Clinical Trials Register

Summary
EudraCT Number:	2011-002009-31
Sponsor's Protocol Code Number:	MO25757
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:	2012-08-31
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

2011-002009-31

A.3

Full title of the trial

A single arm open label multicentre extension study of bevacizumab in patients with solid tumours on study treatment with bevacizumab at the end of a F. Hoffmann-La Roche and/or Genentech sponsored study.

Studio di estensione multicentrico, in aperto e a braccio singolo sull'uso di bevacizumab in pazienti con neoplasie solide trattati con bevacizumab sperimentale, al termine di uno studio sponsorizzato da F. Hoffmann-La Roche e/o Genentech.

A.3.1

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

A multicentre extension study of bevacizumab in patients with solid tumours on study treatment with bevacizumab, at the end of a F. Hoffmann-La Roche and/or Genentech sponsored study.

Studio multicentrico di estensione con bevacizumab, in pazienti con neoplasie solide trattati con bevacizumab sperimentale, al termine di uno studio sponsorizzato da F. Hoffmann-La Roche.

A.4.1

Sponsor's protocol code number

MO25757

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. HOFFMANN - LA ROCHE LTD.
B.1.3.4	Country	Switzerland
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	F. HOFFMANN - LA ROCHE LTD.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ROCHE S.p.A.
B.5.2	Functional name of contact point	HEAD OF CLINICAL OPERATIONS
B.5.3	Address:
B.5.3.1	Street Address	VIALE G.B. STUCCHI 110
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	039-2475070
B.5.5	Fax number	039-2475085
B.5.6	E-mail	italy.info_cta@roche.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	AVASTIN
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Concentrate 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	BEVACIZUMAB
D.3.9.1	CAS number	216974-75-3
D.3.9.2	Current sponsor code	RO4876646
D.3.9.4	EV Substance Code	SUB16402MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Anticorpo monoclonale ricombinante umanizzato.

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

Solid tumours.

Tumori solidi.

E.1.1.1

Medical condition in easily understood language

Cancer.

Cancro.

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	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10049280
E.1.2	Term	Solid tumour
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10065143
E.1.2	Term	Malignant solid tumour
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 provide continued bevacizumab therapy as single agent or in combination with an anti-cancer drug to patients with cancer, who were previously enrolled in a F. Hoffmann-La Roche (Roche)/ Genentech sponsored bevacizumab study (i.e. the Parent, P-trial) and who derived benefit from the therapy administered in the P-trial - To collect safety data with regard to long-term administration of bevacizumab

- Fornire il trattamento continuativo con bevacizumab in monoterapia o in associazione a un farmaco antitumorale a pazienti oncologici precedentemente arruolati in uno studio su bevacizumab sponsorizzato da F. Hoffmann-La Roche (Roche) e/o Genentech (lo studio capostipite o “studio P” dall'inglese Parent) e che hanno tratto beneficio dalla terapia somministrata nello studio P. - Raccogliere dati sulla sicurezza della somministrazione a lungo termine di bevacizumab.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent prior to any study-specific procedure. 2. Patient is treated with bevacizumab at the end of the Roche/Genentech sponsored P-trial and continues to have benefit as judged by the investigator 3. Eligible for continuation of bevacizumab treatment at the end of the Parent-trial, according to Parent-trial protocol 4. Able to comply with the Extension-trial protocol MO25757 5. Female patients should not be pregnant or breastfeeding. 6. Female patients of childbearing potential/fertile male patients must use a highly effective contraceptive method during the Extension-trial and for a period of at least 6 months following the last administration of Extension-trial drug(s).

