Clinical Trials Register

Summary
EudraCT Number:	2021-004987-91
Sponsor's Protocol Code Number:	2020/ABM/01/00098
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-10-05
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2021-004987-91

A.3

Full title of the trial

Effects of calcium electroporation, electrochemotherapy, and irreversible electroporation (IRE-CaCl2, ECT and IRE) on quality of life and progression – free survival in patients with pancreatic cancer" (IREC).

Wpływ nieodwracalnej elektroporacji wapniowej, elektrochemioterapii oraz elektroporacji (IRE-CaCl2, ECT oraz IRE) na jakość życia oraz przeżycie wolne od progresji u chorych na raka trzustki” (IREC).

A.3.1

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

Effects of calcium electroporation, electrochemotherapy, and irreversible electroporation of life and progression in patients with pancreatic cancer.

Wpływ nieosdwracalnej elektroporacji wapomniowej, elektrochemioterapii oraz elektroporacji na jakość życia oraz przeżycie u chorych na raka trzustki.

A.4.1

Sponsor's protocol code number

2020/ABM/01/00098

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	Uniwersytet Medyczny im. Piastów Śląskich we Wrocławiu
B.1.3.4	Country	Poland
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	Agencja Badań Medycznych
B.4.2	Country	Poland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Maria Wołkowińska/Uniwersytet Medyczny im. Piastów Śląskich we Wrocławiu
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	Borowska 211 A
B.5.3.2	Town/ city	Wrocław
B.5.3.3	Post code	50-556
B.5.3.4	Country	Poland
B.5.4	Telephone number	4871784 06 99
B.5.6	E-mail	maria.wolkowinska@umw.edu.pl

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	Germany
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.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bleomycyni sulfas
D.3.9.1	CAS number	9041-93-4
D.3.9.4	EV Substance Code	SUB00844MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	up to
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	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	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	Poland
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.3.4	Pharmaceutical form	Solution for 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	Calcii chloridum
D.3.9.3	Other descriptive name	CALCIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB11767MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
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	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

Unresectable pancreatic cancer

Nieresekcyjny rak trzustki

E.1.1.1

Medical condition in easily understood language

Unresectable pancreatic cancer

Nieresekcyjny rak trzustki

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10033606
E.1.2	Term	Pancreatic cancer non-resectable
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

To evaluate efficacy and safety of irreversible electroporation (IRE), calcium (CaCl2) electroporation and electrochemotherapy (ECT) in patients with pancreatic cancer

Ocena skuteczności i bezpieczeństwa nieodwracalnej elektroporacji (IRE), elektroporacji z jonami wapnia (CaCl2) i elektrochemioterapii (ECT) u pacjentów chorych na raka trzustki.

E.2.2

Secondary objectives of the trial

To evaluate overall survival, decrease of body weight loss and decrease of pain level, as well as quality of life improvement

Exploratory objectives:
- Biomarkers analysis (Ca 19-9).
- Morphology and biochemistry analysis (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin).
- The inflammatory response in IRE (irreversible electroporation), ECT (electrochemotherapy) and CaEP (calcium electroporation).

Ocena całkowitego przeżycia (overall survival), zmniejszenia utraty masy ciała, zmniejszenia poziomu bólu oraz poprawa jakości życia.

Cele eksploracyjne:
- Analiza biomarkerów (Ca 19-9).
- Analiza parametrów morfologicznych oraz biochemicznych (w tym m.in., poziom albuminy, białka, lipazy, amylazy, CRP i prokalcytoniny).
- Reakcja zapalna w IRE (nieodwracalnej elektroporacji), ECT (elektrochemioterapii) i CaEP (elektroporacji wapnia).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age over 18 years (male and female)
2. Written informed consent
3. Histopathological confirmed adenocarcinoma of the pancreas (intraoperative examination possible)
4. Lesion defined as unresectable (infiltration of mesenteric or portal vein exceeding 180 degrees or its thrombosis, infiltration of the hepatic artery, celiac artery or superior mesenteric artery) on abdominal CT/MRI not older than 60 days (stage III), or patients after resection with local recurrence of the neoplastic process
5. Tumor size not larger than 6 cm on a CT/MRI scan not older than 60 days
6. Patients undergoing chemotherapy or patients with a “de novo” diagnosis of pancreatic cancer
7. ECOG performance status: 0,1 or 2

1. Wiek powyżej 18 lat (mężczyzna i kobieta);
2. Pisemna świadoma zgoda pacjenta na udział w badaniu;
3. Histopatologicznie potwierdzony gruczolakorak trzustki (możliwe badanie śródoperacyjne);
4. Zmiana zdefiniowana jako nieoperacyjna (naciek żyły krezkowej lub wrotnej powyżej 180 stopni lub jej zakrzepica, naciek tętnicy wątrobowej, trzewnej lub tętnicy krezkowej górnej) w TK/MRI jamy brzusznej nie starszej niż 60 dni (stadium III) lub pacjenci po resekcji z miejscowym nawrotem procesu nowotworowego;
5. Wielkość guza nie większa niż 6 cm w TK/MRI nie starszym niż 60 dni;
6. Pacjenci poddawani chemioterapii lub pacjenci z rozpoznaniem „de novo” raka trzustki;
7. Status sprawności ECOG 0,1 lub 2.

