Clinical Trials Register

Summary
EudraCT Number:	2017-002960-42
Sponsor's Protocol Code Number:	Yttrium-90-02
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:	2021-09-07
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

2017-002960-42

A.3

Full title of the trial

173/5000
Forse cercavi: Terapia radiometabolica recettoriale-mediata con [90Y-DOTA0-Tyr3]-octreotide (90Y-DOTATOC) nei tumori endocrini del tratto gastroenteropancreatico e bronchiale. (Yttrium-90-02)

Receptor-mediated radiometabolic therapy with [90Y-DOTA0-Tyr3] -octreotide (90Y-DOTATOC) in endocrine gastroenteropancreatic and bronchial tumors. (Yttrium-90-02)

Terapia radiometabolica recettore-mediata con [90Y-DOTA0-Tyr3]-octreotide (90Y-DOTATOC) nei tumori endocrini del tratto gastroenteropancreatico e bronchiale. (Yttrium-90-02)

A.3.1

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

Radiometabolic therapy in endocrine gastroenteropancreatic and bronchial tumors.

Terapia radiometabolica nei tumori endocrini del tratto gastroenteropancreatico e bronchiale.

A.3.2

Name or abbreviated title of the trial where available

Radiometabolic therapy in endocrin cancer

Terapia radiometabolica nei tumori endocrini

A.4.1

Sponsor's protocol code number

Yttrium-90-02

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 UNITÀ SANITARIA LOCALE DELLA ROMAGNA
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	AUSL DELLA ROMAGNA
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	AUSL DELLA ROMAGNA
B.5.2	Functional name of contact point	UFFICIO RICERCA
B.5.3	Address:
B.5.3.1	Street Address	VIA CORIANO 38
B.5.3.2	Town/ city	RIMINI
B.5.3.3	Post code	47921
B.5.3.4	Country	Italy
B.5.4	Telephone number	0541/707813
B.5.5	Fax number	0541/707813
B.5.6	E-mail	ilaria.panzini@uslromagna.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	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	[90Y-DOTA0-Tyr3]-octreotide (90Y-DOTATOC)
D.3.2	Product code	[(90Y-DOTATOC)]
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	No
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	Yes
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 with Somatostatin receptors Neoplasms

Pazienti con neoplasie esprimenti recettori della somatostatina

E.1.1.1

Medical condition in easily understood language

Patients with Somatostatin receptors Neoplasms

Pazienti con neoplasie esprimenti recettori della somatostatina

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	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10014713
E.1.2	Term	Endocrine neoplasms malignant and unspecified
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

Disease control

Controllo di malattia

E.2.2

Secondary objectives of the trial

PFS, OS, Adverse events

PFS, OS, Tossicità

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Will be enrolled for treating patients:
• of both sexes;
• age = 18 years and = 85 years;
• histologic and immuno-histochemical diagnosis of endocrine tumor with limitation to gastroenteropancreatic and bronchial districts;
• grading (evaluated on the basis of the cell proliferation index with Ki-67 (Mib1): 1 and 2 and 3 (non-differentiated forms with ki67> 55%);
For bronchial NETs, ¿¿typical and atypical carcinoids will be enrolled without any limitations of positive k67 positive for sstr2 receptors.
• documented high expression of somatostatin receptors documented by PET-TC with 68Ga-DOTATOC
• for which standard treatments which are already documented and of equal effectiveness are not proposed;
• with stored hematologic, hepatic and renal parameters, in particular: GB = 2.5 10 ^ 9 / L, Hb = 10 g / dL, PTL = 100,000 10 ^ 9 / L, Total Bilirubin = 2.5 mg / dL, Creatinine = 2.0 md / dl;
• with parametrizable disease according to the RECIST 1.1 criteria by conventional imaging (TC or RMN) not earlier than three months compared with the enrollment;
• who have not received chemotherapy and / or radiotherapy treatments for at least 30 days, although concomitant therapy with somatostatin analogues has been allowed;
• who, duly informed, gave their consent to the study by signing the informed consent form.

Saranno arruolati per il trattamento pazienti:
• di ambo i sessi;
• di età = 18 anni e = 85 anni;
• con diagnosi istologica e immuno-istochimica di tumore endocrino con limitazione ai distretti gastroenteropancreatico e bronchiale;
• grading (valutato in base all’indice di proliferazione cellulare con Ki-67 ( Mib1): 1 e 2 e 3 (restano escluse le forme indifferenziate con ki67 > 55%);
Per i NET bronchiali saranno arruolati carcinoidi tipici ed atipici senza limitazioni di ki67 purche positivi per i recettori sstr2.
• documentata elevata espressione di recettori per la somatostatina documentata mediante PET-TC con 68Ga-DOTATOC
• per i quali non siano proponibili trattamenti standard già documentati e di pari efficacia;
• con parametri ematologici, epatici e renali conservati, in particolare: GB = 2.5 10^9/L, Hb = 10 g/dl, PTL = 100.000 10^9/L, Bilirubina totale = 2.5 mg/dl, Creatinina = 2.0 md/dl;
• con malattia parametrabile secondo i criteri RECIST 1.1 mediante imaging convenzionale (TC o RMN) non antecedente a tre mesi rispetto all’arruolamento;
• che non hanno ricevuto trattamenti chemioterapici e/o radioterapici da almeno 30 giorni, pur essendo permesso concomitante terapia con analoghi della somatostatina;
• che, debitamente informati, abbiamo dato il loro libero assenso allo studio tramite firma del modulo di consenso informato.

E.4

Principal exclusion criteria

Will be excluded from the treatment of patients:

• not in possession of the above-mentioned requirements;
• pregnant or lactating;
• with proven bone marrow invasion (= 50%);
• previous RT emibody;
• with ECOG performance status> 2;
• with life expectancy <6 months.

Saranno esclusi dal trattamento pazienti:

• non in possesso dei requisiti sopra elencati;
• in stato di gravidanza o in fase di allattamento;
• con accertata invasione midollare (=50%);
• precedente RT emibody;
• con ECOG performance status > 2;
• con aspettativa di vita < 6 mesi.

E.5 End points

E.5.1

Primary end point(s)

Desease control

Controllo di malattia

E.5.1.1

Timepoint(s) of evaluation of this end point

12-18 months

12-18 mesi

E.5.2

Secondary end point(s)

OS, PFS, Adverse events

OS, PFS, Tossicità

E.5.2.1

Timepoint(s) of evaluation of this end point

2-6 years

2-6 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)

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

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

280

F.4.2

For a multinational trial

F.4.2.1

In the EEA

280

F.4.2.2

In the whole clinical trial

280

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)

Follow up

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

2017-11-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-11-15

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

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