Clinical Trials Register

Summary
EudraCT Number:	2017-002219-33
Sponsor's Protocol Code Number:	DISTINCTIVE
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:	2021-09-10
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-002219-33

A.3

Full title of the trial

seconD-line folfiri/aflIbercept in proSpecTIvely stratified, anti-EGFR resistaNt, metastatic coloreCTal cancer patIents with RAS Validated wild typE status

A.3.1

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

seconD-line folfiri/aflIbercept in metastatic coloreCTal cancer patIents

Pazienti portatori di tumore del colon retto metastatico K-RAS WT resistenti al trattamento di prima linea con terapia contenente antiEGFR, trattati con FOLFIRI e Aflibercept e stratificati secondo il livello di VEGFR2

A.3.2

Name or abbreviated title of the trial where available

seconD-line folfiri/aflIbercept in proSpecTIvely stratified metastatic coloreCTal cancer patIents

Trattamento di seconda linea con folfiri aflibercept in pazienti affetti da carcinoma del colon rett

A.4.1

Sponsor's protocol code number

DISTINCTIVE

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	FONDAZIONE GISCAD (GRUPPO ITALIANO PER LO STUDIO DEI CARCINOMI DELL'APPARATO DIGERENTE)
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	Sanofi
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	Fondazione GISCAD
B.5.2	Functional name of contact point	Ufficio Operativo
B.5.3	Address:
B.5.3.1	Street Address	Via Gattinoni, 4
B.5.3.2	Town/ city	Vanzago
B.5.3.3	Post code	20010
B.5.3.4	Country	Italy
B.5.4	Telephone number	0284968409
B.5.5	Fax number	0284968441
B.5.6	E-mail	centrotrialgiscad@yahoo.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	ZALTRAP - 25 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONE (VETRO) - 100 MG/4 ML - 3 FLACONI
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS GROUPE
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	zaltrap
D.3.2	Product code	[42689024]
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	AFLIBERCEPT
D.3.9.1	CAS number	862111-32-8
D.3.9.2	Current sponsor code	ZALTRAP
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
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)	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	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	Yes
D.3.11.13.1	Other medicinal product type	prodotto mediante tecnologia del DNA
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	IRINOTECAN HOSPIRA - 20MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 100MG/5ML
D.2.1.1.2	Name of the Marketing Authorisation holder	HOSPIRA 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	IRINOTECAN
D.3.2	Product code	[37037025]
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 CLORIDRATO TRIIDRATO
D.3.9.1	CAS number	100286-90-6
D.3.9.2	Current sponsor code	CAMPTO
D.3.9.3	Other descriptive name	CAMPTO 20 mg / ml, concentrate for solution for infusion
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	FLUOROURACILE TEVA - 500 MG/10 ML SOLUZIONE PER INFUSIONE ENDOVENOSA 5 FLACONI DA 500 MG
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	Fluorouracile teva
D.3.2	Product code	[26542035]
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 Intravenous bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FLUOROURACILE
D.3.9.1	CAS number	51-21-8
D.3.9.2	Current sponsor code	Fluorouracile Teva
D.3.10	Strength
D.3.10.1	Concentration unit	g/ml gram(s)/millilitre
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.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

The study will a be a biologically enriched, prospectively stratified phase II trial in RAS wild type metastatic colorectal cancer patients progressing after first-line treatment with oxaliplatin, fluoropyrimidines and an anti-EGFR monoclonal antibody

Studio di fase II, biologicamente arricchito, stratificato e prospettico in pazienti affetti da tumore colo-rettale metastatico, RAS WT, in progressione dopo un trattamento di prima linea con oxaliplatino, fluoropirimidine e un anticorpo monoclonale anti-EGFR

E.1.1.1

Medical condition in easily understood language

advanced colorectal cancer patients

pazienti affetti da tumore colo-rettale metastatico

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10017947
E.1.2	Term	Gastrointestinal disorders
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Overall Survival (OS) according to VEGFR2

Sopravvivenza Globale (OS) in accordo ai valori di VEGFR2

E.2.2

Secondary objectives of the trial

Overall Survival (OS)
Progression Free Survival (PFS)
Response Rate
Toxicity Profile
Angiogenetic factors levels concentration before and during treatment.

