Clinical Trials Register

Summary
EudraCT Number:	2011-006246-33
Sponsor's Protocol Code Number:	LTS12674
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:	2012-12-19
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

2011-006246-33

A.3

Full title of the trial

International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental Study

Studio di estensione del trattamento in aperto, multicentrico, internazionale con Iniparib in monoterapia o in associazione a regimi chemioterapici in pazienti affetti da tumore che hanno ottenuto un beneficio clinico da Iniparib in seguito al completamento di uno studio originario di fase 1, 2 o 3.

A.3.1

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

Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited from Iniparib in a Clinical Trial

studio di estensione del trattmento per pazienti che hanno precedentemente partecipato ed hanno tratto beneficio dal trattamento con Iniparib in uno studio clinico

A.4.1

Sponsor's protocol code number

LTS12674

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	SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT
B.1.3.4	Country	France
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	Sanofi-aventis recherche et de'veloppement
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	sanofi-aventis SpA
B.5.2	Functional name of contact point	Contact point
B.5.3	Address:
B.5.3.1	Street Address	Vle Bodio 37b
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20158
B.5.3.4	Country	Italy
B.5.4	Telephone number	800.226343
B.5.5	Fax number	02.3939.4168
B.5.6	E-mail	informazioni.medicoscientifiche@sanofi-aventis.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	Iniparib
D.3.2	Product code	SAR240550
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	160003-66-7
D.3.9.2	Current sponsor code	SAR240550
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	20
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.IMP: 2
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	carboplatino
D.3.2	Product code	NA
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carboplatino
D.3.9.1	CAS number	41575-94-4
D.3.9.2	Current sponsor code	SUB06614MIG
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	10
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.IMP: 3
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	GEMCITABINA TEVA IT*10FL 1G
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA ITALIA Srl
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	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	GEMCITABINE HYDROCHLORIDE
D.3.9.1	CAS number	122111-03-9
D.3.9.4	EV Substance Code	SUB02324MIG
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	1000
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

Solid Tumors

Tumori solidi

E.1.1.1

Medical condition in easily understood language

Tumori solidi

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	PT
E.1.2	Classification code	10028997
E.1.2	Term	Neoplasm malignant
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

The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study’s objectives

Valutare la sicurezza e la tollerabilità di iniparib somministrato in monoterapia o in regimi di associazione in pazienti trattati con iniparib in un precedente studio clinico che hanno ottenuto un beneficio clinico in seguito al completamento degli obiettivi dello studio originario.

E.2.2

Secondary objectives of the trial

not applicabile

non applicabile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen. - Previously received and are continuing to derive clinical benefit from iniparib, as monotherapy or in combination with chemotherapy, as determined by the treating physician. - Ongoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol. - On a stable parental study regimen (at least one cycle fo the regimen at the dose/schedule that isto be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). - Signed written informed consent.

I 01. Pazienti affetti da tumore di almeno 18 anni di età che hanno completato tutte le valutazioni necessarie per soddisfare gli obiettivi primari di uno studio clinico originario di fase 1, 2 o 3 su iniparib in monoterapia o in regime di associazione. I 02. Pazienti precedentemente trattati con iniparib che continuano a trarre un beneficio clinico da iniparib, in monoterapia o in associazione a chemioterapia, in base a quanto stabilito dal medico sperimentatore. I 03. Pazienti in trattamento con iniparib al momento del completamento o della conclusione dello studio originario che soddisfano i criteri per iniziare un successivo ciclo di terapia, come descritto nel protocollo dello studio originario. I 04. Pazienti in regime stabile rispetto allo studio originario (almeno un ciclo del regime terapeutico alla dose/dosaggio che si intende somministrare nello studio di estensione della terapia deve essere stato somministrato al paziente prima che questo concludesse la sua partecipazione allo studio originario). I 05. Consenso informato scritto firmato

