Clinical Trials Register

Summary
EudraCT Number:	2012-000393-35
Sponsor's Protocol Code Number:	GOIM21002
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:	2012-03-30
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

2012-000393-35

A.3

Full title of the trial

a multicenter phase II trial of nab-paclitaxel and capecitabine as first line treatment in Her-2 negative metastatic breast cancer (MBC)

studio di fase II sull'utilizzo di nanoparticle albumin-bound paclitaxel (ABX) in associazione a capecitabina nel trattamento di prima linea del tumore mammario metastatico Her-2 negativo

A.3.1

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

a multicenter phase II trial of nab-paclitaxel and capecitabine as first line treatment in Her-2 neg. metastatic breast cancer

studio di fase II, in pazienti affette da carcinoma della mammella metastatico Her-2 neg. e triple neg., I linea, utilizzando ABX e capecitabina

A.3.2

Name or abbreviated title of the trial where available

protocol GOIM 21002

protocollo GOIM 21002

A.4.1

Sponsor's protocol code number

GOIM21002

A.5.4

Other Identifiers

Name:

numero eudract

Number:

2012-000393-35

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	70126
B.5.3.4	Country	Italy
B.5.4	Telephone number	080/5555448
B.5.5	Fax number	080/5555440
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	No
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	abraxane
D.3.2	Product code	NA
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.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	33069-62-4
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	150
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	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	No
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	xeloda
D.3.2	Product code	NA
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	154361-50-9
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	825
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 breast cancer (MBC) Her-2 negative as first line treatment

carcinoma della mammella metastatico Her-2 neg e triple neg. in trattamento di I linea

E.1.1.1

Medical condition in easily understood language

metastatic breat cancer Her-2, pgr, Er negative

carcinoma della mammella con metastasi con her2, Pgr, Er negativi

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

the efficacy of combination in terms of responce rate; the progression free survival

valutare l'attivitò di nab-paclitaxel (abraxane) in associazione a capecitabina (xeloda), in termini di risposta obiettiva espressa in percentuale; sopravvivenza libera da progressione

E.2.2

Secondary objectives of the trial

overall survival; tolerability and safety

sopravvivenza globale e valutazione del profilo di sicurezza e di tollerabilità dei farmaci utilizzati

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. documented diagnosis of Her-2 neg o triple neg metastatic breast cancer, 2. age > o = 18 years, 3. no prior chemiotherapy for metastatic disease, 4. previous hormonal therapy as adjuvant or as I line treatment is allowed, 5. previous therapy with taxanes is allowed as adjuvant or neoadjuvant treatment if completed from at least 6 months, 6. previous treatment with anthracyclines is not mandatory, 7. PS 0-1, 8. consens informed

1. pazienti affette da documentata malattia mammaria metastatica Her-2 negativo o tripla negativa, 2. età superiore a 18 anni, 3. non precedenti trattamenti chemioterapici per la malattia metastatica, 4. terapia ormonale precedente in adiuvante o come I linea metastatica, 5. assenza di metastasi celebrali, 6. terapia con taxani in adiuvante o neoadiuvante se terminata da almeno 6 mesi, 7. performance status 0-1, precedente trattamento adiuvante con antracicline non è mandatorio, 8. consenso informato scritto

E.4

Principal exclusion criteria

1. documented brain metastases, 2. sensory neuropathy more than grade 1, 3. positive pregnancy test

1. metastasi celebrale documentata, 2. neuropatia sensoriale di grado superiore a 1, 3. test di gravidanza positivo

E.5 End points

E.5.1

Primary end point(s)

1. the efficacy of combination in terms of response rate, 2. the progression free survival

1. valutare l'attivitò di nab-paclitaxel (abraxane)in associazione a capecitabina (xeloda) in termini di risposta obiettiva espressa in percentuale, 2. sopravvivenza libera da progressione

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years

2 anni

E.5.2

Secondary end point(s)

1. overall survival, 2. tolerability and safety

1. sopravvivenza globale, 2. sicurezza e tollerabilità

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

progression free survival, overall survival

sopravvivenza libera da 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

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

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

achievement of objecties

raggiungimento degli obiettivi

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

patients who are unable to understand the text of the information sheet and informed consnt form

pazienti incapaci di comprendere il testo e il significato del foglio informativo e modulo di consenso informato

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)

If paziente decide not to participate in the study, your doctor will discuss with the patient other treatment options available

se la paziente deciderà di non partecipare allo studio, il medico discuterà con la paziente le altre opzioni terapeutiche disponibili

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

2012-02-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-27

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

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