Clinical Trials Register

Summary
EudraCT Number:	2019-001925-28
Sponsor's Protocol Code Number:	FGCL-3019-087
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-01-22
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

2019-001925-28

A.3

Full title of the trial

A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in
combination with Gemcitabine Plus Nab-paclitaxel as Neoadjuvant
Treatment in Patients with Locally Advanced, Unresectable Pancreatic
Cancer

Studio di fase 3, randomizzato, in doppio cieco di pamrevlumab o placebo in combinazione con gemcitabina più nab-paclitaxel come trattamento neoadiuvante in pazienti con carcinoma pancreatico localmente avanzato non resecabile

A.3.1

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

Study of Pamrevlumab or placebo in Combination With Chemotherapy as
Neoadjuvant Treatment in Locally Advanced Pancreatic Cancer

Studio di pamrevlumab o placebo in combinazione con chemioterapia come trattamento neoadiuvante nel carcinoma pancreatico localmente avanzato non resecabile

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

FGCL-3019-087

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03941093

A.5.4

Other Identifiers

Name:

IND number

Number:

011952

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	FIBROGEN
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	FibroGen, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FibroGen, Inc.
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	409 Illinois Street
B.5.3.2	Town/ city	San Francisco, California
B.5.3.3	Post code	94158
B.5.3.4	Country	United States
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	3019-087Study@Fibrogen.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	Pamrevlumab
D.3.2	Product code	[FG-3019]
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	PAMREVLUMAB
D.3.9.1	CAS number	946415-13-0
D.3.9.2	Current sponsor code	FG-3019
D.3.9.3	Other descriptive name	Pamrevlumab
D.3.9.4	EV Substance Code	SUB198085
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	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	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	Yes
D.2.1.1.1	Trade name	Abraxane 5 mg/ml polvere per sospensione per infusione
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe B.V. ( MA n: EU/1/07/428/001)
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	paclitaxel
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Powder and solvent 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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB127678
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	5
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	Ribozar 1g polvere per soluzione per infusione
D.2.1.1.2	Name of the Marketing Authorisation holder	Hikma Farmacêutica (Portugal), S.A. (MA n. :73878.00.00)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	gemcitabina
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Powder 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	GEMCITABINA
D.3.9.1	CAS number	95058-81-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB07892MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
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: 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.2.1.1.1	Trade name	GEMCI-cell® 38 mg/ml Concentrate for Solution for Infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	STADApharm GmbH (MA n. 73750.00.00)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Gemcitabina
D.3.2	Product code	[NA]
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	GEMCITABINA
D.3.9.1	CAS number	95058-81-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB07892MIG
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	38
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: 5
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	Gemcitabine HEXAL® 40 mg / ml concentrato per soluzione per infusionesion
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG (MA n. 80317.00.00)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Gemcitabina
D.3.2	Product code	[NA]
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	GEMCITABINA
D.3.9.1	CAS number	95058-81-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB07892MIG
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	40
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: 6
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	Bendacitabina 40 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Bendalis GmbH (MA n. 71400.00.00)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	gemcitabina
D.3.2	Product code	[NA]
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	GEMCITABINA
D.3.9.1	CAS number	95058-81-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB07892MIG
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	40
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
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

Locally Advanced, Unresectable Pancreatic Cancer

Carcinoma pancreatico localmente avanzato non resecabile

E.1.1.1

Medical condition in easily understood language

Cancer of the pancreas

Tumore del pancreas

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	10033606
E.1.2	Term	Pancreatic cancer non-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 evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab in combination with gemcitabine plus nab-paclitaxel when compared to treatment with gemcitabine plus nab-paclitaxel alone in locally advanced, unresectable pancreatic cancer.

Valutare l'efficacia e la sicurezza del trattamento neoadiuvante con pamrevlumab in combinazione con gemcitabina più nab-paclitaxel rispetto al trattamento con gemcitabina più nab-paclitaxel da solo nel carcinoma pancreatico localmente avanzato non resecabile.

E.2.2

Secondary objectives of the trial

To evaluate the effect of neoadjuvant treatment with pamrevlumab in combination with gemcitabine plus nab-paclitaxel or gemcitabine plus nab-paclitaxel alone on resection rates.

