Clinical Trials Register

Summary
EudraCT Number:	2016-001099-31
Sponsor's Protocol Code Number:	I5B-MC-JGDP
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:	2017-05-08
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2016-001099-31

A.3

Full title of the trial

A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer

Estudio de fase 1b (abierto) / fase 2 (aleatorizado, con doble enmascaramiento), en el que se evalúan nab-paclitaxel y gemcitabina, con o sin olaratumab, como tratamiento de primera línea del cáncer de páncreas metastásico

A.3.1

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

A study of nab-paclitaxel and gemcitabine with or without olaratumab for treatment of pancreatic cancer that has spread to other parts of the body.

Estudio en el que se evalúan nab-paclitaxel y gemcitabina, con o sin olaratumab, como tratamiento del cáncer de páncreas que se ha extendido a otras partes del cuerpo.

A.4.1

Sponsor's protocol code number

I5B-MC-JGDP

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	Lilly 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	Eli Lilly and Company
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	Lilly S.A.
B.5.2	Functional name of contact point	Ana Isabel Almansa
B.5.3	Address:
B.5.3.1	Street Address	Avenida de la Industria 30
B.5.3.2	Town/ city	Alcobendas/Madrid
B.5.3.3	Post code	28108
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34916633455
B.5.5	Fax number	+34916633481
B.5.6	E-mail	almansa_ana_isabel@lilly.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	Yes
D.2.1.1.1	Trade name	Lartruvo
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V
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	olaratumab
D.3.2	Product code	LY3012207
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	olaratumab
D.3.9.1	CAS number	1024603-93-7
D.3.9.3	Other descriptive name	OLARATUMAB
D.3.9.4	EV Substance Code	SUB67904
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	10
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

First-Line Metastatic Pancreatic Cancer

Cáncer de páncreas metastásico en primera línea de tratamiento

E.1.1.1

Medical condition in easily understood language

Pancreatic cancer that has spread to other areas of the body.

Cáncer de páncreas que se ha extendido a otras partes del cuerpo.

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10073364
E.1.2	Term	Ductal adenocarcinoma of pancreas
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

Phase Ib: To determine a recommended Phase 2 dose of olaratumab in combination with nab-paclitaxel and gemcitabine

Phase II: To compare the efficacy of olaratumab plus nab-paclitaxel and gemcitabine with placebo plus gemcitabine and nab-paclitaxel

Fase Ib: Determinar la dosis recomendada de olaratumab para la fase 2, en combinación con nab-paclitaxel y gemcitabina
Fase 2: Comparar la eficacia de olaratumab junto con nab-paclitaxel y gemcitabina con la del placebo administrado con nab-paclitaxel y gemcitabina

E.2.2

Secondary objectives of the trial

Phase 1b
 to characterize the safety and toxicity profile of
olaratumab plus nab-paclitaxel and gemcitabine
 to evaluate the PK and immunogenicity of olaratumab
plus nab-paclitaxel and gemcitabine
 to document the antitumor activity observed with
olaratumab plus nab-paclitaxel and gemcitabine
Phase 2
 to assess time-to-event variables
 to document the antitumor activity observed with
olaratumab plus nab-paclitaxel and gemcitabine
 to assess PROs: pain, HRQoL, and health status
 to determine safety and tolerability of olaratumab in
combination with nab-paclitaxel and gemcitabine
 to assess the PK and immunogenicity

Fase Ib
• Caracterizar el perfil de seguridad y toxicidad de olaratumab cuando se administra con nab-paclitaxel y gemcitabina
• Evaluar la FC y la inmunogenicidad de olaratumab cuando se administra con nab-paclitaxel y gemcitabina
• Documentar la actividad antineoplásica que se observa cuando se administra olaratumab junto con nab-paclitaxel y gemcitabina
Fase 2
• Evaluar las variables del “tiempo transcurrido hasta el evento”
• Documentar la actividad antineoplásica que se observa cuando se administra olaratumab junto con nab-paclitaxel y gemcitabina
• Evaluar los RPP: dolor, CdVRS y el estado de salud
• Determinar la seguridad y la tolerabilidad de olaratumab cuando se administra en combinación con nab-paclitaxel y gemcitabina
• Evaluar la FC y la inmunogenicidad

