Clinical Trials Register

Summary
EudraCT Number:	2018-001224-19
Sponsor's Protocol Code Number:	1/0196/16
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-12-07
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2018-001224-19

A.3

Full title of the trial

Non-invasive in-vivo prediction of therapeutic response to inhibitors of angiogenesis using gallium (68Ga) NODAGA-RGD PET/CT

Neinvazívna in-vivo predikcia odpovede na terapiu inhibítormi angiogenézy pomocou PET/CT s gálium (68Ga) NODAGA-RGD

A.3.1

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

Non-invasive in-vivo prediction of therapeutic response to inhibitors of angiogenesis using gallium (68Ga) NODAGA-RGD PET/CT

Neinvazívna in-vivo predikcia odpovede na terapiu inhibítormi angiogenézy pomocou PET/CT s gálium (68Ga) NODAGA-RGD

A.3.2

Name or abbreviated title of the trial where available

Angio PET

A.4.1

Sponsor's protocol code number

1/0196/16

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	Lekárska fakulta Univerzity Komenského v Bratislave
B.1.3.4	Country	Slovakia
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	Faculty of Medicine in Bratislava of Comenius University in Bratislava
B.4.2	Country	Slovakia
B.4.1	Name of organisation providing support	Scientific Grant Agency of the Ministry of Education, science, research and sport of the Slovak Republic
B.4.2	Country	Slovakia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Faculty of Medicine in Bratislava of Comenius University in Bratislava
B.5.2	Functional name of contact point	Department of Nuclear Medicine
B.5.3	Address:
B.5.3.1	Street Address	Heydukova 10
B.5.3.2	Town/ city	Bratislava
B.5.3.3	Post code	81250
B.5.3.4	Country	Slovakia
B.5.4	Telephone number	+421232249129
B.5.5	Fax number	+421232249131
B.5.6	E-mail	sona.balogova@ousa.sk

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	IASON RGD 20 MBq/mL, solution for injection
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	gallium (68Ga) NODAGA-RGD
D.3.9.3	Other descriptive name	68GA-NODAGA-RGD
D.3.9.4	EV Substance Code	SUB130779
D.3.10	Strength
D.3.10.1	Concentration unit	MBq/ml megabecquerel(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	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

Advanced metastatic cancer of the colon or rectum

Pokročilý metastatický karcinóm hrubého čreva alebo konečníka

E.1.1.1

Medical condition in easily understood language

Advanced metastatic cancer of the colon or rectum

Pokročilý metastatický karcinóm hrubého čreva alebo konečníka

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10009956
E.1.2	Term	Colon cancer stage IV
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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10055114
E.1.2	Term	Colon cancer metastatic
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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10010035
E.1.2	Term	Colorectal cancer stage IV
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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10052358
E.1.2	Term	Colorectal cancer metastatic
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

1. To compare the response rate to treatment including antiangiogenic agent in patients with advanced metastatic cancer of the colon or rectum , according to whether or not all known lesions, were visually positive on gallium (68Ga) NODAGA-RGD PET/CT before starting treatment including antiangiogenic agent

1. Porovnať frekvenciu odpovede na liečbu zahŕňajúcu liek s antiangiogénnym účinkom u pacientov s pokročilým metastatickým karcinómom hrubého čreva alebo konečníka, podľa toho, či boli všetky známe lézie vizuálne pozitívne na PET/CT s gálium (68Ga) NODAGA-RGD pred iniciáciou liečby zahŕňajúcej liek s antiangiogénnym účinkom

E.2.2

Secondary objectives of the trial

1. To validate and improve the interpretation criteria for gallium (68Ga) NODAGA-RGD PET/CT

2. To check the perfect tolerability of gallium (68Ga) NODAGA-RGD

1. Validovať a optimalizovať interpretačné kritériá pre PET/CT s gálium (68Ga) NODAGA-RGD

2. Overiť výbornú toleranciu gálium (68Ga) NODAGA-RGD

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

In order to be eligible to participate in this study, all individual must meet all of the following criteria:
1. Male or female over 18 years of age with histologicaly confirmed metastatic cancer of the colon or rectum fulfilling the following criteria :
a) Scheduled for treatment including antiangiogenic agent
b) At least one measurable lesions according to RECIST 1.1 criteria (>10mm in long axis for non-lymph node lesions and >15mm in short axis for lymph node lesions).
c) Availability of following examination data in DICOM III format performed less than 31 days prior inclusion:
- Diagnostic CT of thorax, abdomen and pelvis
- Fludeoxyglucose (18F) PET/CT
2. Capable of staying still in lying position for the duration of the PET/CT acquisition which can last up to 30 min in all, a "whole body" acquisition
3. ECOG performance status ≤ 2 at inclusion
4. Patient with a life expectancy ≥ 24 weeks from baseline
5. For women of childbearing age, the possibility of pregnancy should be ruled out at inclusion
6. Volunteer and able to follow the instructions necessary for the study
7. Having signed an informed consent to participate in the study

