Clinical Trials Register

Summary
EudraCT Number:	2012-001325-28
Sponsor's Protocol Code Number:	GOIM21003
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:	2012-07-23
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

2012-001325-28

A.3

Full title of the trial

non-Pegylated liposomal doxrubicina (Myocet) + cyclophosphamide versus non pegylated liposomal doxorubicin (Myocet) + metronomic cyclophosphamide in metastatic breast cancer-a multicenter randomized phase II

DOXORUBICINA LIPOSOMIALE NON PEGILATA (MYOCET)+CICLOFOSFAMIDE VS DOXORUBICINA LIPOSOMIALE NON PEGILATA (MYOCET)+CICLOFOSFAMIDE METRONOMICO NEL CANCRO MAMMARIO METASTATICO-STUDIO MULTICENTRICO RANDOMIZZATO DI FASE II

A.3.1

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

Phase II study in patients suffering from metastatic breast cancer Her2neg, The Line, randomized (1:1) with two arms.

studio di fase II, in paziente affette da carcinoma della mammella metastatico Her2neg, I linea, randomizzato (1:1)a due bracci.

A.3.2

Name or abbreviated title of the trial where available

protocol GOIM 21003

protocollo GOIM 21003

A.4.1

Sponsor's protocol code number

GOIM21003

A.5.4

Other Identifiers

Name:

numero eudract

Number:

2012-001325-28

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	GOIM GRUPPO ONCOLOGICO MERIDIONALE
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	studio no-profit
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	gruppo oncologico italia meridionale
B.5.2	Functional name of contact point	centro dati GOIM (data manager)
B.5.3	Address:
B.5.3.1	Street Address	via delle forze armate, 16
B.5.3.2	Town/ city	bari
B.5.3.3	Post code	70124
B.5.3.4	Country	Italy
B.5.4	Telephone number	080/5555448
B.5.5	Fax number	080/5555438
B.5.6	E-mail	colucci@goim.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.2.1.2	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	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	50-18-0
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	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	Yes
D.3.11.13.1	Other medicinal product type	chemioterapico
D.IMP: 2
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	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.3.9.2	Current sponsor code	myocet
D.3.9.3	Other descriptive name	myocet
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg/h milligram(s)/kilogram/hour
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	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

patients wiyh metastatic breast cancer her2 negative first line treatment

pazienti affette da carcinoma mammario metastatico Her2negativo in trattamento di I linea

E.1.1.1

Medical condition in easily understood language

breast metastatic cancer4 Her2 negative

cancro alla mammella con metastasi Her2 negativo, in terapia di I linea

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	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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

evaluate the performance in terms of response rates (RR) and quality of life

valutare l'attività in termini di percentuali di risposte (RR) e di qualità di vita

E.2.2

Secondary objectives of the trial

evaluate time to progression (PFS) and overall survival (OS)

valutare il tempo alla progressione (PFS)e la sopravvivenza globale (OS)

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

LIFE QUALITY:
Vers:N.1
Date:2012/03/07
Title:questionnaire FACT-B
Objectives:quality of life

QUALITA DELLA VITA:
Vers:N.1
Data:2012/03/07
Titolo:QUESTIONARIO FACT-B
Obiettivi:qualità di vita

E.3

Principal inclusion criteria

• histologically proven breast carcinoma Her-2 negative • Age 18-75 years • State of validity (WHO) ≤ 2 • Disease stage IIIB / IV with the presence of at least one measurable lesion unidimensionalmente • Any previous adjuvant / neoadjuvant chemotherapy completed at least 1 year • Any previous adjuvant hormone therapy or in advanced disease with documented progression • Possible previous RT including not more than 30% of the skeleton containing bone marrow and terminated by at least 4 weeks • Adequate bone marrow function (GB 4.000/mm3 ≥, ≥ 2.000/mm3 neutrophils, platelets ≥ 100.000/mm3), hepatic (bilirubin ≤ 1.5mg%), renal (creatinine ≤ 1.2mg%) • Negative pregnancy test (urine or serum) made within 7 days prior to entry into the study in women of childbearing age, these patients should take effective non-hormonal contraception for the duration of treatment • The pre-manopausali patients with endocrine responsive disease can be treated with LH-RH analogue, the measurement of any ovarian activity with serum tests should be performed only once at baseline study. • Geographical Accessibility for follow-up • Written Informed Consent

•carcinoma mammario istologicamente accertato Her-2 negativo •Età 18-75 anni •Stato di validità (WHO) ≤ 2 •Malattia in stadio IIIB/IV con presenza di almeno una lesione misurabile unidimensionalmente •Eventuale precedente chemioterapia adiuvante e/o neoadiuvante terminata da almeno 1 anno •Eventuale precedente ormonoterapia adiuvante o in malattia avanzata con progressione documentata •Eventuale precedente RT includente non oltre il 30% dello scheletro contenente midollo osseo e terminata da almeno 4 settimane •Adeguata funzionalità midollare (GB≥ 4.000/mm3, neutrofili ≥ 2.000/mm3; piastrine ≥ 100.000/mm3), epatica (bilirubina ≤ 1.5mg%), renale (creatininemia ≤1.2mg%) •Test di gravidanza negativo (urine o siero) effettuato nei 7 giorni precedenti l’entrata in studio nelle donne in età fertile; tali pazienti dovranno adottare efficaci misure contraccettive non ormonali per tutta la durata del trattamento •Le pazienti pre-manopausali con malattia endocrino responsiva possono essere trattate con LH-rh analogue, la misurazione con test sierici dell’eventuale attività ovarica va effettuata una sola volta al momento dell’arruolamento dello studio. •Accessibilità geografica per follow-up •Consenso Informato scritto