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

[1] have histological or cytological diagnosis of adenocarcinoma of the exocrine
pancreas that is metastatic (Stage IV) and not amenable to resection with
curative intent and be patients for whom nab-paclitaxel-gemcitabine therapy is
considered by the investigator to be an appropriate treatment. Patients with
previous radical surgery for pancreatic cancer are eligible after progression is
documented.
[2] if present, clinically significant or symptomatic amounts of ascites should be
drained prior to Day 1
[3] have sufficient available material from an archived formalin-fixed paraffinembedded
(FFPE) tumor tissue for biomarker-related studies. If such tissue is
not available, a newly obtained core or excisional biopsy of a tumor lesion
must be performed in the Phase 2 portion of the study.
[4] The patient has measurable or nonmeasurable but evaluable disease as defined
by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1,
Eisenhauer et al. 2009). Tumors within a previously irradiated field will be
designated as “nontarget” lesions unless progression is documented or a
biopsy is obtained to confirm persistence at least 90 days following
completion of radiotherapy.
[5] have had no prior systemic treatment for metastatic disease. Prior adjuvant or
neo-adjuvant chemotherapy or radiochemotherapy use of gemcitabine
monotherapy is allowed if completed ≥ 3 months prior to enrollment. Prior
treatment with 5-Fluorouracil (5-FU) administered as a radiation sensitizer in
the adjuvant setting is allowed, if completed ≥3 months prior to enrollment
and no lingering toxicities are present.
[6] prior radiation therapy for treatment of cancer is allowed to <25% of the bone
marrow (Cristy and Eckerman 1987). Patients must have recovered from the
acute toxic effects of their treatment prior to study enrollment. Prior
radiotherapy must be completed ≥3 months prior to study entry.
[7] have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology
Group (ECOG) scale (Oken et al. 1982)
[8] have discontinued all previous treatments for cancer and recovered from the
acute effects of therapy. Patients must have discontinued from previous
treatments (radiotherapy/
[9] have adequate organ function
[10] are at least 18 years old at the time of screening/randomization
[11] If male, the patient is sterile (including vasectomy) or agrees to use an
effective method of birth control. Refer to Appendix 1 for definitions of
effective method
[12] If female:
o is not of childbearing potential due to surgical sterilization confirmed by
medical history (at least 6 weeks post-surgical bilateral oophorectomy with or
without hysterectomy or tubal ligation) or menopause
o is of childbearing potential, has a negative serum or urine pregnancy test
within 72 hours prior to the first dose of study treatment, agrees to use a
highly effective method of birth control during the study and for up to
120 days following the last dose of the study treatment, and is not
breastfeeding. If the urine test is positive or cannot be confirmed as negative,
a serum pregnancy test will be required. Refer to Appendix 1 for definitions
of effective method of contraception and highly effective method of
contraception.
[13] have given written informed consent/assent prior to any study-specific
procedures
[14] has a life expectancy of at least 3 months in the opinion of the investigators

[1] Diagnóstico histológico o citológico de adenocarcinoma del páncreas exocrino, metastásico (estadio IV) y no tributario de tratamiento curativo mediante resección. Por otra parte, que el investigador considere que el tratamiento con nab-paclitaxel y gemcitabina es adecuado.
Los pacientes que se hayan sometido anteriormente a cirugía radical para el cáncer de páncreas podrán considerarse idóneos una vez que se haya documentado la progresión de la enfermedad.
[2] En caso de que el paciente presente una cantidad clínicamente importante o sintomática de ascitis, debe drenarse antes del día 1.
[3] Contar con muestra suficiente de tejido tumoral conservado (fijado en formol e incluido en parafina [FFIP]) para analizar los biomarcadores. Si no se dispone de tejido, en la parte del estudio de fase 2 deberá realizarse una nueva biopsia con aguja gruesa o por escisión de una lesión tumoral.
[4] Enfermedad mensurable, o no mensurable pero evaluable, de acuerdo con los Criterios de evaluación de la respuesta en los tumores sólidos, (RECIST 1.1, Eisenhauer et al. 2009). Los tumores que se encuentren en una zona a la que se hubiera irradiado anteriormente se denominarán lesiones “no diana”, a menos que se documente la progresión de la enfermedad o se realice una biopsia para confirmar la persistencia de la enfermedad, al menos 90 días después de haber completado la radioterapia.
[5] No haber recibido anteriormente tratamiento sistémico para el cáncer metastásico. Se permite que el paciente haya recibido quimioterapia o radioquimioterapia adyuvante o neoadyuvante con gemcitabina en monoterapia, siempre que el tratamiento haya finalizado ≥ 3 meses antes del reclutamiento. Se permite que el paciente haya recibido tratamiento adyuvante con 5-fluorouracilo (5-FU) como sensibilizante a la radiación, si el tratamiento ha finalizado ≥ 3 meses antes del reclutamiento y el paciente no presenta toxicidad asociada.
[6] Se permite que el paciente haya recibido tratamiento radioterápico antineoplásico, siempre que hubiera afectado a menos del 25 % de la médula ósea (Cristy y Eckerman, 1987). Para que se les pueda reclutar en el estudio, los pacientes deben haberse recuperado de los efectos tóxicos inmediatos del tratamiento. La radioterapia previa debe haber finalizado ≥ 3 meses antes de la inclusión en el estudio.
[7] Categoría funcional (CF) de 0 o 1 en la escala del Eastern Cooperative Oncology Group (ECOG) (Oken et al. 1982).
[8] Haber dejado de recibir definitivamente todos los tratamientos antineoplásicos anteriores y haberse recuperado de los efectos inmediatos del tratamiento. Los pacientes deberán haber dejado de recibir definitivamente todos los tratamientos anteriores (radioterapia/
[9] Función orgánica aceptable.
[10] Tener al menos 18 años en el momento de la selección/aleatorización
[11] Los varones deben ser estériles (lo que incluye haberse sometido a una vasectomía) o estar de acuerdo en utilizar un método anticonceptivo eficaz. En el anexo 1 se define qué se entiende por “método eficaz”.
[12] Las mujeres:
• no son fértiles, al estar esterilizadas quirúrgicamente (desde hace al menos 6 semanas, mediante ovariectomía bilateral, con o sin histerectomía, o ligadura de trompas) y siempre que se haya confirmado en los antecedentes médicos o por la presencia de menopausia;
• son fértiles, pero presentan resultados negativos en una prueba de embarazo en suero u orina, en el transcurso de las 72 horas anteriores a la primera dosis del tratamiento del estudio, están de acuerdo en utilizar un método anticonceptivo muy eficaz durante el estudio y hasta 120 días después de la última dosis del tratamiento del estudio, y no se encuentran en período de lactancia. Si los resultados de la prueba en orina son positivos o no se puede confirmar que sean negativos, deberá realizarse una prueba de embarazo en suero. En el anexo 1 se indica qué se entiende por un método anticonceptivo eficaz o muy eficaz.
[13] Haber proporcionado el consentimiento/asentimiento informado por escrito antes de la realización de cualquier procedimiento específico del estudio.
[14] Esperanza de vida de al menos 3 meses, de acuerdo con el criterio del investigador

