Clinical Trials Register

Summary
EudraCT Number:	2018-001600-12
Sponsor's Protocol Code Number:	20177097
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:	2021-05-20
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

2018-001600-12

A.3

Full title of the trial

Phase II randomized study evaluating the efficacy of panitumumab (VEctibix) and Trifluridine-Tipiracil (LOnsurf) in pretreated RAS wild type metastatic colorectal cancer patients: the VELO trial

Studio randomizzato di fase II che valuta l’efficacia del Panitumumab (VEctibix) in combinazione con Trifluridina-Tipiracile (LOnsurf) in pazienti pre-trattati affetti da tumore del colon-retto metastatico RAS wild type: studio VELO

A.3.1

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

Phase II study of Panitunumab plus Cetuximab in pretreated in patients with metastatic colorectal cancer

Studio di fase II con Panitunumab più Cetuximab in pazienti con cancro del colon retto metastatico

A.3.2

Name or abbreviated title of the trial where available

VELO

A.4.1

Sponsor's protocol code number

20177097

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	Dipartimento di Medicina di Precisione - Università degli studi della Campania "L. Vanvitelli"
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	Amgen
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	Dipartimento di Medicina di Precisione - Università degli Studi della Campania "Luigi Vanvitelli"
B.5.2	Functional name of contact point	UOC Oncoematologia
B.5.3	Address:
B.5.3.1	Street Address	via pansini n.5
B.5.3.2	Town/ city	Napoli
B.5.3.3	Post code	80131
B.5.3.4	Country	Italy
B.5.4	Telephone number	0815666688
B.5.5	Fax number	0815666688
B.5.6	E-mail	daniela.renato.trials@outlook.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	VECTIBIX - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO 1 FLACONCINO (VETRO) 20 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN EUROPE B.V.
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	VECTIBIX
D.3.2	Product code	[VECTIBIX]
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	PANITUMUMAB
D.3.9.1	CAS number	339177-26-3
D.3.9.2	Current sponsor code	VECTIBIX
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	20
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	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	LONSURF - 15 MG/6,14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER AL/AL - 20 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	LES LABORATOIRES SERVIER
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	LONSURF
D.3.2	Product code	[LONSURF]
D.3.4	Pharmaceutical form	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	trifluridina/tipiracil
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	70
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

mCRC

Tumore del colon-retto metastatico

E.1.1.1

Medical condition in easily understood language

Colorectal cancer

Tumore del colon-retto

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	HLGT
E.1.2	Classification code	10017991
E.1.2	Term	Gastrointestinal neoplasms malignant and unspecified
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assess the efficacy of panitumumab in combination with Trifluridine- Tipiracile vs standard third line therapy (Trifluridine-Tipiracile) as measured by PFS

Valutare l'efficacia in termini di PFS della combinazione di Panitumumab più Trifluridina-Tipiracile verso Trifluridine-Tipiracile

E.2.2

Secondary objectives of the trial

Compare the activity of panitumumab in combination with Trifluridine-Tipiracile vs standard third line therapy (Trifluridine-Tipiracile) as measured by ORR
Compare the efficacy of panitumumab in combination with Trifluridine-Tipiracile vs standard third line therapy (Trifluridine-Tipiracile) as measured by OS
Asses the safety and tolerability of panitumumab in combination with Trifluridine-Tipiracile vs standard third line therapy (Trifluridine-Tipiracile)

Valutare l'attività in termini di ORR della combinazione di Panitumumab più Trifluridina-Tipiracile verso Trifluridine-Tipiracile
Valutare l'efficacia in termini di OS della combinazione di Panitumumab più Trifluridina-Tipiracile verso Trifluridine-Tipiracile
Valutare la siurezza e tollerabilità della combinazione di Panitumumab più Trifluridina-Tipiracile verso Trifluridine-Tipiracile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Histologically proven diagnosis of colorectal adenocarcinoma
• Diagnosis of metastatic disease
• RAS (NRAS and KRAS exon 2,3 and 4) wild-type in tissue at initial
diagnosis
• Efficacy of a first line therapy containing an anti-EGFR agent
(panitumumab or cetuximab) with a major response achieved (complete
or partial response)
• A second line therapy
• More than 4 months from last dose of anti-EGFR agent administered
in first line treatment before randomization.
• ECOG Performance Status 0-1