E.4

Principal exclusion criteria

1. Age under 18 years.
2. Inability to give consent in writing.
3. Pregnant or lactating women
4. Significant cardiac abnormality (rhythm other than sinus rhythm).
5. Patients with pacemakers or any implanted stimulation device.
6. Allergy to contrast media that would compromise the ability to perform imaging after surgery.
7. Documented history of allergy to bleomycin.
8. Documented history of pulmonary fibrosis.
9. Patient with metastatic stage IV disease.
10. INR > 1,5 without use of anticoagulants.
11. Body temperature >38°C or any infection requiring antibiotic therapy within 24 hours prior to study treatment.
12. Overuse or addiction to alcohol, drugs or any other substances (caffeine and nicotine excluded).
13. Any circumstances, that in the Investigator’s judgement may prevent the patient from participating in the study, undergoing the study assessments in accordance with the protocol or bear unjustified risk to the patient

1. Wiek poniżej 18 lat;
2. Brak możliwości udzielenia pisemnej świadomej zgody;
3. Kobiety w ciąży lub w okresie laktacji;
4. Istotna nieprawidłowość serca (rytm inny niż rytm zatokowy);
5. Pacjenci z rozrusznikami serca lub jakimkolwiek wszczepionym urządzeniem stymulującym;
6. Alergia na środki kontrastowe, która zagroziłaby możliwości wykonania obrazowania po zabiegu;
7. Udokumentowana historia alergii na bleomycynę;
8. Udokumentowana historia zwłóknienia płuc;
9. Pacjent z przerzutową chorobą w IV stopniu zaawansowania;
10. INR > 1,5 bez użycia antykoagulantów;
11. Temperatura pacjenta >38oC lub infekcja wymagająca antybiotykoterapii w ciągu 24 godzin przed rozpoczęciem leczenia badania;
12. Nadużycie lub uzależnienie od alkoholu, narkotyków czy wszelkich innych substancji (wyłączając kofeinę i nikotynę).
13. Każda sytuacja, która w opinii Badacza może uniemożliwić pacjentowi udział w badaniu, przeprowadzenie pacjentowi procedur badania zgodnie z protokołem badania lub nieść nieuzasadnione ryzyko dla pacjenta.

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival (PFS) defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.

Przeżycie wolne od progresji (PFS) zdefiniowana jako czas od rozpoczęcia leczenia badania do pierwszego wystąpienia progresji choroby lub zgonu z jakiejkolwiek przyczyny, którekolwiek wystąpi pierwsze.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 month, 3 month and 6 month, and 12 months after treatment. Thereafter, by telephone, every 6 months until the Sponsor announces the end of the study.

1 miesiąc, 3 miesiąc i 6 miesiąc oraz 12 miesięcy po zabiegu. Następnie telefonicznie, co 6 miesięcy, aż do ogłoszenia zakończenia badania przez Sponsora.

E.5.2

Secondary end point(s)

1. Patient overall survival (OS) defined as the proportion of patients remaining alive from the initiation of study treatment until the last follow-up visit.
2. Body weight change in predefined timepoints
3. Pain level (VAS scale)
4. Quality of life EORTC QLQ-PAN26 and WHOQOL-BREF

Exploratory endpoints:

1. Levels of biomarkers (Ca 19-9 in 1,4, 6 days after surgery [+/- 1 day] and during standard follow-up visits)
2. Changes in morphology and biochemistry panel (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin) at the timepoints described by schedule of assessments.
3. Progression-free survival (PFS) defined as the time from the diagnosis to the first occurrence of disease progression or death from any cause, whichever occurs first.
4. Patient overall survival (OS) defined as the proportion of patients remaining alive from the diagnosis until the last follow-up visit.

1. Całkowite przeżycie pacjenta (OS) zdefiniowane jako proporcja pacjentów pozostających przy życiu od rozpoczęcia leczenia badania do ostatniej wizyty kontrolnej.
2. Zmiana masy ciała w określonych punktach czasowych.
3. Poziom bólu (skala VAS).
4. Jakość życia EORTC QLQ - PAN26 i WHOQOL-BREF

Eksploracyjne punkty końcowe:
1. Poziomy biomarkerów (Ca 19-9 w 1,4,6 dobie po zabiegu [+/- 1 dzień] oraz podczas standardowych wizyt kontrolnych).
2. Zmiany w morfologii i panelu biochemicznym (w tym m.in. poziom albuminy, białka, lipazy, amylazy, CRP, prokalcytoniny) w punktach czasowych opisanych przez harmonogram wizyt.
3. Przeżycie wolne od progresji (PFS) zdefiniowane jako czas od rozpoznania do pierwszego wystąpienia progresji choroby lub zgonu z jakiejkolwiek przyczyny, w zależności od tego, co nastąpi pierwsze.
4. Całkowite przeżycie pacjenta (OS) zdefiniowane jako odsetek pacjentów pozostających przy życiu od momentu rozpoznania do ostatniej wizyty kontrolnej.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 month, 3 month and 6 month, and 12 months after treatment. Thereafter, by telephone, every 6 months until the Sponsor announces the end of the study.

1 miesiąc, 3 miesiąc i 6 miesiąc oraz 12 miesięcy po zabiegu. Następnie telefonicznie, co 6 miesięcy, aż do ogłoszenia zakończenia badania przez Sponsora.

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

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

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

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

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)

After end of study patients will be treated according to standard of care

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

2021-11-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-10-14

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

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