Clinical Trials Register

Summary
EudraCT Number:	2021-000317-17
Sponsor's Protocol Code Number:	ICI20-00047
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:	2021-06-11
Trial 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

2021-000317-17

A.3

Full title of the trial

Survival analysis after neoadjuvant therapy in patients with resectable pancreatic cancer and risk factors

ANÁLISIS DE SUPERVIVENCIA TRAS NEOADYUVANCIA EN CÁNCER DE PÁNCREAS RESECABLE CON FACTORES DE RIESGO

A.3.1

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

Survival analysis after pre-surgical therapy in patients with resectable pancreatic cancer and risk factors

ANÁLISIS DE SUPERVIVENCIA TRAS TRATAMIENTO ANTES DE LA CIRUGÍA EN CÁNCER DE PÁNCREAS RESECABLE CON FACTORES DE RIESGO

A.4.1

Sponsor's protocol code number

ICI20-00047

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	Fundación para la Gestión de la Investigación Biomédica de Cádiz-INIBICA
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Instituto de Salud Carlos III
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundación para la Gestión de la Investigación Biomédica de Cádiz-INIBICA
B.5.2	Functional name of contact point	Laura Quintana López
B.5.3	Address:
B.5.3.1	Street Address	Avda Ana de Viya
B.5.3.2	Town/ city	Cádiz
B.5.3.3	Post code	11009
B.5.3.4	Country	Spain
B.5.6	E-mail	laura.quintana@inibica.es

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.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Irinotecan
D.3.4	Pharmaceutical form	Concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IRINOTECAN
D.3.9.1	CAS number	97682-44-5
D.3.9.4	EV Substance Code	SUB08295MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fluorouracil
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	fluoroulacil
D.3.9.3	Other descriptive name	FLUOROURACIL
D.3.9.4	EV Substance Code	SUB07721MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2400
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: 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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Oxaliplatin
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	OXALIPLATIN
D.3.9.1	CAS number	61825-94-3
D.3.9.4	EV Substance Code	SUB09490MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	85
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	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.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	calcium folinate
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	CALCIUM FOLINATE
D.3.9.3	Other descriptive name	CALCIUM FOLINATE
D.3.9.4	EV Substance Code	SUB06052MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
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

Resectable pancreatic cancer and risk factors

Cáncer de pancreas resecable con factores de riesgo

E.1.1.1

Medical condition in easily understood language

Non-operable pancreatic cancer plus other conditions that increase the possibility to adquire a disease

Cancer de pancreas no operable mas otras condiciones que aumenten la posibilidad de adquirir una enfermedad

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10033608
E.1.2	Term	Pancreatic cancer resectable
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 overall survival in patients treated with neoadyuvant chemotherapy before surgery-resection and adyuvant chemotherapy vs patients traeted only with adjuvant chemotherapy after surgery-resection

Evaluar la supervivencia global en pacientes tratados con quimioterapia neoadyuvante antes de la resección quirúrgica y compararla frente a la supervivencia en pacientes tratados solo con tratamiento adyuvante tras la resección quirúrgica.

E.2.2

Secondary objectives of the trial

To assess in both patients (experimental vs control arms):
- Progression free survival
- Number of completed cycles fo chemotherapy
- Local and metastatic recurrence
- Post-surgical morbidity
- Resection rate R0
- Safety of the neoadyuvant chemotherapy

Evaluar en ambas ramas (experimentar vs control):
- supervivencia libre de enfermedad
- ciclos completados.
- recaídas locales y metastásicas
- morbimortalidad post-quirúrgica
- tasas de resección R0
- seguridad del tratamiento neoadyuvante

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients diagnosed with resectable pancreatic adenocarcinoma plus risk factors
2. Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration (FNA) performed by Echoendoscopy.
3. Patients who have not received prior therapy for pancreatic cancer.
4. Biliary drainage prior to neoadjuvant treatment.
5. Age> 18 years and <70 years.
6. No history of cerebrovascular accident (CVA) or myocardial infarction (MI) in 6 months prior to neoadjuvant treatment.
7. Women of childbearing potential and sexually active men must agree to the use of appropriate contraceptive methods (hormonal, barrier, or abstinence) prior to study enrollment and during study participation.
8. Patients should have normal organs and spinal function.
9. Ability to understand, and willingness to sign a written informed consent document.

1. Pacientes diagnosticados de adenocarcinoma de páncreas resecable y con factores de riesgo
2. Diagnóstico histológico de adenocarcinoma de páncreas mediante punción aspiración aguja fina (PAAF) realizada por ecoendoscopia.
3. Pacientes que no han recibido terapia previa para el cáncer de páncreas.
4. Drenaje biliar previo a la neoadyuvancia.
5. Edad > 18 años y < 70 años.
6. Sin antecedentes de accidente cerebro vascular (ACV) ni infarto de miocardio (IM) en 6 meses previos al tratamiento neoadyuvante.
7. Las mujeres en edad fértil y los hombres activos sexualmente deben aceptar el uso de métodos anticonceptivos adecuados (método anticonceptivo hormonal, de barrera o abstinencia) antes de la inclusión en el estudio, y durante la participación en el mismo.
8. Los pacientes deben tener una función normal de órganos y médula.
9. Capacidad para comprender, y voluntad de firmar un documento de consentimiento informado por escrito.

E.4

Principal exclusion criteria

1. Patients with resectable pancreatic adenocarcinoma without risk factors.
2. Patients with borderline pancreatic adenocarcinoma.
3. Patients with locally advanced pancreatic adenocarcinoma.
4. Patients with metastatic adenocarcinoma of the pancreas.
5. Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
6. Pathological subtypes other than adenocarcinoma.
7. Patients included in a clinical trial in a period of 6 months prior to inclusion in this study.
8. A past history of allergic reaction attributed to 5-FU, leucovorin, Irinotecan or Oxaliplatin or to compounds of similar chemical or biological composition.
9. Uncontrolled breakthrough disease.
10. Patients with HIV, HBV and HCV positive and currently under antiretroviral therapy.
11. Other active malignancies
12. Pre-existing neuropathy, grade > 1.
13. Inflammatory bowel disease that is not controlled, or under current active therapy.

1. Pacientes con adenocarcinoma de páncreas resecable sin factores de riesgo.
2. Pacientes con adenocarcinoma de páncreas borderline.
3. Pacientes con adenocarcinoma de páncreas localmente avanzado.
4. Pacientes con adenocarcinoma de páncreas metastásico.
5. Pacientes que hayan recibido quimioterapia o radioterapia previa para el adenocarcinoma de páncreas.
6. Subtipos patológicos distintos del adenocarcinoma.
7. Pacientes incluidos en un ensayo clínico que conlleve la toma de medicamento en un período de 6 meses anteriores a la inclusión en este estudio.
8. Antecedentes de reacción alérgica atribuidas a 5-FU, leucovorina, Irinotecan u Oxaliplatino o a compuestos de composicion quimica o biológica similar.
9. Enfermedad intercurrente no controlada.
10. Los pacientes VHI, VHB y VHC positivos y en terapia antiretroviral combinada en la actualidad.
11. Otras neoplasias activas
12. Neuropatia preexistente, mayor a grado 1.
13. Enfermedad inflamatoria intestinal que no está controlada, o se encuentre en tratamiento activo actual.

E.5 End points

E.5.1

Primary end point(s)

Period (weeks) until death

Tiempo (semanas) hasta exitus

E.5.1.1

Timepoint(s) of evaluation of this end point

Not applicable, since time is the endpoint of evaluation

No aplica, ya que el tiempo es la variable a evaluar

E.5.2

Secondary end point(s)

- Period (weeks) until recurrence disease (local or metastatic recurrence)
- Number of completed chemotherapy cycles
- development and location of new lesions
- Number and data about post-surgical events (if any)
- Resection rate RO
- Number and data about adverse events.

- Tiempo hasta recaída de la enfermedad, y especificación si la recaída es local o metastásica.
- Número de ciclos completados.
- Aparición de lesiones nuevas locales y lesiones metastásicas
- Número y tipos de eventos post-quirúrgicos (si hubiere).
- Tasas de resección R0.
- Número y naturaleza de eventos adversos

E.5.2.1

Timepoint(s) of evaluation of this end point

These data will be recordered along the follow up period of patients (since cycle 1- day 1 until the end of the follow up period)

Estos datos se recogerán a lo largo de todo el periodo de seguimiento a los pacientes (desde ciclo 1-dia 1 hasta el fin del período de seguimiento)

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

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)

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

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

LPLV

UPUV

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

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:

116

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

116

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

116

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)

The standard of care treatment on every site

El tratamiento estándar en cada centro

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

2021-08-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-30

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

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