Clinical Trials Register

Summary
EudraCT Number:	2012-000699-40
Sponsor's Protocol Code Number:	BR55-102
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:	2012-05-28
Trial results	View 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

2012-000699-40

A.3

Full title of the trial

A Study of BR55 in Contrast Enhanced Ultrasound Imaging in Patients with Ovarian and Breast Cancer.

Ecografia con BR55 in pazienti con tumore della mammella e dell'ovaio

A.3.1

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

A Study of BR55 in Contrast Enhanced Ultrasound Imaging in Patients with Ovarian and Breast Cancer.

Ecografia con BR55 in pazienti con tumore della mammella e dell’ovaio

A.3.2

Name or abbreviated title of the trial where available

Exploratory of BR55 in Ovarian and Breast Cancer

Studio di BR55 sul tumore mammario e ovarico

A.4.1

Sponsor's protocol code number

BR55-102

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	BRACCO IMAGING
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bracco Imaging spa
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	Bracco Imaging spa
B.5.2	Functional name of contact point	Global Medical & Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Via XXV Aprile 4
B.5.3.2	Town/ city	San Donato Milanese
B.5.3.3	Post code	20097
B.5.3.4	Country	Italy
B.5.4	Telephone number	02 21772324
B.5.5	Fax number	02 21772784
B.5.6	E-mail	paola.pianezzola@bracco.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	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	BR55
D.3.2	Product code	BR55
D.3.4	Pharmaceutical form	Suspension for injection
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	BR55
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25.4
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

Patients with ovarian or breast cancer.

Pazienti affette da tumore alla mammella o all'ovaio.

E.1.1.1

Medical condition in easily understood language

Patients with ovaries or breast cancer.

Pazienti affette da tumore alla mammella o all'ovaio.

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

To assess ultrasound imaging results with BR55 in the detection of cancer lesions in patients with ovarian cancer or ovarian mass or patient with breast cancer using histology as the truth standard for the presence/absence of malignant lesions.

Valutare i risultati dell’indagine ecografica con BR55 in pazienti con tumore o massa ovarica ed in pazienti con tumore della mammella, utilizzando l’istologia quale standard di riferimento per la presenza/assenza di lesioni maligne.

E.2.2

Secondary objectives of the trial

To assess the binding of BR55 to VEGFR2 during contrast-enhanced ultrasound and compared with immunohistochemistry. To obtain safety data for BR55. To explore the optimum dose of BR55 in terms of the detection of cancer lesions in patients with ovarian cancer or ovarian mass or patient with breast cancer.

Valutare la capacita’ di BR55 di legarsi al recettore vascolare per la neoangiogenesi (VEGFR2) durante l’indagine ecografica con contrasto,utilizzando l’analisi immunoistochimica quale standard di riferimento. Raccogliere dati sulla sicurezza di BR55. Valutare la dose ottimale di BR55 che permette di visualizzare le zone tumorali in pazienti con tumore dell’ovaio o della mammella.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

For all Participants: 1. Signed Informed Consent obtained. For ovarian Patients: 1. Post menopausal female; 2.No menstrual period for at least one year; 3. Age ≥18 years; 4. Established or suspected ovarian cancer diagnosis based on the following criteria: ovarian mass not greater than 10 cm in size / with suspected malignant solid component confirmed by diagnostic imaging / with or without extra-ovarian cancer spread including ascites and-or omental caking and-or peritoneal nodules/Scheduled to undergo ovarian surgery for primary cancer or ovarian mass within 30 days after enrollment. For breast Patients: 1. Female; 2. Age ≥ 18 years; 3. Established or suspected breast cancer diagnosis based on diagnostic imaging (mammography, ultrasound, and/or MRI); 4. Scheduled to undergo primary breast cancer surgery or large core biopsy of the breast within 30 days after enrollment.

Dovranno essere rispettati i seguenti criteri di inclusione: éer tutte le partecipanti: 1. Abbiano fornito consenso informato scritto; 2. Pazienti con patologia ovarica; 3. Donne in post menopausa; 4. Assenza di ciclo mestruale da almeno 1 anno; 5. Età ≥18 anni; 6. Diagnosi certa o sospetta di tumore ovarico in base ai seguenti criteri: - massa ovarica di dimensioni non superiori a 10cm - con sospetta componente solida maligna evidenziata da indagini di imaging diagnostico -con o senza diffusione extra ovarica (includendo ascite e/o carcinosi peritoneale e/o noduli peritoneali); 7. Programmata per essere sottoposta ad intervento chirurgico per tumore primario dell’ovaio o massa ovarica entro 30 giorni dall’arruolamento; Per le pazienti con patologia mammaria: 1. Sesso femminile; 2. Età ≥ 18 anni; 3. Diagnosi certa o sospetta di tumore mammario in base ad indagini di imaging diagnostico (mammografia, ecografia e/o RM); 4. Programmata per essere sottoposta ad intervento chirurgico per tumore mammario primario o biopsia percutanea estesa della mammella entro 30 giorni dall’arruolamento.

