Clinical Trials Register

Summary
EudraCT Number:	2017-004675-31
Sponsor's Protocol Code Number:	AMCmedonc17-010
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:	2021-06-04
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

2017-004675-31

A.3

Full title of the trial

A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy

Uno studio randomizzato di Fase II sul trattamento di seconda linea con irinotecan liposomiale e S1 rispetto a irinotecan liposomiale e 5-fluorouracile in pazienti con carcinoma pancreatico metastatico che non hanno ottenuto risultati con la chemioterapia di prima linea a base di gemcitabina

A.3.1

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

Phase II study of treatment with liposomal and S1 irinotecan versus liposomal and 5-fluorouracil irinotecan in patients with metastatic pancreatic cancer who did not achieve results with gemcitabine first-line chemotherapy

Studio di fase II sul trattamento con irinotecan liposomiale e S1 rispetto a irinotecan liposomiale e 5-fluorouracile in pazienti con carcinoma del pancreas metastatico che non hanno ottenuto risultati con la chemioterapia di prima linea a base di gemcitabina

A.3.2

Name or abbreviated title of the trial where available

NAPAN study

NAPAN Study

A.4.1

Sponsor's protocol code number

AMCmedonc17-010

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	ACADEMIC MEDICAL CENTRE AMSTERDAM
B.1.3.4	Country	Netherlands
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	University of Amsterdam
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Academic Medical Center
B.5.2	Functional name of contact point	Eva van Daalen
B.5.3	Address:
B.5.3.1	Street Address	Meibergdreef 9
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1105 AZ
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31205668229
B.5.5	Fax number	+31205668229
B.5.6	E-mail	trialmedonc@amc.nl

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	Onivyde Pegilato Liposomiale
D.2.1.1.2	Name of the Marketing Authorisation holder	Les laboratoires Servier
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	Onivyde Liposomiale Pegilato
D.3.2	Product code	[EMA/515476/2016]
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	irinotecan anhydrous free base
D.3.9.1	CAS number	97682-44-5
D.3.9.2	Current sponsor code	Onivyde Liposomiale Pegilato
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	60
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	Teysuno
D.2.1.1.2	Name of the Marketing Authorisation holder	Nordic Group BV
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Teysuno, S-1
D.3.2	Product code	[EMA/20503/2012]
D.3.4	Pharmaceutical form	Gastro-resistant capsule, hard
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.3.8	INN - Proposed INN	tegafur, gimeracil e oteracil
D.3.9.1	CAS number	150863-82-4
D.3.9.2	Current sponsor code	S-1
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	30
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	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.2.1.1.1	Trade name	Sodio Levofolinato medac 50 mg/ml soluzione iniettabile o per infusione
D.2.1.1.2	Name of the Marketing Authorisation holder	MEDAC
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	Sodio levofolinato
D.3.2	Product code	[V03 AF 10]
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	acido folinico
D.3.9.1	CAS number	58-05-9
D.3.9.2	Current sponsor code	Sodio levofolinato
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	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	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.2.1.1.1	Trade name	FLUOROURACILE TEVA - 5 G/100 ML SOLUZIONE PER INFUSIONE 1 FLACONCINO DA 100 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA ITALIA S.R.L.
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	5-FLUOROURACILE
D.3.2	Product code	[15859]
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	5-FLUOROURACILE
D.3.9.1	CAS number	51-21-8
D.3.9.2	Current sponsor code	5-FLUOROURACILE
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	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

pancreatic cancer

carcinoma pancreatico metastatico

E.1.1.1

Medical condition in easily understood language

advanced pancreatic cancer

tumore al pancreas in stadio 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

Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose
(MTD) of nal-IRI when co-administered with fixed dose S1 in patients
with metastatic pancreatic cancer.
Phase II part: Efficacy between the treatment arms in terms of
progression free survival.

Fase di Run-in: Dose limite di tossicità (DLT) e dose massima tollerata (MTD) di nal-IRI in caso di co-somministrazione con dose fissa S1 in pazienti con carcinoma pancreatico metastatico.
Parte II: efficacia tra i bracci di trattamento in termini di sopravvivenza libera da progressione.

