Clinical Trials Register

Summary
EudraCT Number:	2017-001591-35
Sponsor's Protocol Code Number:	ASST-ONCO-CABAC2017
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:	2021-09-06
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

2017-001591-35

A.3

Full title of the trial

Multicenter, prospective, non-randomized, phase II trial designed to evaluate the activity of Cabazitaxel in patients with advanced Adreno-Cortical- Carcinoma progressing after previous chemotherapy lines

A.3.1

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

Multicenter, prospective, non-randomized, phase II trial designed to evaluate the activity of Cabazitaxel in patients with advanced Adreno-Cortical-

Studio multicentrico, prospettico, non randomizzato, di fase II volto a valutare l’attività di Cabazitaxel in pazienti affetti da carcinoma corticosurrenale avanzato in progressione dopo precedenti linee di chemioterapia citotossica

A.3.2

Name or abbreviated title of the trial where available

CABaCC

A.4.1

Sponsor's protocol code number

ASST-ONCO-CABAC2017

A.5.4

Other Identifiers

Name:

CABaCC

Number:

CABaCC

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	AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
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	AIRC
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	SANOFI -fornitura gratuita farmaco
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	ASST S pedali civili di brescia
B.5.2	Functional name of contact point	coordinamento ricerca clinica
B.5.3	Address:
B.5.3.1	Street Address	p.le spedali civili 1
B.5.3.2	Town/ city	brescia
B.5.3.3	Post code	25123
B.5.3.4	Country	Italy
B.5.4	Telephone number	0303996581
B.5.5	Fax number	0303996125
B.5.6	E-mail	coordinamento.ricerca@asst-spedalicivili.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.2.1.1.1	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	JEVTANA
D.3.2	Product code	[cabazitaxel]
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.3.11 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

Histologically confirmed diagnosis of ACC
Locally advanced or metastatic disease not amenable to radical surgery resection

Diagnosi istologica di carcinona cortico-surrenale (ACC) Malattia localmente avanzata o metastatica non suscettibile di resezione chirurgica radicale

E.1.1.1

Medical condition in easily understood language

diagnosis of ACC

carcinona cortico-surrenale

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10061588
E.1.2	Term	Adrenal neoplasm
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 the clinical benefit as measured by a non progressing rate after 4 months of the cabazitaxel in patients with locally advanced or metastatic ACC who progressed after cytotoxic therapy.

Valutare il beneficio clinico misurato come tasso di non progressione di malattia (risposta obiettiva + stabilizzazione di malattia) dopo 4 mesi di trattamento con cabazitaxel in pazienti affetti da carcinoma cortico surrenalico localmente avanzato o metastatico progredito dopo terapia citotossica.

E.2.2

Secondary objectives of the trial

• Assessment of Objective Response Rates (ORR), evaluated by RECIST criteria
• Assessment of hormone response
• Assessment of overall survival, defined as the time from the date of the study start to
date of death due to any cause
• Assessment of quality of life by EORTC QLQ-C30
• Assessment of toxicity, evaluated by NCI CTCAE V4.03 criteria.

• Valutazione del tasso di risposta obiettivo (ORR o Objective Response Rates) mediante i criteri RECIST
• Valutazione della risposta ormonale
• Valutazione della sopravvivenza globale, definito come il tempo intercorrente dalla data d’inizio dello studio alla data di decesso dovuta ad una qualsiasi causa
• Valutazione della qualità della vita mediante il questionario EORTC QLQ-C30
• Valutazione della tossicità mediante i criteri WHO

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: cabazitaxel pharmacokinetics

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: valutazione del profilo farmacocinetico di cabazitaxel dei pazienti che non hanno ricevuto mitotane durante la terapia con cabazitaxel sarà comparato con quello di coloro che non avranno potuto sospendere il farmaco per la necessità di controllare l’ipersecrezione ormonale.