E.4

Principal exclusion criteria

[15] have received first line treatment for metastatic pancreatic cancer.
[16] have received prior treatment with FOLFOX or FOLFIRINOX.
[17] have a serious concomitant systemic disorder (for example, active infection
including human immunodeficiency virus, or cardiac disease) or other
condition that, in the opinion of the investigator, would compromise the
patient’s ability to adhere to the protocol
[18] have known central nervous system (CNS) malignancy or metastasis
(screening not required)
[19] have current hematologic malignancies, acute or chronic leukemia
[20] have participated within the last 30 days in a clinical trial involving an
investigational product. If the previous investigational product has a long
half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
[21] are women with a positive pregnancy test or who are lactating
[22] have endocrine pancreatic tumors or ampullary cancer
[23] are currently enrolled in a clinical trial involving an investigational product or
any other type of medical research judged not to be scientifically or medically
compatible with this study
[24] have a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ), unless in complete remission and off all therapy for that
disease for a minimum of 1 year
[25] have known allergy to nab-paclitaxel, gemcitabine, or any ingredient of
olaratumab, nab-paclitaxel, or gemcitabine formulations

[15] Haber recibido tratamiento de primera línea para el cáncer de páncreas metastásico.
[16] Haber recibido anteriormente tratamiento con FOLFOX o FOLFIRINOX.
[17] Presentar un trastorno sistémico concomitante grave (por ejemplo, una infección activa, incluido el virus de la inmunodeficiencia humana, o una cardiopatía) u otra enfermedad que, en opinión del investigador, podría afectar su capacidad para cumplir el protocolo.
[18] Presentar neoplasias malignas o metástasis en el sistema nervioso central (SNC) (no se necesitan pruebas de detección).
[19] Presentar en la actualidad neoplasias hematológicas malignas o leucemia crónica o aguda.
[20] Haber participado en el transcurso de los 30 últimos días en un ensayo clínico en el que se administrara un producto en fase de investigación. En caso de que el producto en fase de investigación que se hubiera administrado tenga una semivida prolongada, deberán haber transcurrido 3 meses o 5 semividas (lo que sea mayor).
[21] Mujeres con resultado positivo en una prueba de embarazo o que se encuentren en período de lactancia.
[22] Presentar tumores endocrinos del páncreas o cáncer ampular.
[23] Participar en la actualidad en un ensayo clínico en el que se administre un producto en fase de investigación o en cualquier otro tipo de investigación médica que se considere incompatible con el estudio desde un punto de vista científico o médico.
[24] Presentar antecedentes de cualquier otro cáncer (excepto cáncer de piel no melanomatoso o carcinoma localizado), salvo si se encuentra en remisión completa desde hace al menos 1 año, sin ningún tipo de tratamiento.
[25] Presentar alergia a nab-paclitaxel, gemcitabina o a cualquier ingrediente de las formas farmacéuticas de olaratumab, nab-paclitaxel o gemcitabina.

