Clinical Trials Register

Summary
EudraCT Number:	2013-005532-23
Sponsor's Protocol Code Number:	CO-1686-019
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:	2014-04-30
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

2013-005532-23

A.3

Full title of the trial

TIGER-2: A Phase 2, Open-Label, Multicenter, Safety and Efficacy Study of Oral CO 1686 as 2nd Line EGFR-Directed TKI in Patients with Mutant EGFR Non-Small Cell Lung Cancer (NSCLC) with the T790M Resistance Mutation

TIGER-2: Estudio de fase II abierto, multicéntrico, sobre la seguridad y eficacia de CO-1686 por vía oral como tratamiento de segunda línea dirigido al EGFR en pacientes con carcinoma pulmonar amicrocítico con mutación de EGFR con la mutación de resistencia T790M

A.3.1

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

A Phase 2 clinical study to evaluate the safety and efficacy of the study medication CO-1686 in subjects with Previously Treated EGFR Non-Small Cell Lung Cancer

Estudio en fase 2 para evaluar la seguridad y la eficacia de la medicación del estudio CO-1686 en sujetos que han sido previamente tratados de cáncer de pulmón con células amicrocíticas con mutación del receptor del factor de crecimiento epidérmico

A.3.2

Name or abbreviated title of the trial where available

TIGER-2

A.4.1

Sponsor's protocol code number

CO-1686-019

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	Clovis Oncology, 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	Clovis Oncology, 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	Clovis Oncology UK Ltd
B.5.2	Functional name of contact point	Dr Lindsey Rolfe
B.5.3	Address:
B.5.3.1	Street Address	Sheraton House, Castle Park
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	CB3 0AX
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441223370037
B.5.6	E-mail	info@clovisoncology.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	CO-1686
D.3.2	Product code	CO-1686
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not applicable
D.3.9.1	CAS number	1446700-26-0
D.3.9.2	Current sponsor code	CO-1686
D.3.9.3	Other descriptive name	CO-1686
D.3.9.4	EV Substance Code	SUB126980
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	125
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: 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.3.1	Product name	CO-1686
D.3.2	Product code	CO-1686
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not applicable
D.3.9.1	CAS number	1446700-26-0
D.3.9.2	Current sponsor code	CO-1686
D.3.9.3	Other descriptive name	CO-1686
D.3.9.4	EV Substance Code	SUB126980
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	250
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

Previously treated NSCLC patients who have documented evidence of an
activating mutation in the EGFR gene and have failed treatment with an
EGFR inhibitor

Pacientes previamente tratados de cáncer de pulmón amicrocítico, con evidencia documentada de una mutación del receptor del factor de crecimiento epidérmico, y que han sido fallo en el tratamiento con un inhibidor del receptor del factor de crecimiento epidérmico

E.1.1.1

Medical condition in easily understood language

Patients with EGFR mutant Non-Small Cell Lung Cancer who have failed
treatment with an EGFR inhibitor

Pacientes con carcinoma pulmonar amicrocítico con mutación del EGFR o, que han sido fallo de tratamiento con un inhibidor del receptor de factor de crecimiento epidérmico

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10029514
E.1.2	Term	Non-small cell lung cancer NOS
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the antitumor efficacy of oral single agent CO-1686 , as measured by objective response rate (ORR), when administered to patients with EGFR-mutated,T790M positive, advanced non-small cell lung cancer (NSCLC) after tumor progression on one previous EGFR directed TKI

Evaluar la eficacia antitumoral del agente único por vía oral CO-1686 según la medición por la tasa de respuesta objetiva (TRO), cuando se administra a pacientes con carcinoma pulmonar amicrocítico (CPA) en estadio avanzado, mutación del EGFR y positivo para T790M después de la progresión tumoral en un ICT dirigido contra el EGFR

E.2.2

Secondary objectives of the trial

*To assess secondary measures of clinical efficacy (disease control rate (DCR), duration of response (DR), progression free survival (PFS), overall survival (OS)) following CO-1686 treatment
* To assess quality of life (QoL) by patient-reported outcomes (PRO) following CO-1686 treatment
* To evaluate the safety and tolerability of CO-1686
* To determine pharmacokinetics (PK) of CO-1686 using population PK (POPPK) methods and explore correlations between PK, exposure, response, and/or safety findings

*Evaluar las mediciones secundarias de la eficacia clínica (tasa de control de la enfermedad [TCE], duración de la respuesta [DR], supervivencia sin progresión [SSP], supervivencia general [SG]) después del tratamiento con CO-1686
* Evaluar la calidad de vida (CdV) según los desenlaces comunicados por el paciente (PRO, patient-reported outcomes) después del tratamiento con CO-1686
*Evaluar la seguridad y tolerabilidad de CO-1686
*Determinar la farmacocinética (FC) de CO-1686 en esta población de pacientes usando métodos de FC poblacional y explorar las correlaciones entre los hallazgos de FC, exposición, respuesta y/o seguridad

