Clinical Trials Register

Summary
EudraCT Number:	2013-002605-65
Sponsor's Protocol Code Number:	DOTA2013/DOTATER
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:	2013-10-02
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

2013-002605-65

A.3

Full title of the trial

Radioreceptor therapy with labeled somatostatin analogues in tumors with high expression of somatostatin receptors.

Terapia radiorecettoriale con analoghi marcati della somatostatina in tumori con elevata espressione dei recettori per la somatostatina.

A.3.1

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

Radioreceptor therapy with labeled somatostatin analogues in tumors with high expression of somatostatin receptors.

Terapia radiorecettoriale con analoghi marcati della somatostatina in tumori con elevata espressione dei recettori per la somatostatina.

A.3.2

Name or abbreviated title of the trial where available

DOTA2013/DOTATER

A.4.1

Sponsor's protocol code number

DOTA2013/DOTATER

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 Ospedaliera di Reggio Emilia Arcispedale S.Maria Nuova/IRCCS
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	Azienda Ospedaliera di Reggio Emilia Arcispedale S.Maria Nuova/IRCCS
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	Azienda Ospedaliera di Reggio Emilia Arcispedale S.Maria Nuova/IRCCS
B.5.2	Functional name of contact point	S.C. di Medicina Nucleare
B.5.3	Address:
B.5.3.1	Street Address	V.le Risorgimento, 80
B.5.3.2	Town/ city	Reggio Emilia
B.5.3.3	Post code	42123
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390522296313
B.5.5	Fax number	00390522296153
B.5.6	E-mail	annibale.versari@asmn.re.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	Analogo Somatostatina marcato con 90Yttrium- DOTA (Tyr3)- octreotate 177 Lutetium DOTA (Tyr3)
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Kit for radiopharmaceutical preparation
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	Lutetium-177
D.3.9.1	CAS number	14265-75-9
D.3.9.2	Current sponsor code	ITG Lu-177 n.c.a.
D.3.9.3	Other descriptive name	Lutetium, isotope of mass 177
D.3.9.4	EV Substance Code	SUB38329
D.3.10	Strength
D.3.10.1	Concentration unit	Ci/ml curie(s)/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ittrio-90
D.3.9.1	CAS number	10098-91-6
D.3.9.2	Current sponsor code	NEZ-306AG
D.3.9.3	Other descriptive name	YTTRIUM (90Y) CHLORIDE
D.3.9.4	EV Substance Code	SUB20378
D.3.10	Strength
D.3.10.1	Concentration unit	Ci/ml curie(s)/millilitre
D.3.10.2	Concentration type	up to
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	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 tumors expressing somatostatin receptors.

Pazienti con tumori esprimenti recettori della somatostatina.

E.1.1.1

Medical condition in easily understood language

Cancer patients with high expression of somatostatin receptors (neuroendocrine tumors, thyroid tumors, lung tumors, meningiomas, etc.)

Pazienti con neoplasia ad elevata espressione di recettori della somatostatina (es. tumori neuroendocrini, tumori della tiroide, tumori polmonari, meningiomi, ecc)

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

Correlate the dosimetric results of each lesion "target" with the response of the lesion to the radioreceptor therapy (PRRT) in patients with cyto-histological diagnosis of cancer or other neuroendocrine tumors expressing somatostatin receptors.

Correlare i risultati dosimetrici di ogni lesione “target” con la risposta della lesione stessa alla terapia radiorecettoriale (PRRT) in pazienti con diagnosi cito-istologica di tumore neuroendocrino o altro tumore esprimente i recettori della somatostatina.

E.2.2

Secondary objectives of the trial

Correlate the dosimetric results of BED to the kidney and dose to the spinal forecast with nephrotoxicity and hematologic toxicity determined by the PRRT.