E.4

Principal exclusion criteria

Patient has not previously participated in any clinical trial of iniparib. - Patient has evidence of progressive disease while receiving iniparib. - Patient has another concurrent invasive malignancy (aside from the malignancy for which the patient has received therapy for on the parental protocol). - Patient has a major medical or co-morbid condition(s) that the investigator believes might compromise safe participation in the study (such as uncontrolled lung, kidney, or liver problems; uncontrolled infection; a history of congestive heart failure; or an electrocardiogram suggesting significant problems with the heart). - Patient has not recovered to baseline or less than Grade 1 from non-hematologic adverse events related to any anticancer therapy received prior to signing informed consent on the Treatment Extension study, with the exception of hair loss. - Patient is receiving concurrent treatment with other investigational agents not allowed as part of the combination regimen in the parental study protocol. - Concurrent anticancer treatment with any agent other than iniparib and any co-administered chemotherapeutic agent(s) specificied on the parental study protocol are not permitted throughout the course of the study. - Patient is receiving concurrent radiation therapy to treat primary disease with curative intent. (Note that palliative radiotherapy is allowed as long as there is no evidence of progressive disease.) - Patient is unable to comply with the requirements of the study. - Pregnant or breast-feeding women. - Women of childbearing potential or men with partners of childbearing potential who are not protected or who are unwilling to use an effective contraceptive method of birth control during the course of the study and for a period of 6 months following the last dose.

E 01. Pazienti che non abbiano partecipato a precedenti studi clinici su iniparib. E 02. Pazienti che presentino una progressione della malattia durante il trattamento con iniparib. E 03. Pazienti affetti da un altro tumore maligno invasivo concomitante (ad eccezione del tumore maligno per cui il paziente ha ricevuto il trattamento nel protocollo originario). E 04. Pazienti che presentino patologie gravi o condizioni di comorbidità che, in base all’opinione dello sperimentatore, possono compromettere la sicurezza della partecipazione allo studio (ossia disfunzione epatica, renale o polmonare non controllata, infezione non controllata, anamnesi di insufficienza cardiaca congestizia o un ECG che suggerisce la presenza di un difetto di conduzione significativo o di ischemia miocardica). E 05. Pazienti che non si siano ristabiliti da AE non ematologici rispetto al basale o di grado ≤ 1 (secondo i criteri NCI-CTCAE, versione 4.03) correlati alla terapia antitumorale ricevuta prima della firma del consenso informato relativo allo studio di estensione del trattamento, ad eccezione dell’alopecia. E 06. Pazienti attualmente in trattamento con altri agenti sperimentali non consentiti come parte del regime di associazione nel protocollo dello studio originario. E 07. Nel corso dello studio, non è consentita alcuna terapia antitumorale concomitante con farmaci sperimentali diversi da iniparib e dagli agenti chemioterapici somministrati congiuntamente a iniparib come specificato nel protocollo dello studio originario. E 08. Pazienti che stanno seguendo un trattamento radioterapico concomitante per trattare la malattia di base con intento curativo (si noti che la radioterapia palliativa è consentita finché non vi sia evidenza di progressione della malattia). E 09. Pazienti che non siano in grado di rispettare i requisiti dello studio. E 10. Donne in stato di gravidanza o che allattano al seno. E 11. Donne in età fertile o uomini con partner in età fertile che hanno rapporti non protetti o che non intendono utilizzare un metodo contraccettivo efficace nel corso dello studio e per un periodo di 6 mesi dalla somministrazione dell’ultima dose.

E.5 End points

E.5.1

Primary end point(s)

Number of participants with incidence of adverse events by NCI-CTCAE version 4.03

L’endpoint primario di questo studio è la valutazione della sicurezza e della tollerabilità di iniparib. La sicurezza sarà valutata in base all’incidenza e alla frequenza degli eventi avversi /criteri NCI-CTCAE (versione 4.03).

E.5.1.1

Timepoint(s) of evaluation of this end point

During treatment and up to 30 days after last treatment dose

durante il trattamento e fino a 30 giorni dopo l'ultima somministrazione

E.5.2

Secondary end point(s)

not applicable

non applicabile

E.5.2.1

Timepoint(s) of evaluation of this end point

not applicable

non applicabile

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

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

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)

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

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

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

LPLV

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

204

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

300

F.4.2.2

In the whole clinical trial

300

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)

decison of the Investigator.

a decisione del medico Sperimentatore

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

2013-01-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-09-26

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