Clinical Trials Register

Summary
EudraCT Number:	2005-000051-15
Sponsor's Protocol Code Number:	A4061008
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:	2012-08-07
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

2005-000051-15

A.3

Full title of the trial

CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2,
AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN
CLINICAL TRIALS

ACCESSO CONTINUO ALL'INIBITORE DELLA TIROSIN-CHINASI DI VEGFR-2, AG-013736 (A406), PER PAZIENTI PRECEDENTEMENTE TRATTATI CON AG-013736 IN SPERIMENTAZIONI CLINICHE

A.3.1

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

CONTINUING ACCESS TO THE TYROSINE KINASE INHIBITOR OF VEGFR-2,
AG-013736 (A406) FOR PATIENTS PREVIOUSLY RECEIVING AG-013736 IN
CLINICAL TRIALS

ACCESSO CONTINUO ALL’INIBITORE DELLA TIROSIN-CHINASI DI VEGFR-2, AG-013736 (A406), PER PAZIENTI PRECEDENTEMENTE TRATTATI CON AG-013736 IN SPERIMENTAZIONI CLINICHE

A.4.1

Sponsor's protocol code number

A4061008

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00828919

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	PFIZER INC.
B.1.3.4	Country	United States
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	Pfizer Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pfizer Inc
B.5.2	Functional name of contact point	ClinicalTrials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	001 800 7181021
B.5.5	Fax number	001 303 7391119
B.5.6	E-mail	ClinicalTrials.govCallCenter@pfizer.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	Axitinib
D.3.2	Product code	AG-013736
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AXITINIB
D.3.9.1	CAS number	319460-85-0
D.3.9.2	Current sponsor code	AG-013736
D.3.9.3	Other descriptive name	IUPAC N-methyl-2-3((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl-benzamide
D.3.9.4	EV Substance Code	SUB25427
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	1
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	Axitinib
D.3.2	Product code	AG-013736
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AXITINIB
D.3.9.1	CAS number	319460-85-0
D.3.9.2	Current sponsor code	AG-013736
D.3.9.3	Other descriptive name	IUPAC N-methyl-2-3((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl-benzamide
D.3.9.4	EV Substance Code	SUB25427
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	5
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

Patients who have been treated in previous AG-013736 oncology studies.

Pazienti già trattati con AG-013736 in precedenti sperimentazioni cliniche oncologiche

E.1.1.1

Medical condition in easily understood language

Various solid tumor types

Vari tipi di tumore solido

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	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.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10029104
E.1.2	Term	Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 objective of the trial is to provide continued access to AG-013736 tablets to patients who were assigned to an AG-013736-containing treatment arm in a previous AG-013736 trial and who had documented stable or responding disease at the time they discontinued in the trial. Continuing access will be provided to patients who have Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study.

L’obiettivo della sperimentazione è di fornire un trattamento con AG-013736 in compresse a pazienti randomizzati in un braccio di trattamento contenente AG-013736 in un precedente studio clinico con la molecola con malattia stabile documentata o responsiva nel momento in cui hanno interrotto la sperimentazione. Il trattamento continuo sarà fornito a pazienti con malattia in progressione (PD), ma che hanno ricevuto un beneficio clinico dal precedente trattamento con AG-013736. In tal caso, si definisce beneficio clinico la somma dei diametri più lunghi (SLD) delle lesioni misurabili residue che sono rimaste inferiori o pari alla SLD basale nella precedente sperimentazione con AG-013736. Tali pazienti non devono essere eleggibili ad un trattamento con altre terapie approvate e disponibili per la patologia in studio.

E.2.2

Secondary objectives of the trial

Not applicable

non applicabile

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:  Patients who were assigned to an AG-013736-containing treatment arm in a previous clinical trial.  Patients who were receiving AG-013736 tablets at the time their previous trial ended.  Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous AG-013736 protocol should be used to determine stable or responding disease).  Patients who have Progressive Disease (PD) but have experienced clinical benefit from previous AG-013736 treatment will be eligible for enrollment; in this case, clinical benefit is defined as the Sum of Longest Diameters (SLD) of measurable lesions remaining less than or equal to the baseline SLD in the previous AG-013736 trial. These patients must not be eligible for treatment with other available approved therapy for the disease under study. The Pfizer clinician must approve the enrollment prior to treatment start.  Patients who are informed of, and willing and able to comply with the investigational nature of the trial, and have signed a written informed consent in accordance with institutional and ICH GCP guidelines.

I soggetti devono soddisfare tutti i seguenti criteri di inclusione per essere considerati eleggibili all’arruolamento nello studio: • Pazienti stati randomizzati ad un braccio di trattamento contenente AG-013736 in una precedente sperimentazione clinica. • Pazienti trattati con AG-013736 in compresse al momento della conclusione della loro precedente sperimentazione clinica. • Pazienti in malattia stabile (SD) o responsiva (PR o CR) documentata da opportuni esami radiologici, clinici e di laboratorio entro 12 settimane prima dell’arruolamento (Nota: Per determinare se la patologia sia stabile o responsiva, devono essere utilizzati i criteri di risposta del precedente protocollo con AG-013736). • I pazienti in progressione di malattia (PD), ma che hanno ricevuto un beneficio clinico dal precedente trattamento con AG-013736 ; in tal caso, si definisce beneficio clinico la somma dei diametri più lunghi (SLD) di lesioni misurabili residue inferiori o pari alla SLD basale nella precedente sperimentazione con AG-013736. Tali pazienti devono risultare non eleggibili ad un trattamento con altre terapie disponibili approvate per la patologia in studio. Il clinico di Pfizer deve approvare l’arruolamento prima dell’inizio del trattamento. • Pazienti disposti a rispettare l’aspetto sperimentale dello studio, in grado di farlo, ne siano stati informati ed abbiano firmato un consenso informato scritto in conformità alle linee guida istituzionali e delle ICH –GCP.

E.4

Principal exclusion criteria

Subjects presenting with any of the following will not be included in the trial:  Patients may not participate in this trial if the conditions for continuing treatment in the previous AG-013736 protocol are not met.

I pazienti che presentano qualsiasi dei seguenti aspetti non saranno inclusi nello studio: • Pazienti che non abbiano le condizioni per continuare il trattamento del precedente protocollo con AG-013736.

E.5 End points

E.5.1

Primary end point(s)

All patients will be assessed for safety by monitoring adverse events and laboratory values per
standard clinical practice. Response to therapy will not be evaluated.

In tutti i pazienti verrà valutato il profilo di sicurezza monitorando gli eventi avversi ed i parametri di laboratorio secondo la pratica clinica standard. Non sarà valutata la risposta alla terapia.

E.5.1.1

Timepoint(s) of evaluation of this end point

All patients will be assessed for safety by monitoring adverse events and laboratory values per
standard clinical practice. Response to therapy will not be evaluated.

E.5.2

Secondary end point(s)

n/a

E.5.2.1

Timepoint(s) of evaluation of this end point

n/a

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

Yes

E.6.13.1

Other scope of the trial description

Continuation study for patients previously receiving AG-013736 in clinical trials

studio di estensione per pazienti precedentemente trattati con AG-013736 in studi clinici

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)

Yes

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

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

United States

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

End of trial in all participating countries is defined as the time at which all patients enrolled in the study have completed treatment on study.

La fine delle sperimentazione in tutti i paesi partecipanti è definito come il momento in cui tutti i pazienti arruolati nello studio hanno completato il trattamento di studio

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:

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

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)

not applicable

non applicabile

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

2012-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-24

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

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