Sopravvivenza Globale (OS)
Sopravvivenza Libera da Progressione (PFS)
Tasso di Risposta (RR)
Tossicità
Livello dei fattori angiogenici prima e durante il trattamento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Histological confirmation of colorectal cancer
• Confirmed RAS wild type patient treated with an oxaliplatin-anti EGFR treatment in 1st line
• At least one lesion measurable with CT or MRI scan
• Radiologically documented progression while on or after discontinuation of treatment with FOLFOX in combination with an anti-EGFR monoclonal antibody (either cetuximab or panitumumab)
• Life expectancy ¿ 3 months
• Netrophils count ³ 1.5 x 109/L
• Platelets count ³ 100 x 109/L
• Hemoglobin ³ 9 g/dL
• Creatinine £ 1.5 mg/dL, Proteinuria <2+ (dipstick urinalysis with reactive stripes or Combur test) or =1g/24hour.Bilirubin £ 1.5 x ULN
• AST and ALT £ 2.5 x ULN (< 5 ULN in case of liver metastases)
• Informed written consent
• ECOG Performance Status < 2
• Age ¿18 yrs
• Regular follow-up feasible

• Conferma istologica di tumore colorettale
• Conferma di tumore colorettale metastatico RAS WT in paziente trattato in prima linea con oxaliplatino, fluoropirimidine e un anticorpo monoclonale anti-EGFR.
• Almeno una lesione misurabile con TAC o risonanza magnetica
• Progressione di malattia radiologicamente documentata dopo FOLFOX in combinazione con un anticorpo monoclonale anti-EGFR (sia cetuximab o panitumumab)
• Aspettativa di vita ¿ a 3 mesi
• Conteggio dei Neutrofili ³ 1.5 x 109/L
• Conteggio delle Piastrine ³ 100 x 109/L
• Concentrazione dell’emoglobina ³ 9 g/dL
• Creatinina £ 1.5 mg/dL, Proteinuria <2+ (analisi delle urine con strisce reattive o Combur test) or =1g/nelle 24 ore. Bilirubina £ 1.5 x ULN
• AST and ALT £ 2.5 x ULN (< 5 ULN in caso di metastasi epatiche)
• Consenso informato scritto
• ECOG P.S. < 2
• Età ¿18 yrs
• Fattibilità di regolare follow-up
• Test negativo di gravidanza per le pazienti in età fertile
•dopo la fine del trattamento dello studio

E.4

Principal exclusion criteria

• Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
• Treatment with any other investigational medicinal product within 28 days prior to First Study treatment.
• Other serious and uncontrolled non-malignant disease,
• History or evidence upon physical examination of CNS metastasis unless adequately treated
• Gilbert’s syndrome
• Intolerance to atropine sulfate or loperamide
• Known dihydropyrimidine dehydrogenase deficiency
• Treatment with CYP3A4 inducers unless discontinued > 7 days prior to First Study treatment.
• Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or diverticulitis.
• Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years,
• Major surgery or traumatic injury within the last 28 days or until the surgical wound is fully healed whichever came later
• Negative test for pregnancy on serum in fertile age executed within 1 week (7 days) befere the starting therapy,
• Patients with known allergy to any excipient to study drugs,
• Bowel obstruction.
• Uncontrolled infections
• Known drugs or alcohol abuse
• History of severe cardiovascular disease within 6 months prior to First Study treatment, for example cerebrovascular accidents, myocardial infarction, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication.
Uncontrollable hypertension, when treated with three or more drugs.