E.5 End points

E.5.1

Primary end point(s)

Phase 1b
 DLTs
 Safety (including but not limited to) TEAEs, SAEs,
and clinical laboratory abnormalities
Phase 2
 OS

Fase 1b
• TLD
• Seguridad (entre otros parámetros): AAST, AAG y resultados anómalos en los análisis clínicos
Fase 2
• SG

E.5.1.1

Timepoint(s) of evaluation of this end point

DLT-evaluable Population: The DLT-evaluable population will include all enrolled patients
who complete Cycle 1 or discontinue due to a DLT prior to completing Cycle 1 treatment.
Safety population: All enrolled patients who receive any quantity of study treatment, regardless
of their eligibility for the study, will be included in the safety analysis. Safety evaluation will be
performed based on the actual initial therapy a patient has received, regardless of any other
cohort to which he or she was assigned.

The primary analysis of OS will be performed when a
minimum of 113 OS events have been observed.

Población evaluable para determinar las TLD: incluirá a todos los pacientes reclutados que completen el ciclo 1 o que dejen de recibir definitivamente el tratamiento antes de completar el ciclo 1 a causa de una TLD.

Población para el análisis de la seguridad: incluirá a todos los pacientes reclutados que reciban cualquier cantidad del tratamiento del estudio, independientemente de su idoneidad para participar en el estudio.
La evaluación de la seguridad se realizará en función del tratamiento inicial que el paciente haya recibido realmente, independientemente de la cohorte a la que se le hubiera asignado.
El análisis principal de la SG se llevará a cabo cuando se hayan observado al menos 113 eventos de SG.

E.5.2

Secondary end point(s)

Phase 1b
 Safety monitoring, including TEAEs, SAE, and deaths
 Minimum serum/plasma concentration of olaratumab
plus nab-paclitaxel and gemcitabine
 OS, PFS, ORR, and DoR
Phase 2
 PFS, DoR
 ORR
 mBPI-sf, EORTC-QLQ-C30, and EQ-5D-5L
 TEAEs, AESI, SAEs, clinical laboratory tests, vital
signs, physical examinations, hospitalization, and
deaths
 Minimum serum/plasma concentration of olaratumab
plus nab-paclitaxel and gemcitabine

Fase 1b
• Seguimiento de la seguridad, entre otros parámetros, los AAST, los AAG y las muertes
• Concentración plasmática/sérica mínima de olaratumab cuando se administra con nab-paclitaxel y gemcitabina
• SG, SSP, TRO y DdR
Fase 2
• SSP, DdR
• TRO
• mBPI-sf, EORTC-QLQ-C30 y EQ-5D-5L
• AAST, AAIE, AAG, análisis clínicos, constantes vitales, exploraciones físicas, hospitalizaciones y muertes
• Concentración plasmática/sérica mínima de olaratumab cuando se administra con nab-paclitaxel y gemcitabine

E.5.2.1

Timepoint(s) of evaluation of this end point

An interim analysis that includes both safety and efficacy will be conducted. The analysis will
occur after at least 70 OS events have been observed among Phase 2 patients. The interim
analysis will not be used for purposes of formally testing any efficacy hypotheses, but
descriptive efficacy results will be considered in order to decide whether or not a separate
Phase 3 trial evaluating olaratumab in combination with nab-paclitaxel and gemcitabine should
be initiated.

Se realizará un análisis provisional de la seguridad y la eficacia. El análisis se realizará una vez que se hayan observado 70 eventos de SSP en los pacientes de la fase 2. El análisis provisional no se utilizará para contrastar formalmente ninguna de las hipótesis relativas a la eficacia, sino que se considerarán los resultados descriptivos de la eficacia a la hora de decidir si debe comenzarse otro ensayo de fase 3 para evaluar la administración de olaratumab en combinación con nab-paclitaxel y gemcitabina.

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

E.6.7

Pharmacodynamic

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Phase 1b

Fase 1b

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

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Phase 1b of the study is open label. Phase 2 is double-blind

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.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Germany

Italy

Spain

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

LVLS

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:

112

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

186

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)

Patients without disease progression may continue to receive treatment until the development of unacceptable toxicity, death, or other discontinuation criteria are met . There are no study specific treatment plans for patients that discontinue from the study,

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

2017-07-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-23

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials