Clinical Trials Register

Summary
EudraCT Number:	2017-003621-15
Sponsor's Protocol Code Number:	CENTER
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-003621-15

A.3

Full title of the trial

A Phase II study of a Combination of Eribulin and capecitabiNe in second line Treatment after the failure of gemcitabine/abraxane first line in advanced pancreatic cancer

Studio di Fase II di eribulina in combinazione con capecitabina per il trattamento di seconda linea in pazienti affetti da carcinoma pancreatico avanzato dopo fallimento di terapia di prima linea con gemcitabina/abraxane.

A.3.1

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

A Phase II study of a Combination of Eribulin and capecitabiNe in second line Treatment after the failure of gemcitabine/abraxane first line in advanced pancreatic cancer

A.3.2

Name or abbreviated title of the trial where available

Phase II study, single-arm with eribulin + capecitabine after gemcitabine / abraxane failure in pati

Studio di Fase II a singolo braccio con eribulina + capecitabina dopo fallimento di gemcitabina/abra

A.4.1

Sponsor's protocol code number

CENTER

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	AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
B.1.3.4	Country	Italy
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	EISAI srl
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Servizio Formazione, Ricerca e Innovazione
B.5.2	Functional name of contact point	Clinical Trial Quality Team
B.5.3	Address:
B.5.3.1	Street Address	AOU di Modena Via del Pozzo 71
B.5.3.2	Town/ city	Modena
B.5.3.3	Post code	41124
B.5.3.4	Country	Italy
B.5.4	Telephone number	0594225868
B.5.5	Fax number	0594224369
B.5.6	E-mail	ricercainnovazione@policlinico.mo.it

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	HALAVEN - 0.44MG/ML - SOLUZIONE INIETTABILE - USO ENDOVENOSO - FLACONCINO(VETRO) 2ML 6 FLACONCINI
D.2.1.1.2	Name of the Marketing Authorisation holder	EISAI LTD
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	HALAVEN
D.3.2	Product code	[-]
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.3.9.2	Current sponsor code	-
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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.2.1.1.1	Trade name	CAPECITABINA ACCORD - 150 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Capecitabina accord 150
D.3.2	Product code	[-]
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.3.9.2	Current sponsor code	-
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	3000
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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.2.1.1.1	Trade name	CAPECITABINA ACCORD - 500 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 120 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Capecitabina Accord 500
D.3.2	Product code	[-]
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.3.9.2	Current sponsor code	-
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	3000
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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

advanced pancreatic cancer

tumore del pancreas avanzato

E.1.1.1

Medical condition in easily understood language

advanced pancreatic cancer

tumore del pancreas avanzato

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	10033599
E.1.2	Term	Pancreatic adenocarcinoma metastatic
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

Progression rate after 3 months of treatment
Safety (NCICTC version 4.0)

Tasso di progressione dopo 3 mesi di trattamento
Sicurezza (versione NCICTC 4.0)

E.2.2

Secondary objectives of the trial

Response rate (RECIST version 1.1), PFS and median OS; assessment of reversion from epithelial to mesenchymal cells

Tasso di risposta (RR) (versione RECIST 1.1), PFS e OS mediana; valutazione della reversione da cellule epiteliali a mesenchimali

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

age =18 and < 75 years
Histologically/cytologically confirmed advanced, unresectable pancreatic cancer
Patients Resistant/refractory to a first line chemotherapy including nab-paclitaxel/gemcitabine
Willing and able to comply with all aspects of the protocol
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 at study entry
Life expectancy of at least 3 months

Età compresa tra i 18 e i 75 anni;
Carcinoma pancreatico avanzato non resecabile
confermato istologicamente/citologicamente
Pazienti che hanno fallito una chemioterapia di prima linea con nab-paclitaxel/gemcitabina Performance Status (ECOG) 0-1
Aspettativa di vita di almeno 3 mesi

E.4

Principal exclusion criteria

Previous chemotherapy with capecitabine or 5fluorouracil within 6 months of study entry
Evidence of clinically symptomatic CNS metastases
Patients with only non measurable disease according to RECIST 1.1 criteria
Treatment with chemotherapy or any anti-cancer drug within 3 weeks of the study entry

Chemioterapia precedente con capecitabina o 5
fluorouracil entro 6 mesi dall'entrata in studio
Presenza di metastasi clinicamente sintomatiche del CNS
Pazienti con solo malattia non misurabile secondo i criteri RECIST 1.1
Trattamento con la chemioterapia o qualsiasi farmaco anticancro entro 3 settimane dalla data di arruolamento

E.5 End points

E.5.1

Primary end point(s)

The primary objectives of this trial is to assess the safety and anti-tumor activity of eribulin in
combination with capecitabine, as measured by the rate of progression after three months of treatment
based on local investigator’s assessment according to RECIST v1.1

L'end point primario è il tasso di progressione a 3 mesi e la sicurezza della
combinazione tra eribulina e capecitabina

E.5.1.1

Timepoint(s) of evaluation of this end point

after three months

dopo 3 mesi

E.5.2

Secondary end point(s)

The secondary efficacy endpoints are: PFS, ORR, OS and the assessment of the potential biological effect of eribulin on the mesenchymal to epithelial cell reversion assessed by plasma exosomes. Response to treatment has to be assessed by using the same techniques performed at baseline. At the end of treatment tumor assessment will be performed every 3 months, during follow up visits until PD, for all patients who goes off study for other reason than PD. After PD, six-month assessment of the patient status (dead or alive; with or without recurrence or second primary tumor) is required.

Gli endpoint secondari di efficacia sono: PFS, ORR, OS e la valutazione del potenziale effetto biologico di eribulina sulla reversione mesenchimale a quella epiteliale valutata dagli esosomi plasmatici. La risposta al trattamento deve essere valutata utilizzando le stesse tecniche eseguite al basale. Alla fine del trattamento la valutazione del tumore verr¿ eseguita ogni 3 mesi, durante le visite di follow up fino al PD sia per tutti i pazienti che vanno fuori studio per altre ragioni rispetto al PD. Dopo PD, ¿ necessaria una valutazione semestrale dello stato del paziente (vivo o morto, con o senza recidiva o secondo tumore primario).

E.5.2.1

Timepoint(s) of evaluation of this end point

every 3 months during treatment until disease progression
every 6 months after progression of the disease

ogni 3 mesi durante il trattamento fino a progressione della malattia
ogni 6 mesi dopo progressione della malattia

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

Yes

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)

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

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

Yes

E.8.1.7.1

Other trial design description

singolo braccio

arm single

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

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.8.4.1

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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 chemotherapy treatment of the last patient being treated

ultimo trattamento chemioterapico dell'ultimo paziente in trattamento

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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 best available therapy

la miglior terapia disponibile

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

2018-01-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-12-12

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2018-11-21

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