1. Prima di effettuare qualunque procedura prevista dallo studio si dovrà ottenere la firma del modulo di consenso informato 2. Il paziente è in trattamento con bevacizumab al termine dello studio P sponsorizzato da Roche/Genentech e continua a trarne beneficio secondo il parere dello sperimentatore 3. È idoneo a proseguire il trattamento con bevacizumab al termine dello studio P, ai sensi del protocollo dello studio P 4. È in grado di rispettare i requisiti del protocollo dello studio E (MO25757) 5. Le pazienti di sesso femminile non devono essere in gravidanza o in allattamento. Le pazienti di sesso femminile potenzialmente fertili (< 2 anni dall'ultima mestruazione o non sottoposte a sterilizzazione chirurgica) devono utilizzare un metodo contraccettivo altamente efficace (metodi di controllo delle nascite consentiti, con un tasso di insuccesso inferiore all'1% all'anno sono contraccettivi impiantabili, iniettabili, contraccettivi orali combinati, IUD [solo spirali ormonali], astinenza sessuale o partner vasectomizzato) durante lo studio E e per un periodo di almeno 6 mesi dopo l'ultima somministrazione del/i farmaco/i dello studio E. Le pazienti di sesso femminile con utero intatto (se non amenorreiche da almeno 24 mesi) devono presentare un test di gravidanza sul siero negativo prima di ricevere il primo trattamento in studio (vedere paragrafo 5.4.1). 6. I pazienti di sesso maschile potenzialmente fertili devono utilizzare un metodo contraccettivo altamente efficace (metodi di controllo delle nascite consentiti, con un tasso di insuccesso inferiore all'1% all'anno: partner femminili che utilizzano contraccettivi impiantabili, iniettabili, orali combinati, IUD [solo spirali ormonali], astinenza sessuale o precedente vasectomia) durante lo studio E e per un periodo di almeno 6 mesi dopo l'ultima somministrazione del/i farmaco/i dello studio E.

E.4

Principal exclusion criteria

1. Evidence of disease progression assessed according to Parent-trial protocol during the screening phase for this Extension-trial 2. Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation. 3. A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the Parent-trial. 4. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s) or puts the patient at high risk for treatment related complications.

1. Evidenza di progressione della malattia, determinata in base al protocollo dello studio P durante la fase di screening per questo studio E. 2. Evidenza di qualsiasi evento avverso potenzialmente attribuibile a bevacizumab, per cui l'etichettatura locale raccomandi la sospensione permanente. 3. Interruzione del trattamento con bevacizumab superiore ai 42 giorni dall'ultima somministrazione di bevacizumab nello studio P. 4. Evidenza di qualsiasi altra malattia, disfunzione neurologica o metabolica, riscontro all’esame obiettivo o riscontro negli esami di laboratorio che facciano ragionevolmente sospettare una malattia o una condizione patologica che controindichi l’impiego di un farmaco in fase di sperimentazione, o che ponga il paziente ad alto rischio di sviluppare complicanze correlate al trattamento.

E.5 End points

E.5.1

Primary end point(s)

Safety data (AE grade ≥3 related to bevacizumab, SAEs, cause of deaths)

Dati sulla sicurezza (AE di grado >=3 correlati a bevacizumab, SAEs, causa di morte).

E.5.1.1

Timepoint(s) of evaluation of this end point

There will be a safety interim analysis approximately 3 years after the enrolment of the first patient in this Extension-trial. A final analyses will be done at the trial end.

Sarà effettuata una interim analisi sulla sicurezza circa tre anni dopo l'arruolamento del primo paziente in questo studio di estensione. L'analisi finale verrà effettuata alla conclusione della sperimentazione.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Australia

Canada

China

Hong Kong

Israel

Korea, Republic of

Mexico

Russian Federation

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

Study MO25757 will end 30 days after the last patient stops bevacizumab treatment.

Lo studio MO25757 terminera' 30 giorni dopo l'interruzione del trattamento con bevacizumab dell'ulitmo paziente.

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

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:

250

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

250

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.4.2

For a multinational trial

F.4.2.1

In the EEA

250

F.4.2.2

In the whole clinical trial

500

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)

MO25757 is an extension trial designed to allow benefitting patients to continue treatment with bevacizumab. All patients will have stopped bevacizumab treatment at the end of study MO25757. Decisions concerning the care of the patient will be left with the patients' treating physician after completion of this extension trial.

MO25757 e' uno studio di estensione disegnato per permettere, ai pazienti che ne hanno beneficio, di continuare il trattamento con bevacizumab. Tutti i pazienti avranno terminato il trattamento con bevacizumab alla fine dello studio MO25757. Le decisioni circa le terapie dei pazienti al completamento della sperimentazione saranno lasciate al medico che ha in cura il paziente.

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

2012-04-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-05

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

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