E.2.2

Secondary objectives of the trial

Overall survival
Response rate according to RECIST 1.1
Adverse events according to NCI CTC version 4.0
Quality of life

Sopravvivenza globale
Tasso di risposta secondo RECIST 1.1
Eventi avversi secondo NCI CTC versione 4.0
Qualità della vita

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

= 18 years of age
Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
Documented metastatic disease
Previously treated with gemcitabine or gemcitabine containing therapy,
or progression within 6 months of adjuvant gemcitabine treatment
Adequate hepatic, renal and hematological function
Caucasian

Età = 18 anni
Adenocarcinoma istologicamente o citologicamente confermato del pancreas esocrino
Malattia metastatica documentata
Precedentemente trattati con gemcitabina o gemcitabina contenente terapia,
o progressione entro 6 mesi dal trattamento adiuvante con gemcitabina
Funzione epatica, renale ed ematologica adeguata
caucasico

E.4

Principal exclusion criteria

KPS < 70
Any clinically significant gastrointestinal disorder, including hepaticdisorders, bleeding, inflammation, occlusion, or diarrhea > grade 2
Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically
significant abnormal findings
Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's
health
Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
Known hypersensitivity to any of the components of liposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
History of severe and unexpected reactions to fluoropyrimidine therapy
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of liposomal irinotecan (nal-IRI).
Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine

KPS <70
Qualsiasi disturbo gastrointestinale clinicamente significativo, inclusi disturbi epatici, sanguinamento, infiammazione, occlusione o diarrea> grado 2
Gravi eventi tromboembolici arteriosi (infarto del miocardio, angina pectoris instabile, ictus) negli ultimi 6 mesi
Insufficienza cardiaca congestizia di classe III o IV NYHA, aritmie ventricolari o pressione sanguigna incontrollata. O noto ECG anormale con risultati anormali clinicamente significativi
Infezione attiva o febbre inspiegabile> 38,5 ° C (esclusa la febbre del tumore), che secondo il medico potrebbe compromettere la salute del paziente
Uso corrente o qualsiasi uso nelle ultime due settimane di forti induttori / inibitori dell'enzima CYP3A e / o potenti inibitori dell'UGT1A
Ipersensibilità nota a uno qualsiasi dei componenti dell'irinotecan liposomiale (nal-IRI) altre formulazioni liposomiali di irinotecan, irinotecan, fluoropirimidine o leucovorin.
Ipersensibilità a uno qualsiasi dei principi attivi (tegafur, gimeracil e oteracil)
Storia di reazioni gravi e inattese alla terapia con fluoropirimidina
Deficit nota di diidropirimidina deidrogenasi (DPD)
Allattamento al seno, gravidanza nota, test di gravidanza sierico positivo o riluttanza a utilizzare un metodo affidabile di controllo delle nascite, durante la terapia e per 3 mesi dopo l'ultima dose di irinotecan liposomiale (nal-IRI).
Trattamento entro 4 settimane con inibitori della DPD, inclusa la sorivudina o i suoi analoghi chimicamente correlati come la brivudina

E.5 End points

E.5.1

Primary end point(s)

Run in phase: Dose limiting toxicity (DLT) and Maximal tolerated dose (MTD) of nal-IRI when co-administered with fixed dose S1 in patients with metastatic pancreatic cancer.
Phase II part: Efficacy between the treatment arms in terms of progression free survival.

Fase di run-in: dose limite di tossicità (DLT) e dose massima tollerata (MTD) di nal-IRI in caso di co-somministrazione con dose fissa S1 in pazienti con carcinoma pancreatico metastatico.
Parte II: efficacia tra i bracci di trattamento in termini di sopravvivenza libera da progressione.

E.5.1.1

Timepoint(s) of evaluation of this end point

Evaluation with CTscan/ MRI will take place every 2 months

Valutazione con CTscan / MRI che avrà luogo ogni 2 mesi

E.5.2

Secondary end point(s)

Quality of life; Response rate according to RECIST 1.1; Adverse events according to NCI CTC version 4.0; Overall survival

Qualità della vita; Tasso di risposta secondo RECIST 1.1; Eventi avversi secondo NCI CTC versione 4.0; Sopravvivenza globale

E.5.2.1

Timepoint(s) of evaluation of this end point

Quality of life will be evaluated every 2 months; Evaluation with CTscan/ MRI will take place every 2 months; Adverse events will be evaluated every 2 weeks; Evaluation with CTscan/ MRI will take place every 2 months

La qualità della vita sarà valutata ogni 2 mesi; La valutazione con CTscan / MRI avrà luogo ogni 2 mesi; Gli eventi avversi saranno valutati ogni 2 settimane; La valutazione con CTscan / MRI avrà luogo ogni 2 mesi

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

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)

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

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

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

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

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

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

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)

Follow up for late toxicity every 8 weeks and report date of death

Monitorare la tossicità tardiva ogni 8 settimane e riportare la data di morte

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

2021-05-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-23

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

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Clinical trials