Clinical Trials Register

Summary
EudraCT Number:	2011-005730-20
Sponsor's Protocol Code Number:	G.04.2011
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:	2011-12-16
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

2011-005730-20

A.3

Full title of the trial

Maintenance treatment with Lanreotide in Patients with small cell lung cancer (LD/ED) expressing SST receptors, responsive to a first line standard chemotherapy/radiotherapy

Terapia di mantenimento con Lanreotide in pazienti con microcitoma polmonare (LD/ED) esprimenti i recettori SST in risposta dopo una prima linea di trattamento (CT/RT) standard

A.3.1

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

Maintenance treatment with Lanreotide in Patients with small cell lung cancer expressing SST receptors, responsive to a first line standard chemotherapy/radiotherapy

Terapia di mantenimento con Lanreotide in pazienti con microcitoma polmonare esprimenti i recettori SST in risposta dopo una prima linea di trattamento standard

A.4.1

Sponsor's protocol code number

G.04.2011

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	A.O. UNIVERSITARIA INTEGRATA DI VERONA
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	IPSEN 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	INFORMA S.r.l.
B.5.2	Functional name of contact point	cro
B.5.3	Address:
B.5.3.1	Street Address	via del Commercio, 36
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00154
B.5.3.4	Country	Italy
B.5.4	Telephone number	065758926
B.5.5	Fax number	065759937
B.5.6	E-mail	v.granelli@informacro.info

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	IPSTYL*SC SIR 120MG
D.2.1.1.2	Name of the Marketing Authorisation holder	IPSEN 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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LANREOTIDE ACETATE
D.3.9.1	CAS number	127984-74-1
D.3.9.4	EV Substance Code	SUB14326MIG
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	120
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

Small cell lung cancer

Carcinoma polmonare a piccole cellule

E.1.1.1

Medical condition in easily understood language

Small cell lung cancer

Tumore del polmone a piccole cellule

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	10029882
E.1.2	Term	Oat cell carcinoma
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 determine the effectiveness, in terms of improved time to disease progression (or progression-free survival, PFS) at 1 year, of maintenance therapy with 120 mg Lanreotide (injection) vs control, in patients affected by SCLC (LD/ED),in patients with SCLC (LD / ED), Octreoscan positive, and who have obtained a response (partial or complete) after a I line standard therapy. PFS is defined as the time from study enrolment to first observation of local or metastatic disease progression or death (or both) for any reason.

Stabilire l’efficacia, in termini di miglioramento del tempo alla progressione di malattia (o progression-free survival, PFS) a 1 anno, della terapia di mantenimento con Lanreotide 120 mg (soluzione iniettabile) vs controllo in pazienti affetti da SCLC (LD/ED), Octreoscan positivi, e che abbiano ottenuto una risposta (parziale o completa) dopo una terapia standard di I linea. La PFS viene definita come l’intervallo di tempo tra l’arruolamento in studio e la comparsa di documentata progressione di malattia (locale o metastasi a distanza) oppure morte del paziente (o entrambe) per qualsiasi causa.

E.2.2

Secondary objectives of the trial

- To establish the safety of treatment with Lanreotide after standard Chemo/radiotherapy in patients with SCLC. - To establish the Overall Survival (OS) at 2 years, defined as as the% of patients alive at 2 years of diagnosis of SCLC.

- stabilire la sicurezza del trattamento con Lanreotide dopo un trattamento chemio/radioterapico standard nei pazienti affetti da SCLC. - stabilire la sopravvivenza globale (OS) a 2 anni, definita come la % di pazienti vivi a 2 anni dalla diagnosi di SCLC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Age > 18 and < 75 2.Histological or cytological proven diagnosis of small-cell lung cancer (SCLC) LD and ED 3.Complete response or partial response after a first line standard chemotherapy/radiotherapy completed no more than 45 days before enrollment 4.SST receptors expression (as detected by Octreoscan uptake at diagnosis) 5.Performance Status (ECOG) 0-2 6.Life expectancy greater than 3 months 7.Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 14 days prior to the start of the study treatment (leucocyte count >3.000/μl, neutrophils >1.500/μl, platelet count >100.000/μl, total bilirubin <1.5 times the upper limit of normal (ULN), AST(SGOT) and ALT(SGPT) <2.5xULN, serum creatinine <1.25xULN (or >1.25xULN and <1.5xULN with creatinine clearance >60ml/min) 8.Negative pregnancy test (only for fertile women who must use effective contraception) 9.Patients must be accessible for treatment and follow up. 10.Patients must be able to understand and sign written informed consent.