Diagnosi istologici confermata di adenocarcinoma del colon-retto
Diagnosi di malattia metastatica
Diagnosi di adenocarcinoma all RAS wild type
Risposta maggiore raggiunta (risposta parziale o completa) con una terapia di I linea contenente anti EGFR
Seconda linea di terapia praticata
Intervallo maggiore di 4 mesi dall'ultima somministrazione di anti-EGFR prima della randomizzazione
PS secondo ECOG 0-1

E.4

Principal exclusion criteria

• Any contraindication to use Trifluridine - Tipiracile or Panitumumab
• Active uncontrolled infections
• Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
• Pregnancy
• Breastfeeding
• Interstitial lung disease or pulmonary fibrosis
• Grade III or IV heart failure (NYHA classification)

Qualsiasi controindicazione all'uso di Trifluridine - Tipiracile o Panitumumab
Infezioni attive non controllate
Anamnesi patologica remota di pregressa neoplasia maligna eccetto per carcinoma squamoso cellulare o basalioma della cute (trattati) o carcinoma in situ della cervice
Gravidanza
Allattamento
Malattia polmonare interstiziale o fibrosi polmonare
Scompenso cardiaco di grado III o IV

E.5 End points

E.5.1

Primary end point(s)

PFS: defined as the time from randomization to the earliest documented disease progression or death due to any cause

PFS: definito come il tempo dalla randomizzazione alla prima progressione della malattia documentata o morte dovuta a qualsiasi causa

E.5.1.1

Timepoint(s) of evaluation of this end point

All subjects will be followed until death and data on subsequent treatment will be collected. Follow-up information on tumor status and vital status will be updated every 3 months until death

Tutti i soggetti saranno seguiti fino alla morte e saranno raccolti i dati sui trattamenti successivi. Le informazioni sullo stato del tumore e sulle condizioni cliniche verranno aggiornate ogni 3 mesi fino al decesso

E.5.2

Secondary end point(s)

• ORR: per the Response Evaluation Criteria in Solid Tumors (RECIST),
version 1.1 (v1.1), defined as the number of patients achieving an
overall best response of complete or partial response divided by the total
number of patients
• OS: defined as the time from randomization to death due to any cause
of panitumumab in combination with Trifluridine-Tipiracile vs
Trifluridine-Tipiracile
• Safety analysis: defined as the evaluation of incidence and severity of
Adverse Events (AEs)

ORR: secondo i Response Evaluation Criteria in Solid Tumors (RECIST), versione 1.1 (v1.1), è definita come il numero di pazienti che ottengono
una risposta completa o parziale divisa per il numero totale di pazienti
OS: definito come il tempo dalla randomizzazione alla morte per qualsiasi causa
Analisi di sicurezza: definita come la valutazione dell'incidenza e della
gravità degli eventi avversi (AE)

E.5.2.1

Timepoint(s) of evaluation of this end point

All subjects will be followed until death and data on subsequent treatment will be collected. Follow-up information on tumor status and vital status will be updated every 3 months until death

Tutti i soggetti saranno seguiti fino alla morte e saranno raccolti i dati sui trattamenti successivi. Le informazioni sullo stato del tumore e sulle
condizioni cliniche verranno aggiornate ogni 3 mesi fino al decesso

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

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 Whole trial may be discontinued prematurely in the event of any of
the following:
New information leading to unfavorable risk-benefit judgment of the
trial drug
Unfavorable safety findings
Sponsor's decision that continuation of the trial is unjustifiable for
medical or ethical reasons
Poor enrollment of subjects

L'intero trial può essere prematuramete discontinuato se: si rendono disponibili nuovi dati su un rapporto rischio/beneficio non favorevole per il trattamento
altre informazioni di sicurezza non favorevoli
decisione dello Sponsor basata su motivi clinici/etici
scarso arruolamento

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

112

F.4.2

For a multinational trial

F.4.2.1

In the EEA

112

F.4.2.2

In the whole clinical trial

112

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)

All subjects will be followed until death and data on subsequent treatment will be collected. Follow-up information on tumor status and vital status will be updated every 3 months until death

Tutti i soggetti saranno seguiti fino alla morte e saranno raccolti i dati sui trattamenti successivi. Le informazioni sullo stato del tumore e sulle
condizioni cliniche verranno aggiornate ogni 3 mesi fino al decesso

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

2019-05-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-04-12

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

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