Clinical Trials Register

Summary
EudraCT Number:	2018-001028-21
Sponsor's Protocol Code Number:	D6070C00005
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-08-07
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

2018-001028-21

A.3

Full title of the trial

A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma

Estudio de fase Ib/II para evaluar la seguridad, farmacocinética y actividad clínica de oleclumab (MEDI9447) con o sin durvalumab en combinación con quimioterapia en pacientes con adenocarcinoma ductal pancreático metastásico

A.3.1

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

A Study of Oleclumab (MEDI9447) with or without Durvalumab Combined with Chemotherapy in Subjects with Pancreatic Cancer

Estudio de oleclumab (MEDI9447) con o sin durvalumab en combinación con quimioterapia en pacientes con cáncer de páncreas

A.4.1

Sponsor's protocol code number

D6070C00005

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	MedImmune, LLC
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	MedImmune, LLC
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	MedImmune LLC
B.5.2	Functional name of contact point	Clinical Trial Enquiries
B.5.3	Address:
B.5.3.1	Street Address	One MedImmune Way
B.5.3.2	Town/ city	Gaithersburg
B.5.3.3	Post code	20878
B.5.3.4	Country	United States
B.5.6	E-mail	clinicaltrialenquiries@medimmune.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	Oleclumab
D.3.2	Product code	MEDI9447
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	not assigned
D.3.9.1	CAS number	not assigned
D.3.9.2	Current sponsor code	MEDI9447
D.3.9.3	Other descriptive name	Oleclumab
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	50
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	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	Durvalumab
D.3.2	Product code	MEDI4736
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
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	50
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: 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.2.5	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	gemcitabine
D.3.4	Pharmaceutical form
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	gemcitabine
D.3.9.3	Other descriptive name	gemcitabine
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.2.5	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	nab-paclitaxel
D.3.4	Pharmaceutical form
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	nab-paclitaxel
D.3.9.3	Other descriptive name	nab-paclitaxel
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: 5
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.2.5	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	mFOLFOX
D.3.4	Pharmaceutical form
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	leucovorin
D.3.9.3	Other descriptive name	folinic acid
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	5-FU
D.3.9.3	Other descriptive name	5-FU
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	oxaliplatin
D.3.9.3	Other descriptive name	oxaliplatin
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

Pancreatic Ductal Adenocarcinoma

Adenocarcinoma Ductal Pancreatico

E.1.1.1

Medical condition in easily understood language

Pancreatic Cancer

Cancer Pancreatico

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	LLT
E.1.2	Classification code	10051971
E.1.2	Term	Pancreatic adenocarcinoma
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 assess the safety and tolerability of oleclumab plus durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel administered in subjects with 1L metastatic PDAC. To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with mFOLFOX compared to mFOLFOX administered in subjects with 2L metastatic PDAC.

Evaluar la seguridad y tolerabilidad de oleclumab más durvalumab en combinación con quimioterapia administrados a pacientes con ACDP metastásico.
Evaluar la actividad antitumoral preliminar de oleclumab con o sin durvalumab en combinación con gemcitabina y nab-paclitaxel en comparación con gemcitabina y nab-paclitaxel administrados a pacientes con ACDP metastásico en primera línea (1L).
Evaluar la actividad antitumoral preliminar de oleclumab con o sin durvalumab en combinación con mFOLFOX en comparación con mFOLFOX administrados a pacientes con ACDP metastásico en segunda línea (2L).

E.2.2

Secondary objectives of the trial

To assess the safety and tolerability of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. To evaluate the preliminary
antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with 1L metastatic PDAC and in subjects with 2L metastatic PDAC.
To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy compared to chemotherapy alone in the population defined by CD73
expression.
To determine the PK profile of oleclumab and durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC.

Evaluar la seguridad y tolerabilidad de oleclumab con o sin durvalumab en combinación con quimioterapia administrados a pacientes con ACDP metastásico.
Evaluar la actividad antitumoral preliminar de oleclumab con o sin durvalumab en combinación con quimioterapia administrados a pacientes con ACDP metastásico en 1L y a pacientes con ACDP metastásico en 2L.
Evaluar la actividad antitumoral preliminar de oleclumab con o sin durvalumab en combinación con quimioterapia en comparación con quimioterapia sola en la población definida por la expresión de CD73.
Determinar el perfil FC de oleclumab y durvalumab en combinación con quimioterapia administrados a pacientes con ACDP metastásico.
Consulte el protocolo del estudio para obtener información detallada sobre los objetivos secundarios.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age ≥ 18
2. Written and signed informed consent must be obtained
3. ECOG Performance Status 0 or 1
4. Weight ≥ 35 kg
5. Subjects must have histologically or cytologically confirmed pancreatic adenocarcinoma:
Cohort A: Subjects with previously untreated metastatic pancreatic adenocarcinoma (1 line metastatic disease) not previously treated with systemic therapies.
Cohort B: Subjects with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2 line metastatic adenocarcinoma
6. Subjects must have at least 1 measurable lesion according to RECIST v1.1
7. All subjects must consent to providing archival tumor specimens

1. Edad ≥18 años.
2. Se debe obtener el consentimiento informado firmado y por escrito.
3. Estado funcional según la escala del Grupo Oncológico Cooperativo de la Costa Este (ECOG) de 0 o 1.
4. Peso ≥35 kg.
5. Los pacientes deben tener un diagnóstico confirmado de forma histológica o citológica de adenocarcinoma pancreático:
Cohorte A: pacientes con adenocarcinoma pancreático metastásico sin tratamiento previo (enfermedad metastásica en 1L) que no hayan recibido tratamientos sistémicos previos.
Cohorte B: pacientes con adenocarcinoma pancreático metastásico tratado previamente con quimioterapia a base de gemcitabina (sin exposición a 5 FU, capecitabina u oxaliplatino); adenocarcinoma metastásico en 2L.
6. Los pacientes deben presentar al menos 1 lesión medible según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST) v1.1.
7. Todos los pacientes deben otorgar su consentimiento para proporcionar muestras tumorales de archivo.

E.4

Principal exclusion criteria

1. Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.
2. Prior receipt of any immune-related therapy
3. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed
4. Subjects with a history of venous thrombosis within the past 3 months
5. Subjects with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
6. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
7. Other invasive malignancy within 2 years.
8. Any history of leptomeningeal disease or cord compression.
9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose

1. Haber recibido cualquier tratamiento antineoplásico convencional o en investigación en los 21 días previos a la administración de la primera dosis programada del tratamiento del estudio o radioterapia paliativa en los 14 días previos a la administración de la primera dosis programada del tratamiento del estudio.
2. Haber recibido cualquier tratamiento previo relacionado con el sistema inmunitario.
3. Inscripción simultánea en otro estudio clínico terapéutico. Se permitirá la inscripción en estudios observacionales.
4. Pacientes con antecedentes de flebotrombosis en los últimos 3 meses.
5. Pacientes con antecedentes de infarto de miocardio, accidente isquémico transitorio o accidente cerebrovascular en los 3 meses previos al inicio del tratamiento.
6. Trastornos autoinmunitarios o inflamatorios activos o previamente documentados en los 3 años previos al inicio del tratamiento.
7. Otras neoplasias malignas invasivas en los 2 años previos.
8. Cualquier antecedente de carcinomatosis leptomeníngea o compresión medular.
9. Uso actual o previo de inmunodepresores en los 14 días previos a la administración de la primera dosis.

E.5 End points

E.5.1

Primary end point(s)

1. Incidence of adverse events as a measure of safety of oleclumab plus durvalumab in combination with chemotherapy in dose escalation as assessed by the presence of adverse events (AEs), serious adverse events (SAEs), dose limiting toxicities (DLTs) and clinically meaningful changes from baseline of laboratory and physical assessments

2. Objective response rate as a measure of antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy in dose expansion according to RECIST v1.1

1. Incidencia de acontecimientos adversos como medida de la seguridad de oleclumab más durvalumab en combinación con quimioterapia durante la parte de aumento escalonado de la dosis, mediante la evaluación de la presencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG), toxicidades limitantes de la dosis (TLD) y cambios clínicamente significativos respecto al inicio en las evaluaciones clínicas y físicas.
2. Tasa de respuesta objetiva como medida de la actividad antitumoral de oleclumab con o sin durvalumab en combinación con quimioterapia durante la parte de ampliación de la dosis conforme a los criterios RECIST v1.1.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Safety assessment from time of informed consent through 12 weeks after last dose of investigational product
2. Objective response rates during treatment through study completion, about 2 years after the last subject dosed