Na zaradenie do tejto štúdie musí každý jednotlivec spĺňať všetky nasledovné kritériá:
1. Muž alebo žena staršia ako 18 rokov s histologicky potvrdeným pokročilým metastatickým karcinómom hrubého čreva alebo konečníka spĺňajúcim nasledovné kritériá:
a) Plánovaná na liečba zahŕňajúca inhibítor angiogenézy
b) Aspoň jedna merateľná lézia podľa kritérií RECIST 1.1 (> 10 mm v dlhej osi pre lézie mimo lymfatických uzlín a> 15 mm v krátkej osi pre uzlinové lézie).
c) Dostupnosť nasledujúcich údajov o vyšetrení vo formáte DICOM III vykonaných menej ako 31 dní pred zaradením:
- CT hrudníka, brucha a panvy
- PET/CT s fludeoxyglukózou (18F)
2. Pacient schopný zostať v ležiacej polohe počas snímania obrazov PET/CT, čo môže trvať do 30 minút pre celotelové snímanie
3. Stav výkonnosti ECOG ≤ 2 pri zaradení do štúdie
4. Pacient s očakávanou dĺžkou života ≥ 24 týždňov od zaradenia do štúdie
5. U žien vo fertilnom veku sa má pri začlenení vylúčiť možnosť tehotenstva
6. Pacient ochotný a schopný dodržať pokyny potrebné pre realizáciu štúdie
7. Podpis informovaného súhlasu s účasťou na štúdii

E.4

Principal exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergy to components of the study product
- Treatment scheduled does not include antiangiogenic agent
- Life expectancy less than 6 months
- ECOG Performance Status >2 or Karnofsky Performance Status <50%

Jednotlivec spĺňajúci niektoré z nasledujúcich kritérií bude vylúčený z účasti na tejto štúdii:
- Tehotenstvo alebo laktácia
- Známa alergia na niektorú zo zložiek skúmaného produktu
- Plánovaná liečba nezahŕňa liek s antiangiogénnym účinkom
- Očakávaná dĺžka života je kratšia ako 6 mesiacov
- Stav výkonnosti ECOG> 2 alebo stav výkonnosti Karnofsky <50%

E.5 End points

E.5.1

Primary end point(s)

1. Assessment of value of gallium (68Ga) NODAGA-RGD PET/CT to predict the response to treatment including antiangiogenic agent

2. Stanovenie prediktívnej hodnoty PET/CT s gálium (68Ga) NODAGA-RGD pre odpoveď na liečbu zahŕňajúcu liek s antiangiogénnym účinkom

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months after gallium (68Ga) NODAGA-FGD and at least two cycles of treatment including antiangiogenic agent.

6 mesiacov po PET/CT s gálium (68Ga) NODAGA-RGD a po minimálne dvoch cykloch liečby zahŕňajúcej liek s antiangiogénnym účinkom

E.5.2

Secondary end point(s)

1. Refinement of criteria for interpretation of gallium (68Ga) NODAGA-RGD PET/CT

2. Confirmation of perfect tolerability of gallium (68Ga) NODAGA-RGD

1. Optimalizácia interpretačných kritérií pre PET/CT s gálium (68Ga) NODAGA-RGD

2. Potvrdenie výbornej tolerancie gálium (68Ga) NODAGA-RGD

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 6 months after gallium (68Ga) NODAGA-RGD and at least two cycles of treatment including antiangiogenic agent.

2. During, immediately after and up to 24 after administration of gallium (68Ga) NODAGA-RGD

1. 6 mesiacov po PET/CT s gálium (68Ga) NODAGA-RGD a po minimálne dvoch cykloch liečby zahŕňajúcej liek s antiangiogénnym účinkom

2. Počas, bezprostredne po a do 24 hodín po podaní gálium (68Ga) NODAGA-RGD

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

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)

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

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

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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 different from the expected normal treatment of given condition.

Nie je odlišná od očkávanej bežnej liečby pri danom ochorenií.

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

2019-02-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-11-14

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

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