E.4

Principal exclusion criteria

Exclude a patient from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed: Has a body weight ≥95 kg Has undergone prior systemic therapy for ovarian or breast cancer Has history of concurrent malignancy Has history of any clinically unstable cardiac condition including class III/IV congestive heart failure Has known right to left cardiac shunt, bidirectional or transient Has had any severe cardiac rhythm disorders within 7 days prior to enrolment Is known to suffer from stable angina pectoris and/or has suspected or proven coronary disease Has severe pulmonary hypertension (pulmonary artery pressure >90mmHg) or uncontrolled systemic hypertension and/or respiratory distress syndrome Has open and/or non-healing wounds in the chest, abdomen and pelvis Has other systemic vascular abnormalities associated with neovascularization, such as macular degeneration, that in the opinion of the investigator could significantly affect the ability to evaluate the effects of BR55. Is unable to comply with study protocol requirements for any reason. Is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment Has previously been enrolled in and completed this study Has any known allergy to one or more ingredients of the Investigational Product or to any other contrast media It is determined by the Investigator that the patient is clinically unsuitable for the study Ovarian Patients Additional exclusion criteria: Major surgery, including laparoscopic surgery, within 3 months prior to enrolment Breast Patients: Additional exclusion criteria: Pregnancy or breastfeeding. Exclude the possibility of pregnancy: o By testing on site at the institution (serum βHCG) within 24 hours prior to the start of the IMP administration o By surgical history (e.g. tubal ligation or hysterectomy) Post menopausal within a minimum one year without menses History of significant acute or chronic breast abnormalities (e.g. infection or trauma) in the breast of interest. History of minor (e.g., fine-needle aspiration, needle core biopsy, vacuum-assisted core biopsy, cyst aspiration, or other similar procedures) or major (e.g., mastectomy, breast-conserving surgery, implants, open surgical biopsy, breast radiotherapy, or other similar procedures) procedures in the breast of interest.

La participazione a questo studio è consentita solo se tutti i criteri di inclusione sono rispettati e se nessuna delle seguenti condizioni è presente: Gravidanza) o allattamento. Escludere la gravidanza con: • test serico βHCG entro le 24 ore precedenti alla somministrazione di BR55storia pregressa di isterectomia o legatura delle tube • presenza di menopausa definita come assenza di mestruazioni da almeno un anno Peso corporeo ≥95 kg Precedente terapia sistemica per tumore ovarico o mammario Anamnesi positiva per patologia maligna concomitante Anamnesi positiva per patologia cardiaca clinicamente instabile, inclusa una condizione di insufficienza cardiaca congestizia di classe III/IV Presenza di shunt destro-sinistro, transitorio o bidirezionale Anamnesi positiva per alterazioni severe del ritmo cardiaco nei 7 giorni precedenti l’arruolamento Anamnesi positiva per angina pectoris stabile e/o malattia coronarica nota o sospetta Presenza di ipertensione polmonare severa (pressione arteriosa polmonare >90mmHg) o ipertensione sistemica non controllata e/o sindrome da distress respiratorio Presenza di ferite in sede toracica, addominale e pelvica aperte e/o non cicatrizzate Presenza di patologie vascolari sistemiche associate a neoangiogenesi, quali ad es degenerazione maculare, che a giudizio dello sperimentatore possono influire significativamente sulla capacità di valutare gli effetti di BR55 Incapacità per qualsiasi ragione a seguire le istruzioni del protocollo Partecipazione in atto o pregressa ad un altro studio clinico con impiego di un prodotto sperimentale nei 30 giorni precedenti l’arruolamento Precedente arruolamento nello studio in oggetto, con completamento dello studio stesso Presenza di allergie note ad uno o più ingredienti del prodotto sperimentale o storia di allergie ad altri mezzi di contrasto Lo Sperimentatore ritenga che la paziente non sia clinicamente idonea per lo studio Pazienti con patologia ovarica - ulteriore criterio di esclusione: Chirurgia maggiore, inclusa la chirurgia laparoscopica, nei 3 mesi precedenti l’arruolamento. Pazienti con patologia mammaria - ulteriori criteri di esclusione: Anamnesi positiva per patologie mammarie significative acute o croniche (es. flogosi o lesioni traumatiche) a carico della mammella sede della lesione in esame. Anamnesi positiva per procedure invasive minori (es. ago-biopsia, microbiopsia percutanea, o altre procedure similari) o maggiori (es. mastectomia, chirurgia conservativa, protesi mammarie, biopsia chirurgica, radioterapia della regione mammaria, o altre procedure similari) a carico della mammella sede della lesione in esame.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

72 hours after the administration of BR55.

72 ore dal momento della somministrazione di BR55.

E.5.2

Secondary end point(s)

Valutare la capacita’ di BR55 di legarsi al recettore vascolare per la neoangiogenesi (VEGFR2) durante l’indagine ecografica con contrasto, utilizzando l’analisi immunoistochimica quale standard di riferimento. Raccogliere dati sulla sicurezza di BR55. Valutare la dose ottimale di BR55 che permette di visualizzare le zone tumorali in pazienti con tumore dell’ovaio o della mammella.

E.5.2.1

Timepoint(s) of evaluation of this end point

72 hours after the administration of BR55.

72 ore dal momento della somministrazione di BR55.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

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

Yes

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

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)

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

When all diagnosis of the enrolled patients are confirmed by histophatology.

Quando tutte le diagnosi delle pazienti arruolate vengono confermate dall'esame istologico.

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-05-28.

Yes

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)

No treatment or care after a subject has ended her participation in the trial are planned but the standard therapies scheduled for her pathology by the hospital's physicians.

Non sono previsti programmi per il trattamento o l'assistenza per le pazienti al termine della loro partecipazione allo studio se non le le terapie standard previste dalla struttura ospedaliera per la loro patologia.

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

2012-07-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-04-02

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