Correlare i risultati dosimetrici di BED al rene e dose previsionale al midollo con la nefrotossicità e la tossicità ematologica determinati dalla PRRT.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients age > 18 years old and either gender or ethnicity
Cyto-histological diagnosis of NET or other SSTR-positive tumors (brain tumor cancer, colon cancer, differentiated thyroid carcinoma, lymphoma, breast cancer, melanoma, lung cancer, renal cancer, sarcoma, prostate cancer, hepatocellular carcinoma, thymic neoplasms)
Presence of at least one measurable lesion> 1 cm
High expression of somatostatin receptors in the 68Ga-SST-A PET / CT in / lesion and / i "target". It is defined as "high expression of somatostatin receptors" demonstration examination 68Ga-SST-A PET / CT (semi-quantitative analysis) in a ratio of SUVmax tumor / muscle SUVmean> 4:1.
Examination CT with contrast or MRI <2 months of enrollment in this clinical study
Adequate serum chemistry values: white blood cell count> 2500/μL, platelets> 90000/μL; hemoglobin> 9 g / dL, creatinine <2 mg / dl, bilirubin <2.5 mg / dL
ECOG performance status ≤ 2
Written informed consent

Pazienti di età>18 anni e qualunque sesso o etnia
Diagnosi cito-istologica di NET o di altro tumore SSTR-positivo (tumore cerebrale, tumore del colon-retto, carcinoma differenziato della tiroide, linfoma, tumore della mammella, melanoma, tumore del polmone, neoplasia renale, sarcoma, tumore della prostata, epatocarcinoma, neoplasie timiche)
Presenza di almeno una lesione misurabile> 1 cm
Elevata espressione dei recettori per la somatostatina alla 68Ga-SST-A PET/TC nella/e lesione/i “target”. Si definisce come “elevata espressione dei recettori per la somatostatina” la dimostrazione all’esame 68Ga-SST-A PET/TC (analisi semi-quantitativa) di un rapporto di SUVmax tumore/SUVmean muscolo > 4:1.
Esame TC con mezzo di contrasto o RM <2 mesi dall’arruolamento nel presente studio clinico
Adeguati valori ematochimici: globuli bianchi >2500/µL; piastrine > 90000/µL; emoglobina > 9 gr/dL; creatinina < 2 mg/dL; bilirubina < 2.5 mg/dL
ECOG performance status ≤ 2
Firma del consenso informato

E.4

Principal exclusion criteria

Pregnancy status
In case of breastfeeding, refuse to stop breastfeeding
Surgery, chemotherapy, radiation therapy, or biological drugs in the 4 weeks preceding the PRRT (except radiotherapy with palliative intent of symptomatic lesions in patients plurimetastatici).
Participation in another clinical protocol experimental therapy within 4 weeks before the PRRT
Invasion of bone marrow disease ascertained> 25%
Patients with other therapeutic option validated as an effective
Life expectancy <6 months

Stato di gravidanza
In caso di allattamento, rifiuto di sospendere l’allattamentoChirurgia, chemioterapia, radioterapia o terapia con farmaci biologici nelle 4 settimane precedenti la PRRT (eccetto il trattamento radioterapico con intento palliativo di lesioni sintomatiche in pazienti plurimetastatici).
Partecipazione ad altro protocollo clinico sperimentale terapeutico nelle 4 settimane precedenti la PRRT
Invasione midollare di malattia accertata >25%
Pazienti con altra opzione terapeutica validata come efficace
Aspettativa di vita < 6 mesi

E.5 End points

E.5.1

Primary end point(s)

Assess for all patients undergoing PRRT survival at 3 and 6 months, the PFS and
ORR.

Valutare in tutti i pazienti sottoposti a PRRT la sopravvivenza a 3 e 6 mesi, la PFS e l’ORR.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 and 6 months.

3 e 6 mesi.

E.5.2

Secondary end point(s)

Correlate the response to PRRT with the degree of histological differentiation at the time of diagnosis and the stage of disease at enrollment in this clinical study.

Correlare la risposta alla PRRT con il grado di differenziazione istologico al momento della diagnosi e lo stadio di malattia al momento dell’arruolamento nel presente studio clinico.

E.5.2.1

Timepoint(s) of evaluation of this end point

3 and 6 months.

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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.1.1.1

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-10-02.

Yes

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

100

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)

NONE

Nessuno

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

2013-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-16

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

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