticosteroides o que reciben una dosis estable de corticosteroides durante al menos 1 mes antes del día 1 del estudio son elegibles.
- No se permite que los sujetos reciban antiepilépticos inductores enzimáticos (MAIE).
11. Antecedentes de síndromes coronarios agudos (incluida la angina de pecho inestable), angioplastia coronaria o colocación de endoprótesis en los últimas 6 meses.
12. QTcB >= 480 ms.
13. Antecedentes o signos de arritmias no controladas clínicamente significativas.
- Los sujetos con fibrilación auricular controlada durante >1 mes antes del día 1 del estudio son elegibles.
14. Antecedentes o indicios actuales de insuficiencia cardiaca congestiva de clase >= II según la New York Heart Association (NYHA; Apéndice 4).

E.5 End points

E.5.1

Primary end point(s)

El criterio de valoración principal del estudio es la Supervivencia global, definida como el tiempo transcurrido desde la aleatorización hasta el fallecimiento por cualquier causa.

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

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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)

E.8.2.2

Placebo

Yes

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

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

Information not present in EudraCT

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

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	15
F.4.2	For a multinational trial
F.4.2.1	In the EEA	50
F.4.2.2	In the whole clinical trial	150

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

2010-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-11-10

P. End of Trial
P.	End of Trial Status	Completed

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