Clinical Trials Register

Summary
EudraCT Number:	2012-000996-17
Sponsor's Protocol Code Number:	201200099617
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:	2012-08-06
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

2012-000996-17

A.3

Full title of the trial

Phase II study of biweekly cabazitaxel in patients affected by castration resistant prostate cancer previously treated with docetaxel: evaluation of safety and quality of life.

A.3.1

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

Phase II study of biweekly cabazitaxel in patients affected by castration resistant prostate cancer previously treated with docetaxel: evaluation of safety and quality of life.

A.3.2

Name or abbreviated title of the trial where available

CABA-15

A.4.1

Sponsor's protocol code number

201200099617

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 UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
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	UNIVERSITA LA SAPIENZA - POLICLINICO UMBERTO I
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	DIP. DI SCIENZE RADIOLOGICHE, ONCOLOGICHE ED ANATOMO PATOLOGICHE - UNIVERSITA' LA SAPIENZA - AZ. POLICLINICO UMBERTO I
B.5.2	Functional name of contact point	ONCOLOGIA B
B.5.3	Address:
B.5.3.1	Street Address	VIALE REGINA ELENA, 324
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00161
B.5.3.4	Country	Italy
B.5.4	Telephone number	06/49970408
B.5.5	Fax number	06/4463686
B.5.6	E-mail	dhoncologico.cortesi@uniroma1.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*EV 1FL 60MG 1,5ML+1FL
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS SpA
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.3.4	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	CABAZITAXEL
D.3.9.1	CAS number	183133-96-2
D.3.9.4	EV Substance Code	SUB31282
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	Yes
D.3.11.13.1	Other medicinal product type	chemioterapico

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

Subjects affected by metastatic castration refractory prostate cancer progressed or intolerant to a previous docetaxel-based chemotherapy.

Soggetti adulti affetti da carcinoma prostatico metastatico resistente alla castrazione e che abbiano ricevuto o siano intolleranti ad una precedente terapia a base di taxani.

E.1.1.1

Medical condition in easily understood language

Subjects affected by metastatic castration refractory prostate cancer progressed or intolerant to a previous docetaxel-based chemotherapy.

Soggetti adulti affetti da carcinoma prostatico metastatico resistente alla castrazione e che abbiano ricevuto o siano intolleranti ad una precedente terapia a base di taxani

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

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 incidence of grade 3 or 4 neutropenia in phase III trial was 83%, in this study patients were treated with cabazitaxel 25 mg/mq every three weeks. We hypothesized that treatment with cabazitaxel at dosage of 15 mg/mq every two weeks may reduce the incidence of grade 3 or 4 neutropenia from 83% to 50%.

L'incidenza di neutropenia di grado 3 o 4 nello studio di fase III è stata dell'83%. Lo scopo di questo studio è ridurre l'incidenza di neutropenia di grado 3 o 4 dall'83% al 50% tramite una diversa schedula di somministrazione.

E.2.2

Secondary objectives of the trial

- Safety and tolerability - Progression-Free Survival (PFS) - Overall survival (OS) - PSA response rate (PSA-RR) - Explore circulating tumor cells (CTC) in whole blood and their associations with efficacy endpoints - Evaluation of patient-reported outcomes (PRO), including pain intensity (BPI-sf worst pain), and health state utilities (EQ-5D) will be examined.

- Sicurezza e tollerabilità:- Intervallo libero da progressione:- Sopravvivenza globale;- Tasso di risposta del PSA;- Analisi esplorativa dell'andamento delle cellule tumorali circolanti.- Valutazione della qualità di vita dei pazienti e della riduzione del dolore.

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

LIFE QUALITY:
Vers:1
Date:2012/01/10
Title:Evaluation of patient-reported utcomes (PRO), including pain intensity (BPI-sf worst pain), and health state utilities (EQ-5D) will be examined.
Objectives:To describe the quality of life and the pain control in patients treated with cabaziatxel.

QUALITA DELLA VITA:
Vers:1
Data:2012/01/10
Titolo:Valutazione della qualità di vita e del controllo del dolore nei pazientie trattati con cabazitaxel.
Obiettivi:Descrivere la variazione della qualità di vita e del dolore nei pazienti trattati con cabazitaxel.