E.4

Principal exclusion criteria

• • Previous chemotherapy for metastatic disease or concomitant therapy with hormonal agents or biotherapy • Previous adjuvant / neoadjuvant chemotherapy with attainment of the maximum cumulative dose of Adriamycin of 450 mg / sqm and epirubicin of 900 mg / sqm. • symptomatic brain metastases • psychological disorders precluding the obtaining of informed consent • Other cancers (except basal or squamous cell skin cancers and carcinoma in situ of the cervix, if adequately treated) • LVEF <50% determined by echocardiogram or MUGA scan • Patients who are pregnant • uncontrolled arterial hypertension (systolic ≥ 150 mmHg and / or diastolic ≥ 100 mmHg) • Cardiovascular disease clinically active (eg acute myocardial infarction within 6 months prior to enrollment in this study, NYHA Class II CHF, severe cardiac arrhythmia, which may require medical treatment during the study and could interfere with the regularity of treatment, or is not controlled by medical treatment) • Leukocytes <4000/mmc, neutrophils <2000/mmc, platelets <100000/mmc • Impaired renal function (creatinine  1.25 times normal) or hepatic (GOT or GPT  1.25 times the normal values, unless the disease is not due to liver metastases) • Concomitant treatment with other experimental drugs

•Precedente chemioterapia per malattia metastatica o concomitante terapia con agenti ormonali o bioterapie •Precedente chemioterapia adiuvante e/o neoadiuvante con raggiungimento del dosaggio cumulativo massimo consentito di Adriamicina pari a 450 mg/mq e Epirubicina pari a 900 mg/mq. •Metastasi cerebrali sintomatiche •Malattie psichiche precludenti l’ottenimento del consenso informato •Altre neoplasie ( ad eccezione del carcinoma cutaneo baso o spinocellulare e il carcinoma in situ della cervice, purché adeguatamente trattati) •LVEF<50% determinato con ecocardiogramma o MUGA scan •Pazienti in gravidanza •Ipertensione arteriosa incontrollata (sistolica ≥ 150 mmHg e/o diastolica ≥ 100 mmHg) •Malattia cardiovascolare clinicamente attiva (ad esempio un infarto acuto del miocardio nei 6 mesi precedente l’arruolamento in studio, CHF NYHA Classe II, aritmia cardiaca severa che possa richiedere un trattamento medico durante lo studio e possa interferire con la regolarità del trattamento stesso, o che non sia controllata dal trattamento medico) •Leucociti < 4000/mmc, neutrofili < 2000/mmc, piastrine < 100000/mmc •Alterazioni della funzione renale (Creatininemia  1.25 volte i valori normali) o epatica (GOT o GPT  1.25 volte i valori normali, a meno che la patologia non sia dovuto a metastasi epatiche) •Trattamento concomitante con altri farmaci sperimentali

E.5 End points

E.5.1

Primary end point(s)

evaluate the performance in terms of response rates (RR) and quality of life

valutare l'attività in termini di percentuali di risposte (RR) e di qualità di vita

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years

2 anni

E.5.2

Secondary end point(s)

assess time to progression (PFS) and overall survival (OS)

valutare il tempo alla progressione (PFS)e la sopravvivenza globale (OS)

E.5.2.1

Timepoint(s) of evaluation of this end point

2 years

2 anni

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

Yes

E.6.13.1

Other scope of the trial description

activities in terms of responses, quality Add life, time to progression, overall survival

attività in termini di risposte, qualitò di vita,tempo alla progressione, sopravvivenza globale

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

Yes

E.8.2.3.1

Comparator description

- Stesso farmaco ad altro dosaggio

- same IMP used at different dosage

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

The objective of this study is to verify if the weekly administration of Myocet and metronomic endoxan deserves validation in a larger series.

l'obiettivo dello studio è quello di verificare se la somministrazione settimanale di myocet ed endoxan metronomico merita una validazione in una casistica più ampia.

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

Number of subjects for this age range:

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

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

Yes

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

PERSONS INCAPABLE OF UNDERSTANDING THE TEXT AND THE MEANING OF PACKAGE INFORMATION

SOGGETTI INCAPACI DI COMPRENDERE IL TESTO E IL SIGNIFICATO DEL FOGLIETTO INFORMATIVO

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

110

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)

adherence to the research protocol is voluntary and may be withdrawn at any time. If the patient decides not to participate, this will not affect that it will continue to receive assistance

l'adesione al protocollo di ricerca è volontaria e potrà essere ritirata in qualsiasi momento. Qualora la paziente decidesse di non prendervi parte, questo non influirà sull'assistenza che continuerà a ricevere

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

2012-07-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-29

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

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