• concomitante protocollo che prevede l'utilizzo di una terapia antitumorale (chemioterapia, terapia a target molecolare, immunoterapia)
Trattamento con induttori del CYP3A4, a meno che non siano stati sospesi almeno 7 giorni prima dell'avvio dello studio
. Trattamento con qualsiasi altro medicinale sperimentale nei 28 giorni precedenti.
• Altra grave malattia non tumorale e non controllata
• Metastasi cerebrali, non adeguatamente trattate
• Sindrome di Gilbert
• Intolleranza al solfato di atropina o alla loperamide
• Deficienza della dihydropyrimidina dehydrogenasi
• Trattamento con induttori del CYP3A4
• Presenza di una delle seguenti caratteristiche 3 mesi prima della inclusione nello studio : grado 3-4 di sanguinamento gastrointestinale (a meno che a causa del tumore asportato), ulcera peptica resistente al trattamento, esofagite erosiva o gastrite, malattie intestinali infiammatorie o infettive, o diverticolite.
• Altra neoplasia maligna concomitante o precedente, ad eccezione di: carcinoma della cervice uterina in-situ adeguatamente trattato; carcinoma basale o a cellule squamose della pelle, cancro in altra sede in remissione completa per> 5 anni
• Chirurgia maggiore o lesione traumatica nei 28 giorni precedenti o fino a quando la ferita chirurgica sia completamente guarita
• test negativo di gravidanza su siero per le pazienti in età fertile eseguito entro 1 settimana (7 giorni) prima dell'inizio dello studio
• Pazienti con allergia nota ai farmaci contenuti nel trattamento
• Occlusione intestinale.
• Infezioni incontrollate
• Abuso di alcool o droghe
• Storia di gravi malattie cardiovascolari nei 6 mesi prima del trattamento ad esempio accidenti cerebrovascolari, infarto del miocardio, angina instabile, di grado II o superiore sec. La New York Heart Association (NYHA) insufficienza cardiaca congestizia (CHF), grave aritmia cardiaca in trattamento
• Ipertensione incontrollabile o se trattata con tre o più farmaci.

E.5 End points

E.5.1

Primary end point(s)

Overall Survival (OS)

Sopravvivenza Globale (OS)

E.5.1.1

Timepoint(s) of evaluation of this end point

Overall Survival (OS) will be defined as the interval between the start of Aflibecept-FOLFIRI therapy to death (of any cause) or cut-off date for OS analysis whichever comes first

Overall Survival (OS) è definita come intervallo tra l'inizio del trattamento al decesso

E.5.2

Secondary end point(s)

Progression Free Survival; Response Rate (RR); Toxicities

Sopravvivenza Libera da Progressione ; Response Rate (RR); Tossicità

E.5.2.1

Timepoint(s) of evaluation of this end point

• Progression free survival (PFS) will be defined as the interval between the start of Aflibecept-FOLFIRI therapy to progression or death or cut-off date for OS analysis whichever comes first; • Response Rate (RR) will be evaluated after 8 weeks of treatment and defined according to the Response Evaluation Criteria in Solid Tumours (RECIST), v. 1.1; • Toxicities will be evaluated according to NCI-CTC (National Cancer Institute-Common Toxicity Criteria) 4.03 at every chemotherapy cycle. All the patients receiving at least one cycle will be considered evaluable for toxicity. No evaluations are planned between one cycle and the other

Sopravvivenza Libera da Progressione definita come intervallo tra l'inizio della terapia alla progressione; • Response Rate (RR) valutata dopo 8 settimane di trattamento definita secondo RECIST; Valutata secondo NCI-CTC ad ogni ciclo di terapia

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

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

Yes

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

Fase II biologicamente arricchita

Biologically enriched phase II clinical trial

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

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

The treatment should be continued until disease progression or unacceptable toxicity occurs

Il trattamento verrà somministrato fino a progressione di malattia o tossicità inaccettabile

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:

120

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

151

F.4.2

For a multinational trial

F.4.2.1

In the EEA

151

F.4.2.2

In the whole clinical trial

151

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)

During the follow up
• Evaluation visit
• Physical examination (including evaluation of vital signs and performance status) at least every 12 weeks ¿
• Laboratory tests (hematology, clinical chemistry, CEA) and urinalysis at least every 12 weeks
• Evaluation of CT scan or MRI for tumor assessment every 12 weeks, until disease progression.
• Data about further anti-cancer therapy

Durante il follow-up
Visita, esami ematici e delle urine, esami strumentali almeno ogni 12 settimane

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

2017-12-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-24

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials