Clinical Trials Register

Summary
EudraCT Number:	2023-000128-12
Sponsor's Protocol Code Number:	GinOnc-ECT
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:	2023-02-06
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

2023-000128-12

A.3

Full title of the trial

Single-center phase II study on the use of electrochemotherapy in the treatment of Paget's disease and high-grade or initially invasive precancerous squamous lesions of the vulva (GinOnc-ECT study)

Studio di fase II monocentrico sull’utilizzo dell’elettrochemioterapia nel trattamento del M. di Paget e delle lesioni squamose precancerose di alto grado o inizialmente invasive della vulva (GinOnc-ECT study)

A.3.1

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

Single-center phase II study on the use of electrochemotherapy in the treatment of Paget's disease and high-grade or initially invasive precancerous squamous lesions of the vulva (GinOnc-ECT study)

A.3.2

Name or abbreviated title of the trial where available

GinOnc-ECT

A.4.1

Sponsor's protocol code number

GinOnc-ECT

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	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione Policlinico Universitario A. Gemelli IRCCS
B.5.2	Functional name of contact point	Direzione Scientifica
B.5.3	Address:
B.5.3.1	Street Address	L.go A Gemelli 8
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.6	E-mail	direzione.scientifica@policlinicogemelli.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	Yes
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	cisplatino
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intratumoral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	cisplatino
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
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	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	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.IMP: 2
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.2.1.2	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	Bleomicina
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Local use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bleomicina
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15000
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	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	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

patients with newly diagnosed or recurrent high-grade or initially invasive precancerous squamous lesions of the vulva and non-invasive vulvar Paget's disease

pazienti con nuova diagnosi o recidiva di lesioni squamose precancerose di alto grado o inizialmente invasive della vulva e di malattia di Paget vulvare non invasivo

E.1.1.1

Medical condition in easily understood language

patients with newly diagnosed or recurrent high-grade or initially invasive precancerous squamous lesions of the vulva and non-invasive vulvar Paget's disease

pazienti con nuova diagnosi o recidiva di lesioni squamose precancerose di alto grado o inizialmente invasive della vulva e di malattia di Paget vulvare non invasivo

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	LLT
E.1.2	Classification code	10051963
E.1.2	Term	Vulvar carcinoma
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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10033369
E.1.2	Term	Paget's disease of the vulva
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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of the activity of electrochemotherapy in the treatment of vulvar lesions and non-invasive Paget's disease

Valutazione dell’attività della elettrochemioterapia nel trattamento delle lesioni vulvari e M. di Paget non invasivo

E.2.2

Secondary objectives of the trial

• Evaluation of the safety of electrochemotherapy
• Evaluation of the control of the presence of HPV
• Follow-up evaluation of vulvar VIN 2-3 and non-invasive Paget's disease
• Evaluation of the symptoms reported by the patient

• Valutazione della safety della elettrochemioterapia
• Valutazione del controllo della presenza di HPV
• Valutazione del follow-up di VIN 2-3 vulvare e del M. di Paget non invasivo
• Valutazione della sintomatologia riportata dalla paziente

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Histological diagnosis of de novo or recurrent squamous disease of vulvar VIN 2-3, microinvasive carcinoma in situ of the vulva, and noninvasive vulvar Paget's disease
• Positivity for cervical and/or vaginal HR HPV
• Age > 18 years
• Karnofsky performance status >70%
• Informed consent to participate in the study
• Absence of indication for surgical treatment due to extension of the disease, due to patient refusal, for anaesthesiological or reconstructive reasons.

• Diagnosi istologica di malattia squamosa insorta de novo o recidivante di VIN 2-3 vulvare, carcinoma in situ micro-invasivo della vulva e Malattia di Paget non invasiva vulvare
• Positività per HPV HR cervicale e/o vaginale
• Età > 18 anni
• Karnofsky performance status >70%
• Consenso informato alla partecipazione allo studio
• Assenza di indicazione al trattamento chirurgico per estensione della malattia, per rifiuto della paziente, per motivi anestesiologici o ricostruttivi.

E.4

Principal exclusion criteria

• Patients with histological diagnosis of adenocarcinoma
• Patients with concomitant and/or previous tumours
• Pregnancy in progress
• Chronic renal failure
• Patients with cardiac pacemakers
• Epilepsy
• Pulmonary pathologies with medium/severe respiratory insufficiency
• Coagulation disorders (platelets < 70,000/mm3 and INR>1.5)
• HPV vaccination in progress
• Patients with immunosuppressive diseases or treatments (HIV positive)

• Pazienti con diagnosi istologica di adenocarcinoma
• Pazienti con tumori concomitanti e/o pregressi
• Gravidanza in atto
• Insufficienza renale cronica
• Pazienti portatrici di pace-maker cardiaco
• Epilessia
• Patologie polmonari con insufficienza respiratoria di grado medio/severo
• Alterazioni della coagulazione (piastrine < 70.000/mmc e INR>1.5)
• Vaccinazione HPV in corso
• Pazienti con patologie o trattamenti immunosoppressivi (HIV positive)

E.5 End points

E.5.1

Primary end point(s)

Evaluation of histological pathological response of vulvar lesions and non-invasive Paget's disease on surgical specimens 30 days after electrochemotherapy according to RECIST criteria

Valutazione della risposta patologica istologica delle lesioni vulvari e M. di Paget non invasivo su campioni chirurgici dopo 30 giorni dalla elettrochemioterapia in base ai criteri RECIST

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days

30 giorni

E.5.2

Secondary end point(s)

Safety of the method evaluated using the CTCAE criteria v. 5.0; Assessment of HPV persistence by HPV test at the 6-month visit; Duration of disease control in follow-up; Symptomatology assessment using specific questionnaires (VAS, EQ-5D, FSFI) filled in by patients before treatment and one, three, six and twelve months after treatment

Sicurezza della metodica valutata mediante i criteri CTCAE v. 5.0; Valutazione persistenza di HPV mediante test HPV alla visita a 6 mesi; Durata del controllo di malattia nel follow-up; Valutazione della sintomatologia mediante appositi questionari (VAS, EQ-5D, FSDS) compilati dalle pazienti prima il trattamento ed a uno, tre, sei e dodici mesi dopo il trattamento

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days; 6 months; 2 anni; 12 months

30 giorni; 6 mesi; 2 anni; 12 mesi

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

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

Yes

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

Yes

E.8.2.3.1

Comparator description

nessuno

none

E.8.2.4

Number of treatment arms in the trial

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.8.4.1

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

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)

clinical practice

pratica 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

2023-04-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-23

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

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