Clinical Trials Register

Summary
EudraCT Number:	2017-000940-17
Sponsor's Protocol Code Number:	64Cu
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:	2018-01-22
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

2017-000940-17

A.3

Full title of the trial

Phase IIa clinical study of 64 CuCl2: efficacy and safety of a new tracer for urologic tumors

A.3.1

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

Efficacy and safety of a new tracer for urologic tumors

A.4.1

Sponsor's protocol code number

64Cu

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information

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	Cupymina
D.2.1.1.2	Name of the Marketing Authorisation holder	SPARKLE srl
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.3.1	Product name	Cuprymina
D.3.4	Pharmaceutical form	Injection
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	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

Genitourinary tract tumors in male patients

E.1.1.1

Medical condition in easily understood language

Tumors of urinary and reproductive systems in male patients

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

Efficacy (sensibility patient based of total body PET/TC scan after CuCl2 somministration) and tradiotracer safety (based on assessment of frequency and features of possible adverse events).

E.2.2

Secondary objectives of the trial

1) lesion-based sensitivity of whole body PET/TC scan after CuCl2 somministration in primary and metastatic lesions.
2) Techincal performance evaluation of CuCl2 PET/TC scan [target/background (T/B) contrast]

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Over 18 y/o patients at enrolling;
2. Patient afflicted with kidney, bladder or penis neoplasm elegible for demolitive surgery;
3. Histologically documented prostate cancer afflicted patients, in treatment with ADT (orchiectomy and/or LHRH agonists and/or androgen antagonists); patients with diagnosis of metastatic prostate cancer, detectable at re-staging TC scan too; recent disease progression (serial PSA increasing and/or clinical or radiological progression), under ADT, with clinical indication to restaging, even radiological.
4. Availability of a re-staging whole body CT scan (with and without contrast media) executed in 20 days prior to the enrollement (slice thickness < 5mm);
5. Availability of:
- re-staging whole body CT scan (with and without contrast media) executed 8 months prior to the enrollement visit (slice thickness < 5mm);
- At least one of the following functional and metabolism imaging exams, executed as clinically indicated restaging, 20 days prior to the enrollement:
 MRI (ossea),
 18F-FCH PET/CT,
 99mTc-HDP (SPECT)
 18F-FDG PET/CT;
6. No clinical history of other neoplasms (previously or at time of the enrollement), execpt non-melanoma skin carcinomas.
7. Karnofski index >80%
8. Absence of relevant comorbidities
9. Plain fitness to plead all the informations given in the Subject Illustration Documentation.
10. Plain fitness to subscribe an effective informd consent.

E.4

Principal exclusion criteria

1. Anemia (Hb<10 g/dL)
2. Presence of symptoms or signs of sepsis and/or acute infections
3. AST more than 1.5 times higher than normality range limit
4. ALT more than 1.5 times higher than normality range limit
5. total bilirubin more than 1.5 times higher than normality rage limit
6. Clinical History or analytic evidence of HBV infection
7. Clinical History or analytic evidence of HCV infection

8. KCD more severe than stage II (eGRF< 60 ml/min calculated with MDRD equation)
9. TIA or Ictus less than six months before enrollement
10. Diagnosis of neurodegenerative disease
11. Other chronic CNS diseases
12. Clinical history of psychiatric pathology or therapeutical usage of major psychopharmacological drugs
13. ACS less than six months before enrollement
14. heart failure NYHA>1 or LVEF< 50%, clinically documentable
15. Valvulopathy with indication to surgical correction
16. Chronic respiratory disease with significative functional limitiation
17. Cupper metabolism diseases
18. Diabetes Mellitus under insuline therapy
19. Subjects who have received Chemiotherapics
20. Subjects underwent radiotherapy in the 120 days before enrolling
21. Subjects underwent major srgery interventions in the 120 days before enrolling
22. BMI> 28
23. Previous partecipation to clinical trials involving exposure to ionizing radiations with therapeutical purposes.
24. Work related exposure to ionising radiations
25. Any material, logistical or subjective condition that, even in the opinion of the principle experimenter, could condition subject’s compliance to execution of any of the procedures expected by the protocol
26. Subject’s inhability to understand informative documentation content.
27. Pregnancy - Mandatory negative pregnancy test for women in fertile age.

E.5 End points

E.5.1

Primary end point(s)

Efficacy (sensibility patient based of total body PET/TC scan after CuCl2 somministration) and tradiotracer safety (based on assessment of frequency and features of possible adverse events).

E.5.1.1

Timepoint(s) of evaluation of this end point

15 days

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days

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

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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.8.3

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

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)

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

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