Valutare l'effetto del trattamento neoadiuvante con pamrevlumab in combinazione con gemcitabina più nab-paclitaxel o gemcitabina più nab-paclitaxel da solo sui tassi di resezione.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Understand and sign informed consent; be willing to comply with study procedures, including surgery
2. Age > o =18 years
3. Be a male, or non-pregnant and non-lactating female
4. Negative serum B-hCG pregnancy test at screening for women of childbearing potential
5. Male subjects with partners of childbearing potential and female subjects of childbearing potential are required to use double barrier contraception methods during the conduct of the study and for 3 months after the last dose of study drug
6. Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
7. Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2018 as determined by central imaging
8. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria as determined by central imaging
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
10. Adequate liver function
11. Adequate bone marrow function
12. Adequate renal function
13. Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)

1. Comprendere e firmare il consenso informato; essere disposti a rispettare le procedure dello studio, compreso l’intervento chirurgico
2. Età > o = 18 anni
3. Soggetti di sesso maschile o soggetti di sesso femminile non in stato di gravidanza e allattamento
4. Test di gravidanza sulla beta-gonadotropina corionica umana (B-hCG) risultato negativo allo screening per le donne in età fertile
5. I soggetti di sesso maschile con partner in età fertile e i soggetti di sesso femminile in età fertile sono tenuti a utilizzare metodi contraccettivi a doppia barriera durante la conduzione dello studio e per 3 mesi dopo l’ultima dose del farmaco dello studio
6. Diagnosi comprovata istologicamente di adenocarcinoma duttale pancreatico (PDAC)
7. Carcinoma pancreatico localmente avanzato ritenuto non resecabile in base alle linee guida del National Comprehensive Cancer Network (NCCN)® Versione 2.2018, come determinato mediante diagnostica per immagini centralizzata
8. Malattia misurabile definita secondo i criteri di valutazione della risposta nei tumori solidi RECIST 1.1, come determinata mediante diagnostica per immagini centralizzata
9. Stato di validità dell’Eastern Cooperative Oncology Group (ECOG) di 0 o 1
10. Adeguata funzionalità epatica
11. Adeguata funzionalità del midollo osseo
12. Adeguata funzionalità renale
13. Neuropatia periferica preesistente inferiore a grado 2 (secondo i Criteri comuni di terminologia per gli eventi avversi [CTCAE])

E.4

Principal exclusion criteria

1. Prior chemotherapy or radiation for pancreatic cancer
2. Previous (within the past 3 years) or concurrent malignancy diagnosis except non melanoma skin cancer and in situ carcinomas (excluding in
situ breast cancer)
3. Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted.
4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
5. Any medical or surgical condition that may place the subject at increased risk while on study
6. Any condition potentially decreasing compliance to study procedures
7. Exposure to another investigational drug within 28 days of first dosing visit, or 5 half lives of the investigational drug (whichever is longer)
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infections, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
9. Documented history of drug or alcohol abuse within 6 months of signing informed consent
10. Any medical condition that, in the opinion of the investigator, may pose a safety risk to a subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation

1. Precedente chemioterapia o radioterapia per carcinoma pancreatico
2. Precedente (entro gli ultimi 3 anni) o concomitante diagnosi di tumore maligno, ad eccezione di tumore cutaneo non-melanoma e carcinomi in situ (escluso carcinoma mammario in situ)
3. Intervento di chirurgia maggiore nelle 4 settimane precedenti la firma del modulo di consenso informato. Gli stent biliari sono consentiti.
4. Anamnesi di allergia o ipersensibilità ad anticorpi monoclonali umani, umanizzati o chimerici
5. Qualsiasi condizione medica o chirurgica che potrebbero esporre il soggetto a un maggior rischio durante la partecipazione allo studio
6. Qualsiasi condizione potenzialmente in grado di ridurre la conformità alle procedure dello studio
7. Esposizione a un altro farmaco sperimentale entro 28 giorni dalla prima visita di dosaggio o entro 5 emivite del farmaco sperimentale (a seconda di quale periodo sia più lungo)
8. Malattia intercorrente non controllata, comprese, ma non limitate a, infezioni sistemiche in corso o attive, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, aritmia cardiaca clinicamente significativa o malattia psichiatrica/situazioni sociali che limiterebbero la conformità ai
requisiti dello studio
9. Anamnesi documentata di abuso di farmaci o alcol entro i 6 mesi precedenti la firma del consenso informato
10. Qualsiasi condizione medica che, a giudizio dello sperimentatore, potrebbe costituire un rischio per la sicurezza di un soggetto in questa sperimentazione, potrebbe confondere la valutazione della sicurezza e dell’efficacia, o che potrebbe interferire con la partecipazione allo studio

