Clinical Trials Register

Summary
EudraCT Number:	2016-001253-41
Sponsor's Protocol Code Number:	GOIM16002-CABONESTUDY
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:	2021-02-09
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

2016-001253-41

A.3

Full title of the trial

Impact of cabazitaxel on metastatic bone disease in patients with castration resistant prostate cancer previously treated with docetaxel

Impatto di cabazitaxel sulle metastasi ossee in pazienti affetti da neoplasia prostatica resistente alla castrazione pretrattati con docetaxel.
Caba on Bone Disease, CABONE Study

A.3.1

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

Impact of cabazitaxel on metastatic bone disease in prostate cancer

Impatto di cabazitaxel sulle metastasi ossee in pazienti affetti da cancro della prostata

A.3.2

Name or abbreviated title of the trial where available

CABONE STUDY

STUDIO CABONE

A.4.1

Sponsor's protocol code number

GOIM16002-CABONESTUDY

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	GRUPPO ONCOLOGICO DELL'ITALIA 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	Sanofi S.p.a
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 dell'Italia Meridionale ( GOIM)
B.5.2	Functional name of contact point	Clinical Trial Center
B.5.3	Address:
B.5.3.1	Street Address	Viale J. Kennedy 50
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	3409404826
B.5.5	Fax number	0882412792
B.5.6	E-mail	trialsgoim@gmail.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	JEVTANA - 60MG-CONCENT. E SOLV.PER SOLUZ. PER INFUSIONE-USO ENDOVENOSO -CONCENT.:FLACONC.(VETRO)SOLV.: FLACONC.(VETRO)-CONCENT.:1.5ML SOLV.:4.5ML-1FLAC.+1FLAC.
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS GROUPE
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.3.1	Product name	CABAZITAXEL
D.3.2	Product code	[IMP1]
D.3.4	Pharmaceutical form	Powder 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	CABAZITAXEL
D.3.9.2	Current sponsor code	IMP1
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	25
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

1. Histologically or cytologically confirmed adenocarcinoma of prostate that is resistant to hormone therapy and previously treated with a docetaxel containing regimen.

Adenocarcinoma prostatico confermato istologicamente o citologicamente resistente alla ormonoterapia e trattato precedentemente con una terapia contenente docetaxel.

E.1.1.1

Medical condition in easily understood language

Prostate cancer that is resistant to hormone therapy and previously treated with a docetaxel containing regimen.

Tumore della prostata non rispondente a ormonoterapia e trattato precedentemente con una terapia contenente docetaxel

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10001198
E.1.2	Term	Adenocarcinoma of the prostate metastatic
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Bone Progressione Free Survival

Sopravvivenza libera da progressione ossea

E.2.2

Secondary objectives of the trial

Analysis of effect on bone turnover markers, time to bone pain progression, bone pain response;

Valutare l’effetto di Cabazitaxel sui marcatori di turnover osseo e sulle variazioni dell’intensità del dolore osseo in corso di terapia

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

Other types of substudies
Specify title, date and version of each substudy with relative objectives: -Ancillary Study on " Bone Biomarkers"
- vs 1.0, 01 Sept 2016
-We consider a real medical need to investigate the effects of cabazitaxel on bone disease, bone turnover and on the bone related quality of life of cabazitaxel in CRPC with skeletal involvement alone.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: - Sottostudio sui biomarcatori ossei
- vs 1.0, 01 Settembre 2016
- Studiare mediante uno specifico studio prospettico interventistico gli effetti di cabazitaxel sulla malattia ossea, sul turnover osseo e sugli eventi scheletrici che impattano sulla qualità della vita in pazienti affetti da CRPC con solo coinvolgimento osseo

E.3

Principal inclusion criteria

1. Histologically or cytologically confirmed adenocarcinoma of prostate that is resistant to hormone therapy and previously treated with a docetaxel containing regimen
2.At least one measurable bone metastasis showed with bone scan and radiological confirmed. A confirmed diagnosis of bone metastases to bone scanning will require a second imaging modality (CT, MRI, or plain radiograph)
3.Life expectancy > 3 months
4.Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2

1. Adenocarcinoma prostatico confermato istologicamente o citologicamente resistente alla ormonoterapia e trattato precedentemente con una terapia contenente docetaxel
2.Almeno una metastasi ossea misurabile osservata attraverso scintigrafia ossea. La diagnosi di metastasi deve essere confermata anche attraverso l'utilizzo di una seconda modalità di radioimaging (TC o rRx)
3.Aspettativa di vita superiore a 3 mesi
4.Performance status (ECOG) 0 – 2

E.4

Principal exclusion criteria

1. History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
2.Any previous hormonal therapy with abiraterone, enzalutamide, TAK 700 provided in post docetaxel setting. Abiraterone pre-docetaxel is allowed only if the last administration is more than 3 months before the study inclusion

1.Storia di metastasi viscerali valutate mediante TC addome-pelvi o Rx entro 8 settimane dall’inclusione nello studio
2.Qualsiasi tipo di radioterapia ossea nel corso dei due mesi precedenti all'inclusione nello studio
3.Chirurgia, chemioterapia o qualsiasi altra terapia oncologica nelle 4 settimane precedenti all'arruolamento
4.qualsiasi precedente terapia ormonale con abiraterone, enzalutamide, TAK 700 somministrata dopo la terapia con docetaxel.

E.5 End points

E.5.1

Primary end point(s)

Bone (Skeletal) PFS

Progressione libera da malattia

E.5.1.1

Timepoint(s) of evaluation of this end point

Whole duration of the study

Durata dell'intero studio

E.5.2

Secondary end point(s)

1. Analysis of effect on Bone turnover markers

1.Analisi degli effetti sui turnover dei marcatori ossei

E.5.2.1

Timepoint(s) of evaluation of this end point

Whole duration of the study

Durata dell'intero studio

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

E.6.4

Safety

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

Quality of life

Qualità della vita

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

Lo studio si pone l'obiettivo di valutare gli effetti di cabazitaxel sulla malattia ossea, sul turn

We consider a real medical need to investigate the effects of cabazitaxel on bone disease, bone turn

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

Information not present in EudraCT

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

LVLS

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

107

F.2 Gender

F.2.1

Female

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

107

F.4.2

For a multinational trial

F.4.2.1

In the EEA

107

F.4.2.2

In the whole clinical trial

107

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)

Patients will receive better therapy according to medical decision

Il paziente riceverà le terapie più adeguate previste per la patologia in questione.

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

2018-03-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-08-31

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

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