Clinical Trials Register

Summary
EudraCT Number:	2010-024067-41
Sponsor's Protocol Code Number:	COLTONE
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-12-12
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

2010-024067-41

A.3

Full title of the trial

Pilot study of sequential adjuvant chemotherapy regimen including non-pegylated Liposomal Doxorubicin (MYOCET) in combination with Cyclophosphamide and Paclitaxel in elderly patients with diagnosis of early breast cancer (COLT-ONE study).

Studio pilota di chemioterapia adiuvante sequenziale con Doxorubicina Liposomiale non pegilata (Myocet) e Paclitaxel nella paziente anziana con diagnosi di carcinoma della mammella

A.3.1

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

Studio pilota di chemioterapia adiuvante sequenziale con Doxorubicina Liposomiale non pegilata (Myocet) e Paclitaxel nella paziente anziana con diagnosi di carcinoma della mammella

A.3.2

Name or abbreviated title of the trial where available

COLTONE

A.4.1

Sponsor's protocol code number

COLTONE

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	F.A.R.O. FONDAZIONE PER LE ATTIVITA' DI RICERCA IN ONCOLOGIA
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	FARO onlus(Fondazione per le attivita' di ricerca in Oncologia)
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	U.O. Oncologia Medica
B.5.2	Functional name of contact point	Ufficio Sperimentazioni Cliniche
B.5.3	Address:
B.5.3.1	Street Address	Via Roma,151
B.5.3.2	Town/ city	Pontedera
B.5.3.3	Post code	56025
B.5.3.4	Country	Italy
B.5.4	Telephone number	0587-098707
B.5.5	Fax number	0587-098709
B.5.6	E-mail	seg.scie-onco@usl5.toscana.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	MYOCET
D.2.1.1.2	Name of the Marketing Authorisation holder	CEPHALON Srl
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	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	Doxorubicin
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
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	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.2.1.2	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	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	Cyclophosphamide
D.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.3	Concentration number	600
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	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.2.1.2	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	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.3.10	Strength
D.3.10.1	Concentration unit	mg/m2 milligram(s)/square meter
D.3.10.3	Concentration number	80
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	Yes
D.3.11.13.1	Other medicinal product type	chemioterapico

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

Elderly patients with diagnosis of early breast Cancer candidate to adjuvant chemotherapy.

Pazienti anziane con diagnosi di carcinoma della mammella in stadio iniziale candidate ad una chemioterapia adiuvante

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	14.0
E.1.2	Level	PT
E.1.2	Classification code	10006187
E.1.2	Term	Breast cancer
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

The primary end point of the study is to evaluate the feasibility of a sequential adjuvant chemotherapy regimen including non-pegylated Liposomal Doxorubicin(Myocet)in combination with Cyclophosphamide and Paclitaxel, in terms of observed cardiovascular events of any grade of NCI scale (National Cancer Institute Common Toxicity Criteria) since two years from beginning of the treatment.

Valutare la fattibilita' di un regime chemioterapico sequenziale con Doxorubicina Liposomiale non pegilata (Myocet) associata a Ciclofosfamide, seguiti da Paclitaxel in termini di comparsa di eventi cardiovascolari entro i due anni dall’ inizio del trattamento di grado uguale o superiore al I della scala NCI

E.2.2

Secondary objectives of the trial

Evaluate quality of life of this elderly population by the use of a validated test (EORTC QLQ-c30).

Valutare l’impatto del trattamento sulla qualita' di vita del paziente anziano attraverso l’uso di un test validato del trattamento chemioterapico(EORTC QLQ-c30). - Valutare la fattibilita' del regime chemioterapico sequenziale con Doxorubicina Liposomiale non pegilata (Myocet) associata a Ciclofosfamide, seguiti da Paclitaxel in termini di tossicita' ematologica e non ematologia. - L’ intervallo libero da ripresa di malattia dell’ intera popolazione in studio

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Histological breast cancer diagnosis with stage I-III; positive axillary lymph-node or negative axillary lymph-nodes but at high risk for at least one of the following features: high nuclear grade, negative hormone receptors, high Ki-67; ECOG 0-1;age ≥ 65 years; adequate Kidney function: creatininemia < 1,3 mg/dl or creatinine's clearance > 65 ml/min;adequate liver function:bilirubin < 1,5 mg/dl,alkaline phosphatase, SGOT, SGPT lower of 2,5 times the normal value;adequate bone marrow function:haemoglobin > 10 mg/dl, neutrophils > 1,8 x 109/L,plates > 100 x 109/L;normal left ventricular ejection fraction(F.E. more than 50%);written informed assent.

•Diagnosi istologica di carcinoma della mammella infiltrante •Linfonodi ascellari positivio linfonodi ascellari negativi ma ad alto rischio di ripresa di malattia con almeno una delle seguenti caratteristiche: G3, RO-, Ki-67 elevato. •Stadio della malattia I-III •ECOG PS 0-1 •eta' ≥ 65 anni •Adeguata funzionalita' renale: creatininemia < 1,3 mg/dl o clearance della creatinina calcolata > 65 ml/min •Adeguata funzionalita' epatica: bilirubinemia < 1,5 mg/dl, fosfatasi alcalina, SGOT, SGPT < 2,5 volte il valore normale •Adeguata funzionalita' midollare: emoglobina > 10 mg/dl, Neutrofili > 1,8 x 109/L, piastrine > 100 x 109/L •Frazione di eiezione ventricolare sinistra normale (F.E. superiore al 50%) •Consenso informato scritto.

E.4

Principal exclusion criteria

1)co-presence of relevant clinical diseases ;2)previous cardiac events (angina Pectoris or Acute Myocardium Infarct;Cardiac Unbalance;Cardiomyopathy's History ;Cardiac Arrhythmy in treatment;alteration of the cardiac electrical managment which compromised cardiac function or that requires specific treatments;alteration of the cardiac valvular function which compromises the cardiac functionality or that requires specific treatments;cardiomegaly; not controlled hypertension; 3)overexpression of HER2-NEU; 4)previous chemoterapeutic treatments; 5)presence of metabolic scompensate disease or infections.

1)Presenza di rilevanti co-morbidita';2)Storia di rilevante patologia cardiaca(Pregresso episodio di Angina Pectoris o Infarto miocardico acuto;Pregresso episodio di Scompenso Cardiaco;Storia di Cardiomiopatia;Aritmia cardiaca in trattamento;Alterazione della conduzione elettrica cardiaca che comprometta la funzionalita' cardiaca o che richieda trattamenti specifici;Alterazione della funzione valvolare cardiaca che comprometta la funzionalita' cardiaca o che richieda trattamenti specifici;Cardiomegalia;Ipertensione arteriosa non controllata);3)Precedenti trattamenti chemioterapici;4)Tumori mammari Her-2 positivi (IHC 3+ o FISH +);5)Malattie metaboliche scompensate o infezioni in atto.

E.5 End points

E.5.1

Primary end point(s)

safety

sicurezza

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

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Information not present in EudraCT

E.8.1.3

Single blind

Information not present in EudraCT

E.8.1.4

Double blind

Information not present in EudraCT

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Information not present in EudraCT

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	No
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	42
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	42
F.4.2	For a multinational trial
F.4.2.1	In the EEA	42
F.4.2.2	In the whole clinical trial	42

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

2010-11-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-28

P. End of Trial
P.	End of Trial Status	Completed

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