E.5 End points

E.5.1

Primary end point(s)

Overall survival (OS)

sopravvivenza complessiva (OS)

E.5.1.1

Timepoint(s) of evaluation of this end point

Time from randomization to death due to any cause

tempo dalla randomizzazione al decesso per qualsiasi causa

E.5.2

Secondary end point(s)

Progression-free survival (PFS), defined as the time from randomization until objective tumor progression or death (whichever occurs first)
Change in Patient Reported Outcomes (PROs) as measured by:
- Mean change from baseline during the treatment period in physical function by EORTC-QLQ-C30
- Mean change from baseline during the treatment period in abdominal pain by NCI-PRO-CTCAE
- Mean change from baseline during the treatment period in fatigue by NCI-PRO-CTCAE

-Sopravvivenza libera da progressione (PFS), definita come il tempo dalla randomizzazione fino alla progressione tumorale obiettiva o al decesso (a seconda di quale evento si verifichi prima)
Variazione negli esiti riferiti dal paziente (PRO) misurata mediante:
- Variazione media rispetto al basale durante il periodo di trattamento nella funzionalità fisica mediante EORTC-QLQ-C30
- Variazione media rispetto al basale durante il periodo di trattamento nel dolore addominale mediante NCI-PRO-CTCAE
- Variazione media rispetto al basale durante il periodo di trattamento nell’affaticamento mediante NCI-PRO-CTCAE

E.5.2.1

Timepoint(s) of evaluation of this end point

Time-to-event endpoints will be analyzed using the same methods used in the analysis of OS. For dichotomous secondary endpoints, CMH test
controlling for stratification factors will be used to compare the treatment groups. For continuous endpoints, analysis of covariance with
the baseline value as the covariate will be used. All analyses will be adjusted for the randomization stratification factors.

Gli endpoint relativi al tempo all’evento saranno analizzati utilizzando gli stessi metodi utilizzati nell’analisi della sopravvivenza complessiva (OS). Per gli endpoint secondari dicotomici, verrà usato il test di Cochran-Mantel-Haenszel (CMH), eseguendo un controllo dei fattori di stratificazione, per confrontare i gruppi di trattamento. Per gli endpoint continui, verrà usata l’analisi della covarianza con il valore basale come covariata. Tutte le analisi saranno corrette per i fattori di stratificazione della randomizzazione.

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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

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

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

Information not present in EudraCT

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

Canada

China

Israel

Korea, Republic of

New Zealand

United States

Austria

Belgium

France

Germany

Italy

Netherlands

Spain

United Kingdom

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

LSLV
All subjects will be followed for survival (until death) or until the last subject to complete treatment reaches 18 months post-treatment.

LSLV
tutti i soggetti saranno seguiti per la sopravvivenza (fino al decesso) o fino a quando l'ultimo soggetto che completa il trattamento raggiunge i 18 mesi di post-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:

128

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

128

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

256

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)

Subjects participation will continue in the follow-up period beyond their completion of treatment. All subjects will be followed for progression, any additional anti-cancer therapy received and survival until death or until the last subject completes 18 months follow-up. During this time, there are no restrictions to the adjuvant or second line therapy prescribed by their treating physicians. There are no plans for continuing treatment or care once their participation in the trial has ended.

La partecipazione dei soggetti proseguirà nel periodo di follow-up oltre il completamento del trattamento. Tutti i soggetti saranno seguiti per progressione, qualsiasi ulteriore terapia antitumorale ricevuta e sopravvivenza fino al decesso o fino a quando l’ultimo soggetto avrà completato i 18 mesi di follow-up.
Durante questo periodo, non vi sono limitazioni per la terapia adiuvante o la terapia di seconda linea prescritta dai propri medici curanti...
vedere inglese

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

2020-03-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-22

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

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