1.età > 18 e < 75 anni 2.diagnosi citologica o istologica comprovata di SCLC sia LD (tumore entro la cavità toracica, T1-4, N1-3, M0) che ED (tumore esteso M1ab) 3.RC o RP dopo chemioterapia / Radioterapia standard di I linea ultimata da non più di 45 giorni. 4.positività dei recettori SST (rilevata alla scintigrafia con Octreoscan alla diagnosi) 5.Performance Status (ECOG) 0-2 6.aspettativa di vita > 3 mesi 7.adeguata funzione epatica, renale e riserva midollare documentate agli esami di laboratorio eseguiti entro 14 giorni dall’inizio del trattamento sperimentale (leucociti > 3.000 µl, neutrofili ≥ 1.500 µl, piastrine≥100.000 µl, bilirubina totale < 1.5 volte il limite normale, AST(sGOT) e ALT(sGPT) < 2.5 volte il limite normale, creatinina serica < 1.25 volte il limite normale (o > 1.25 volte, ma < 1.5 volte il limite normale con creatinina clearance > 60 ml/min) 8.test di gravidanza negativo (solo per le donne in età fertile, che dovranno seguire adeguate misure contraccettive) 9.accessibilità al trattamento e al follow-up 10.paziente capace di comprendere ed esprimere il proprio consenso informato scritto allo studio clinico.

E.4

Principal exclusion criteria

1.Stable disease (SD) or progression (PD) after a first-line standard treatment (CT / RT) 2.Time > 45 days after the first line standard therapy 3.Clinically significant cardiovascular disease e.g. cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication 4.Intercurrent and not controlled acute infectious disease 5.Psychological or social conditions which might affect study compliance 6.Severe Parkinson disease 7.Unstable neurologic function 8.Known history of atrophic gastritis 9.Known history of cholelithiasis 10.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized cancers (eg. Non melanoma skin cancer, cervical ) effectively treated 11. Patients with known allergy to any of the components of the study medication 12.Pregnancy or lactation 13.Treatment with any investigational drug within 30 days prior to enrolment 14.Prior treatment with somatostatin analoques.

1.malattia stabile (SD) o in progressione (PD) dopo una prima linea di trattamento (CT/RT) standard 2.tempo intercorso dopo I linea standard > di 45 giorni 3.malattie cardiovascolari clinicamente significative: accidenti cerebrovascolari < 6 mesi, infarto miocardico < 6 mesi, angina instabile, cardiopatia congestizia di grado > II secondo i criteri NYHA, aritmie cardiache serie che necessitano di trattamento farmacologico 4.infezioni acute intercorrenti non controllate 5.condizioni psicologiche o sociali tali da compromettere l’adesione al trattamento 6.malattia di Parkinson di grado severo 7.funzioni neurologiche instabili 8.nota storia di gastrite atrofica 9.nota storia di colelitiasi 10.coesistenza di altre neoplasie o neoplasie diagnosticate ≤ 5 anni precedenti l’inizio dello studio, ad eccezione di neoplasie localizzate (es della cute non melanoma, tumore della cervice uterina) efficacemente trattate. 11.pazienti con nota allergia a qualsiasi composto presente nel trattamento farmacologico richiesto dallo studio 12.gravidanza e allattamento 13.trattamento con farmaci sperimentali < 30 giorni dall’arruolamento nello studio 14.precedente terapia con analoghi della somatostatina.

E.5 End points

E.5.1

Primary end point(s)

PFS progression-free survival at 1 year of maintenance therapy

PFS a 1 anno dall'inizio terapia di mantenimento

E.5.1.1

Timepoint(s) of evaluation of this end point

1 year

1 anno

E.5.2

Secondary end point(s)

- Overall Survival (OS) at 2 years, - Criteria CTCs (as defined on NCI) to evaluate tossicity

- OS a 2 anni - criteri CTCs (secondo NCI)per valutare la tossicità

E.5.2.1

Timepoint(s) of evaluation of this end point

2 years

2 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)

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

Osservazione

Observation

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

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:

100

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

134

F.4.2

For a multinational trial

F.4.2.1

In the EEA

134

F.4.2.2

In the whole clinical trial

134

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)

In each site follow up programs will be in accordance with the normal clinical pratice

In ogni centro i programmi di follow-up avverranno in accordo alla normale partica clinica

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

2011-12-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-14

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

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