E.3

Principal inclusion criteria

• Histologically confirmed diagnosis of ACC
• Locally advanced or metastatic disease not amenable to radical surgery resection
• Radiologically monitorable disease
• Progressing disease after one to three cytotoxic chemotherapy regimes (including a platin-based protocol)
• ECOG performance status 0-2
• Life expectancy = 3 months
• Age = 18 years
• Adequate bone marrow reserve (neutrophils = 1500/mm³ and platelets > 100.000/mm³)
• Effective contraception in pre-menopausal female and male patients
• Patient´s written informed consent
• Ability to comply with the protocol procedures
• Mitotane intake should be stopped one months before the study entry

• Diagnosi istologica di carcinona cortico-surrenale (ACC)
• Malattia localmente avanzata o metastatica non suscettibile di resezione chirurgica radicale
• Malattia radiologicamente monitorabile
• Progressione di malattia dopo regimi chemioterapici citotossici contenenti un derivato del platino
• Performance Status ECOG: compreso tra 0-2
• Aspettativa di vita = 3 mesi
• Età = 18 anni
• Adeguata funzionalità epatica e renale
• Adeguata funzionalità midollare (neutrofili = 1500/mm³ e piastrine > 100.000/mm³)
• Impegno a non intraprendere/non far intraprendere una gravidanza nel periodo indicato dallo sperimentatore
• Consenso informato scritto
• Possibilità di una adeguata aderenza alle procedure di protocollo

E.4

Principal exclusion criteria

• History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
• Serum creatinine > 1.5 x ULN, BCC <60 mL/min) or hepatic insufficiency (ALT / AST > 1.5 x ULN or ALT/AST >5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN) Hemoglobin <10.0 g/dL;
• Total bilirubin >1x ULN,
• Creatinine < 1.5 ULN;
• Decompensated heart failure (ejection fraction <45%), myocardial infarction or revascularization procedure during the last 6 months, unstable angina pectoris, uncontrolled cardiac arrhythmia
• Pregnancy or breast feeding
• Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
• Patients with serum levels of mitotane (evaluated one week before the study start) in the therapeutic range (14-20 mcg/ml).History of severe hypersensitivity reaction (=grade 3) to docetaxel
• History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs
• Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Annex 1 and Annex 2)
• Concomitant vaccination with yellow fever vaccine

• Pregressa neoplasia maligna, ad eccezione del tumore della pelle non-melanoma e carcinoma in situ della cervice uterina curati efficacemente, o altra neoplasia maligna trattata con assenza di recidiva di malattia per almeno tre anni.
• Creatinina sierica > 1.5 x ULN (upper limit of normality = limite massimo del range di normalità), BCC <60 mL/min) o insufficienza epatica (ALT / AST > 2.5 x ULN o ALT/AST >5 x ULN se le alterazioni della funzionalità epatica sono causate dalla malattia maligna sottostante e/o bilirubina sierica totale > 2.5 x ULN)
• Insufficienza cardiaca scompensata (frazione di eiezione <45%), infarto miocardico o rivascolarizzazione nel corso degli ultimi 6 mesi, angina pectoris instabile, aritmia cardiaca non controllata
• Gravidanza o allattamento
• Ogni altra condizione severa acuta o cronica medica o psichiatrica, o anomalia dei valori di laboratorio che potrebbero, a giudizio dello sperimentatore, incrementare il rischio di morte o gravi effetti collaterali associati alla somministrazione del farmaco in studio, o che potrebbero rendere inappropriato l’inserimento del paziente nello studio
• Pazienti con livelli sierici di mitotane (valutati una settimana prima dell’inizio dello studio) all’interno del range terapeutico (14-20 mcg/ml).

E.5 End points

E.5.1

Primary end point(s)

To assess the clinical benefit as measured by a non progressing rate after 4 months of the cabazitaxel in patients with locally advanced or metastatic ACC who progressed after cytotoxic therapy.

Determinare l’attività di cabazitaxel nei pazienti affetti da carcinoma della corticale del surrene metastatico in progressione dopo precedente chemioterapia citotossica contenente cisplatino.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day1
Cycle 2 until disease progression
(max 6 cycles) Discontinues from treatment
28 days after last dose)
Every 30 days for 6 months

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Every 8 weeks for the first 4 months and every 12 weeks

La valutazione della risposta verrà effettuata ogni 8 settimane per i primi 4 mesi e ogni 12 settimane

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

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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)

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)

E.8.2.2

Placebo

E.8.2.3

Other

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

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.1.1.1

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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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 continue to be treated in accordance with current guidelines

i pazienti continueranno ad essere trattati in conformità alle linee guida vigenti

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

2017-12-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-09

P. End of Trial
P.	End of Trial Status	Completed

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