Clinical Trials Register

Summary
EudraCT Number:	2012-002793-30
Sponsor's Protocol Code Number:	CLISO2
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-03-18
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

2012-002793-30

A.3

Full title of the trial

PHASE II RANDOMIZED STUDY FOR THE PREVENTION OF CUTANEOUS RASH INDUCED BY ERLOTINIB

STUDIO RANDOMIZZATO DI FASE II SULLA PREVENZIONE DEL RASH CUTANEO INDOTTO DA ERLOTINIB

A.3.1

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

PREVENTION STUDY ON SKIN RASH CAUSED BY ERLOTINIB DRUG

STUDIO SULLA PREVENZIONE D’IRRITAZIONI ALLA PELLE DOVUTI AL FARMACO ERLOTINIB

A.3.2

Name or abbreviated title of the trial where available

CLISO 2

A.4.1

Sponsor's protocol code number

CLISO2

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	A.O. SAN GERARDO
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	ROCHE SPA
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	REGIONE LOMBARDIA
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	A.O. SAN GERARDO
B.5.2	Functional name of contact point	Medical Oncology –Trial Office
B.5.3	Address:
B.5.3.1	Street Address	VIA PERGOLESI, 33
B.5.3.2	Town/ city	MONZA
B.5.3.3	Post code	20900
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390392333203
B.5.5	Fax number	00390392332284
B.5.6	E-mail	ricercaindipendente.monza@gmail.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	Yes
D.2.1.1.1	Trade name	Dalacin C
D.2.1.1.2	Name of the Marketing Authorisation holder	PHARMACIA & UPJOHN S.p.A
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.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	ISORIAC 20 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	PIERRE FABRE ITALIA S.p.A.
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.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	TARCEVA
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE
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.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

metastatic inoperable tumour for NSCLC

tumore metastatico in operabile del polmone non a piccole cellule

E.1.1.1

Medical condition in easily understood language

metastatic inoperable tumour for NSCLC

tumore metastatico in operabile del polmone non a piccole cellule

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	15.1
E.1.2	Level	PT
E.1.2	Classification code	10059515
E.1.2	Term	Non-small cell lung cancer metastatic
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

To evaluate whether or not the prescription of the experimental treatment changes the incidence of the cutaneous rash in the first 30 days of treatment with erlotinib

Valutare se la somministrazione del trattamento sperimentale cambia l’incidenza del rash cutaneo nei primi 30 giorni di trattamento con erlotinib.

E.2.2

Secondary objectives of the trial

To evaluate any collateral effects of the preventive treatment. To evidence the curative effectiveness of the experimental treatment in both groups of patients after the onset of rash. To evaluate erlotinib’s activity in the two arms of treatment.

Valutare gli effetti collaterali del trattamento preventivo. Valutare l’efficacia curativa del trattamento sperimentale in entrambi i gruppi di pazienti dopo l’insorgenza di rash. Valutare l’attività di erlotinib nei due bracci di trattamento.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Biological Sub-study of phase II randomized study for the prevention of cutaneous rash induced by erlotinib. Vers. 2 2012-09-03 The objective is to test the chemotaxis in the etiopathogenesis of the correlated rash due to erlotinib and its possible inhibition.

Sottostudio biologico: STUDIO RANDOMIZZATO DI FASE II SULLA PREVENZIONE DEL RASH CUTANEO INDOTTO DA ERLOTINIB Vers. 2 03/09/2012 Obiettivi: Testare il ruolo della chemiotassi nell’eziopatogenesi del rash correlato all’impiego di erlotinib, e l’eventuale inibizione di quest’ ultima.

E.3

Principal inclusion criteria

non small cell lung cancer histological diagnosis;
age > 18 years;
PS 0-2;
Measurable or evaluable illness;
Average marrow reserve;
Adequate liver and renal functionality;
more than one previous chemio treatments; previous treatment completed by at least 3 weeks;
life expectancy > 3 months
adequate geographical closeness
written informed consent;
negative pregnancy test
radiant treatment allowed for palliative intent only if the bone marrow field is radiated < 30% and with complete recovery from any possible collateral effects.

diagnosi cito-istologica di carcinoma polmonare non a piccole cellule;
età > 18 anni;
PS 0-2;
malattia misurabile o valutabile;
riserva midollare nella norma;
adeguata funzionalità epatica e renale;
numero di linee chemioterapiche precedenti superiori a 1; precedente trattamento concluso da almeno 3 settimane;
aspettativa di vita superiore ai 3 mesi;
adeguata accessibilità geografica;
consenso informato scritto;
test di gravidanza negativo;
ammesso trattamento radiante a finalità palliativa purché con campo midollare

E.4

Principal exclusion criteria

symptomatic cerebral secondaries not controlled by an adequate steroid and/or antiepileptic therapy ;
concomitant curative lung radiation therapy
serious concomitant illnesses not compliant to the treatment plan
enrolled in other studies

secondarismi cerebrali sintomatici non controllati da adeguata terapia steroidea e/o antiepilettica;
radioterapia curativa polmonare concomitante;
gravi malattie concomitanti incompatibili con il piano di trattamento;
arruolamento concomitante ad altri studi.

E.5 End points

E.5.1

Primary end point(s)

Possible cutaneous rash onset of grade > 2 in the first 30 days of treatment

Probabilità di insorgenza di rash cutaneo di grado > 2 nei primi 30 giorni di trattamento.

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days

30 giorni

E.5.2

Secondary end point(s)

Evaluation of the plasmatic ranges for triglycerides, cholesterol and liver tests
Calculation of the percentage of solved cutaneous rash (from grade > 2 to grade < 1). Evaluate the objective response of the treatment with erlotinib.

Valutazione dei valori plasmatici di trigliceridi, colesterolo e test epatici.
Calcolo della percentuale di rash cutanei risolti (da grado > 2 a grado < 1).
Valutare la risposta obiettiva al trattamento con erlotinib.

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months

6 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Quality of life

Qualità della vita

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

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

nessun trattamento

no treatment

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

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

LVLS

ultima visita dell'ultimo soggetto

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

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.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)

Doctors will follow the current international guidelines for the best possible treatment to use after a therapy based on Erlotinib.

I medici seguiranno le attuali linee guida internazionali previste per il trattamento della patologia dopo la terapia con Erlotinib.

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

2013-05-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-24

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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