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histologically or cytologically confirmed metastatic or unresectable locally advanced, NSCLC
2. Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI (e.g., erlotinib, gefitinib, afatinib, or dacomitinib)
*EGFR TKI treatment discontinued ? 30 days prior to planned initiation of CO-1686
*The washout period for an EGFR inhibitor is a minimum of 3 days
*No intervening treatment between cessation of single agent EGFR TKI and planned initiation of CO-1686
*Previous treatment with <=1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)
*Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less
3. Documented evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion
4. Tumor with the T790M mutation, as confirmed by the central laboratory. Biopsy material obtained from either primary or metastatic tumor tissue and sent to the central laboratory must be within 28 days of dosing study drug and following disease progression on the first EGFR TKI
5. Measureable disease according to RECIST Version 1.1
6. Life expectancy of at least 3 months
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
8. Age >= 18 years (in certain territories, the minimum age requirement may be higher eg age >= 20 years in Japan and Taiwan)
9. Adequate hematological and biological function, confirmed by the
following laboratory values: E.g. Bone Marrow Function, Hepatic
Function, Renal Function and Electrolyte within normal range.
10. Written consent on an Institutional Review Board/Independent Ethics Committee-approved Informed Consent Form (ICF) prior to any study specific evaluation

1. CPA localmente avanzado irresecable o metastásico confirmado por histología o citología
2. Progresión de la enfermedad confirmada mediante evaluación radiológica mientras se recibía tratamiento con el primer agente ITC de EGFR único (p. ej., erlotinib, gefitinib, afatinib o dacomitinib)
*Interrupción del tratamiento con el ITC de EGFR ? 30 días antes del inicio previsto de CO-1686
*El período de reposo farmacológico mínimo para un inhibidor del EGFR es de 3 días
*Sin tratamiento intermedio entre la finalización del agente único ITC de EGFR y el inicio previsto de CO-1686
*Tratamiento anterior con un máximo de una quimioterapia anterior (excluyendo la quimioterapia neoadyuvante o adyuvante anterior, o quimiorradioterapia con intención curativa)
*Todo efecto secundario relacionado con el tratamiento inhibidor de EGFR anterior debe haber desaparecido hasta un grado 1 o inferior
3. Prueba documentada de un tumor con una o varias mutaciones del EGFR excluida la inserción del exón 20.
4. Tumor con la mutación T790M, confirmada por el laboratorio central. El material de biopsia obtenido bien del tejido tumoral primario o metastásico y enviado al laboratorio central debe haberse obtenido en los 28 días anteriores a la administración del fármaco del estudio y después de la progresión de la enfermedad con el primer ITC de EGFR.
5. Enfermedad mensurable conforme a RECIST, versión 1.1
6. Esperanza de vida de al menos 3 meses.
7. Estado funcional de entre 0 y 1, según el Grupo Oncológico Cooperativo del Este (ECOG)
8. Edad >= 18 años (en determinados territorios, el requisito de edad mínima puede ser mayor, p. ej., edad >= 20 años en Japón y Taiwán)
9. Función hematológica y biológica adecuada, confirmada por los valores de laboratorio siguientes: ej. Función de la médula ósea, función hepática, Función Renal y electrolitos dentro del rango normal.
10. Consentimiento informado en un formulario de consentimiento informado (FCI) aprobado por el Comité ético de investigación clínica (CEIC) antes de realizar las evaluaciones específicas del estudio

E.4

Principal exclusion criteria

Any of the following criteria will exclude patients from study participation:
1. Documented evidence of an Exon 20 insertion activating mutation in the EGFR gene
2. Any other malignancies within the last 5 years, except for adequately treated and resolved:
*in situ cervical cancer
*non-melanoma skin cancer
*ductal carcinoma in situ breast cancer
*localised thyroid malignancy treated by curative surgery
*localised prostate cancer
3. Known pre-existing interstitial lung disease
4. Brain metastases
5. Treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment [except corticosteroids and megesterol acetate], or immunotherapy) <= 14 days prior to treatment with CO-1686
6. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting CO-1686
7. Prior treatment with CO-1686, or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR eg AZD9291, HM61713, TAS-121
8. Any of the following cardiac abnormalities or history :
a. Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) >450 msec
b. Inability to measure QT interval on ECG
c. Personal or family history of long QT syndrome
d. Implantable pacemaker or implantable cardioverter defibrillator
e. Resting bradycardia <50 beats/min
9. Non-study related surgical procedures<=7 days prior to administration of CO 1686. In all cases, the patient must be sufficiently recovered and stable before treatment administration.
10. Females who are pregnant or breastfeeding
11. Refusal to use adequate contraception for fertile patients (females and males) while on treatment and for 6 months after the last dose of CO-1686
12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism)
13. Any other reason the investigator considers the patient should not participate in the study

Cualquiera de los criterios siguientes excluirá a los pacientes de la participación en el estudio:
1. Pruebas documentadas de una mutación activadora por inserción del exón 20 en el gen del EGFR
2. Cualquier otra neoplasia maligna en los últimos 5 años, excepto si se ha tratado de forma adecuada y se ha resuelto:
*Carcinoma cervicouterino in situ
*Carcinoma cutáneo no melanómico
*Cáncer de mama carcinoma canalicular in situ
*Neoplasia maligna tiroidea localizada tratada mediante operación quirúrgica curativa
*Cáncer de próstata localizado
3. Neumopatía intersticial preexistente conocida
4. Metástasis cerebrales
5. Tratamiento con medicamentos prohibidos (p. ej., tratamiento antineoplásico concurrente que incluye otra quimioterapia, radiación, hormonoterapia [excepto corticoesteroides y acetato de megesterol], o inmunoterapia) <=14 días antes del tratamiento con CO-1686
6. Pacientes que actualmente están recibiendo tratamiento con cualquier medicación que tenga el potencial de prolongar el intervalo QT y cuyo tratamiento no se pueda interrumpir o cambiar a un medicamento distinto antes de iniciar CO-1686
7. Tratamiento anterior con CO-1686 u otros fármacos que actúan sobre el EGFR mutante positivo para T790M que no afecten al EGFR natural como, por ejemplo, AZD9291, HM61713, TAS-121
8. Cualquiera de las siguientes anomalías cardíacas o historial:
a. Anomalías clínicamente significativas en el ECG de 12 derivaciones, intervalo QT corregido usando el método de Fridericia (QTCF) > 450 ms
b. Incapacidad para medir el intervalo QT en el ECG
c. Antecedentes personales o familiares de síndrome de QT largo
d. Marcapasos implantable o desfibrilador cardioversor implantable
e. Bradicardia en reposo < 50 latidos/min
9. Procedimientos quirúrgicos no relacionados con el estudio <= 7 días antes de la administración de CO-1686. En todos los casos, el paciente debe haberse recuperado lo suficiente y estar suficientemente estable antes de la administración del tratamiento.
10. Mujeres embarazadas o en período de lactancia
11. Negativa a usar anticonceptivos adecuados para pacientes fértiles (hombres y mujeres) durante el tratamiento y los 6 meses siguientes a la administración de la última dosis de CO-1686
12. Presencia de algún trastorno sistémico concomitante grave o inestable incompatible con el estudio clínico (p. ej., drogadicción, enfermedad intercurrente no controlada, como infección activa, trombosis arterial y embolia pulmonar sintomática)
13. Cualquier otra razón por la que el investigador considere que el paciente no debe participar en el estudio

E.5 End points

E.5.1

Primary end point(s)

ORR according to Response Criteria in Solid Tumors (RECIST) Version 1.1 as determined by independent radiology review (IRR)

TRO conforme a los criterios de respuesta en los tumores sólidos (RECIST), versión 1.1 según lo determine una revisión radiológica independiente (RRI)

E.5.1.1

Timepoint(s) of evaluation of this end point

From start of treatment until disease progression

Desde el inicio del tratamiento hasta la progresión de la enfermedad

E.5.2

Secondary end point(s)

*DR, DCR and PFS according to RECIST Version 1.1 as determined by IRR
*ORR, DR, DCR and PFS according to RECIST Version 1.1 as determined by Investigator Assessment
*OS
*Change from baseline in patient reported outcomes using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C30), EORTC Quality of Life Questionnaire Lung Cancer module (EORTC QLQ LC13), and the Dermatology Life Quality Index (DLQI)
*Treatment emergent adverse events (AEs), laboratory abnormalities and ECG abnormalities
*Plasma PK parameters for CO-1686 based on sparse sampling

*DR, TCE y SSP conforme a RECIST versión 1.1, según lo determine una RRI
*TRO, DR, TCE y SSP conforme a RECIST versión 1.1, según lo determine la evaluación del investigador
*SG
*Cambio en relación con el momento inicial en los desenlaces comunicados por el paciente usando el Cuestionario de calidad de vida QLQ-30 de la EORTC (Organización Europea para la Investigación y el Tratamiento del Cáncer), el módulo de carcinoma pulmonar del QLQ de la EORTC (QLQ-LC13) y el índice de calidad de vida dermatológica (DLQI)
*Acontecimientos adversos derivados del tratamiento, anomalías de laboratorio y anomalías en el ECG
*Parámetros FC en plasma para CO-1686 basados en muestreo disperso

E.5.2.1

Timepoint(s) of evaluation of this end point

From start of treatment until disease progression

Desde el inicio del tratamiento hasta la progresión de la enfermedad

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

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

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

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

France

Australia

Germany

Hong Kong

Korea, Republic of

Spain

Taiwan

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 trial will be completed when all enrolled patients have discontinued treatment in this protocol and completed the end-of-study follow-up visit.

El estudio estará finalizado cuando todos los pacientes seleccionados hayan discontinuado su tratamiento en este protocolo y hayan completado las visitas de seguimiento y de fin de 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

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

F.4.2.2

In the whole clinical trial

125

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)

After the end of treatment the patients will return to their normal SOC
medication.

Despues del fin del tratamiento los pacientes volverán a su medicación standar

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

2014-07-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-08-27

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Clinical trials