E.3

Principal inclusion criteria

1. Diagnosis of histologically or cytologically proven prostate adenocarcinoma that is resistant to hormone therapy and previously treated with a docetaxel-containing regimen. 2. Age ≥18 years old. 3. Patient must have either radiologically measurable or non-measurable disease. 4. Received prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents. 5. Life expectancy > 6 months. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (ie, patient must be ambulatory, capable of all self-care, and up and about more than 50% of waking hours). 7. Written informed consent.

1. Diagnosi istologica o citologica di adenocarcinoma della prostata resistente alla castrazione e precedentemente trattata con docetaxel. 2. Età maggiore di 18 anni. 3. Presenza di malattia radiologicamente misurabile o non misurabile. 4. Aver ricevuto una castrazione chirurgica o un trattamento medico a base di ormone stimolante il rilascio dell'ormone luteinizzante con o senza trattamento antiandrogenico, sopensione del trattamento antiandrogenico, trattamento con estramustina o altri trattamenti ormonali. 5. Aspettativa di vita superiore a sei mesi. 6. Eastern Cooperative Oncology Group (ECOG)Performance Status 0-2. 7. Firma del consenso informato.

E.4

Principal exclusion criteria

1. Previous treatment with cabazitaxel. 2. Prior isotope therapy or radiotherapy to ≥ 30% of bone marrow. In case of prior isotope therapy 12 weeks must have elapsed prior to first study drug administration. 3. Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade > 1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization. 4. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study. 5. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed ≥ 5 years ago and from which the patient has been disease-free for ≥ 5 years. 6. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization. 7. Known brain or leptomeningeal involvement. 8. Other concurrent serious illness or medical conditions. 9. Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure or myocardial infarction within last 6 months is also not allowed. 10. Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or to comply with the study procedures or interfere with interpretation of study results. 11. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study. 12. Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period. The definition of ''effective method of contraception'' will be based on the Investigator's judgment. Patients' Partners of childbearing potential (unless surgically sterile, post menopausal or for another reason have no chance of becoming pregnant) not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and /or in a local protocol addendum. 13. Inadequate organ and bone marrow function. 14. Contraindications to the use of corticosteroid treatment. 15. Symptomatic peripheral neuropathy grade > 2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.4.03).

1. Precedente trattamento con cabazitaxel. 2. Precedente radioterapia con isotopi o radioterapia in più del 30% del midollo osseo. 3. Eventi avversi (esclusa l'alopecia) di grado > 1 derivanti da ogni precedente trattamento. 4. Precedente trattamento chirurgico, radioterapico o chemioterapico nelle 4 settimane precedenti l'arruolamento nello studio. 5. Precedenti neoplasie. 6. Partecipazione in un altro studio clinico contemporaneamente a questo. 7. Presenza di metastasi cerebrali o meningee. 8. Diagnosi concomitante di altre condizioni morbose definite gravi. 9. Diagnosi di aritmie cardiache, angina pectoris e/o ipertensione incontrollate. Storia di insufficienza cardiaca congestizia o onfato del miocardio nei precednti sei mesi. 10. Assenza di consenso informato. 11. Pazienti con capacità riproduttive che non acconsentono ad evitare una gravidanza per tutta la durata del trattamento e dopo sei mesi dal termine dello stesso. 12. Inadeguta funzione d'organo o midollare. 13. Controindicazione all'utilizzo di corticosteroidi. 15.Neuropatia periferica sintomatica di grado > 2.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years.

2 anni.

E.5.2

Secondary end point(s)

- Sicurezza e tollerabilità: - Intervallo libero da progressione: - Sopravvivenza globale; - Tasso di risposta del PSA; - Analisi esplorativa dell'andamento delle cellule tumorali circolanti. - Valutazione della qualità di vita dei pazienti e della riduzione del dolore.

E.5.2.1

Timepoint(s) of evaluation of this end point

3 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

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

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

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

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.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 be contacted periodically to assess if they are alive or not

I pazienti verranno contattitti periodicamente per accertare lo stato in vita.

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

2012-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-14

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

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