1. Evaluación de la seguridad desde el momento de la obtención del consentimiento informado hasta 12 semanas después de la última dosis del producto en investigación.
2. Tasas de respuesta objetiva durante el tratamiento hasta la finalización del estudio, aproximadamente 2 años después de la administración del tratamiento al último paciente.

E.5.2

Secondary end point(s)

1. Incidence of adverse events (AEs), serious adverse events (SAEs), and clinically meaningful changes from baseline of laboratory and physical assessments in dose expansion
2. Objective response rate (OR) and disease control (DC) according to RECIST v1.1 in dose escalation
3. Overall Survival (OS); Progression Free Survival (PFS), Duration of Response (DoR), and Disease Control (DC), defined as complete response (CR), partial response (PR) or stable disease (SD) according to RECIST v1.1 in dose expansion
4. Overall Survival (OS); Objective Response (OR) and Progression-Free Survival (PFS) according to RECIST v1.1 by CD73 expression at baseline
5. Immunogenicity. Development of detectable anti-drug antibody(ADA) to oleclumab (MEDI9447) and durvalumab
6. Pharmacokinetic. Measure of serum Oleclumab (MEDI9447), durvalumab and selected chemotherapies and /or their metabolites

1. Incidencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG), así como cambios clínicamente significativos respecto al inicio en las evaluaciones clínicas y físicas durante la parte de ampliación de la dosis.
2. Tasa de respuesta objetiva (RO) y control de la enfermedad (CE) conforme a los criterios RECIST v1.1 durante la parte de aumento escalonado de la dosis.
3. Supervivencia global (SG); supervivencia sin progresión (SSP), duración de la respuesta (DdR) y control de la enfermedad (CE), definida como una respuesta completa (RC), respuesta parcial (RP) o enfermedad estable (EE) conforme a los criterios RECIST v1.1 durante la parte de ampliación de la dosis.
4. Supervivencia global (SG); respuesta objetiva (RO) y supervivencia sin progresión (SSP) conforme a los criterios RECIST v1.1 por la expresión de CD73 en el momento basal.
5. Inmunogenicidad. Desarrollo de anticuerpos antifármaco (AAF) detectables para oleclumab (MEDI9447) y durvalumab.
6. Farmacocinética. Niveles séricos de oleclumab (MEDI9447), durvalumab y de quimioterapias seleccionadas y/o sus metabolitos.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. From time of informed consent through 12 weeks after last dose of investigational product
2. During treatment through study completion, about 2 years after the last subject dosed
3. During treatment through study completion, about 2 years after the last subject dosed
4. From time of screening through study completion, about 2 years after the last subject dosed
5. From start of treatment through 12 weeks post last dose of investigational product
6. During treatment through 12 weeks post last dose of investigational product and through the first 12 weeks of treatment for chemotherapies

1. Desde el momento de la obtención del CI hasta 12 semanas después de la última dosis del producto en investigación.
2. Durante el tratamiento (tto) hasta la finalización del estudio, aprox. 2 años después de la administración del tto al último paciente.
3. Durante el tto hasta la finalización del estudio, aprox. 2 años después de la administración del tto al último paciente.
4. Desde el momento de la selección hasta la finalización del estudio, aproximadamente 2 años después de la administración del tto al último paciente.
5. Desde el inicio del tto hasta 12 semanas después de la última dosis del producto en investigación.
6. Durante el tto hasta 12 semanas después de la última dosis del producto en investigación y durante las primeras 12 semanas de tto para las quimioterapias.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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 Ib: Safety and pharmacokinetics

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

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

gemcitabine, nab-paclitaxel, and mFOLFOX

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

Norway

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

Last subject last visit

Última visita del último paciente.

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

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:

122

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

204

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)

None

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

2018-11-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-12

P. End of Trial
P.	End of Trial Status	Ongoing

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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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