Clinical trial • Phase III • Oncology

IRINOTECAN HYDROCHLORIDE for Hepatoblastoma | Hepatocellular carcinoma

Phase III trial of IRINOTECAN HYDROCHLORIDE for Hepatoblastoma | Hepatocellular carcinoma. 60 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Hepatoblastoma | Hepatocellular carcinoma
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
16-09-2024
First CTIS Authorization Date
05-11-2024

Trial design

Phase III trial across 14 sites in Poland.

Target Sample Size
60

Eligibility

Recruits 60 paediatric patients.

Pregnancy Exclusion
Pregnancy or breastfeeding
Vulnerable Population
Vulnerable population: children and adolescents. The trial includes age-specific subject information and informed consent forms and parent/guardian forms (e.g. documents titled '23_07_17_Ogolna informacja o badaniu dla pacjenta 8_12 lat clean', 'POLPHITT_pacjent 13', and multiple 'POLPHITT_rodzic_*' parent versions). Consent is obtained from parent/guardian with age-appropriate information and assent procedures for minors as per the age-specific documents (documents available in Polish).

Inclusion criteria

  • {"criterion_text":"- Clinically signs of Hepatoblastoma or Hepatocarcinoma (malignant tumors of the liver) + liver tumor; Age under 30; Signing informed consent to participate in the Study"}

Exclusion criteria

  • {"criterion_text":"- Previously or currently receiving chemotherapy treatment; Recurrence of the disease; Condition after organ transplantation; Uncontrolled generalized infection; Inability to conduct the Study in accordance with the Protocol; Other Associated Cancer; Pregnancy or breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- event-free survival\n- overall survival\n- adherence to surgical guidelines\n- chemotherapy-related toxicity\n- hearing loss\n- response\n- failure-free survival\n- surgical resectability.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
60
Recruitment Window Months
51
Consent Approach
Informed consent is obtained using age-specific subject information and consent forms. Documents include participant information and consent templates for children aged 8-12, forms for patients aged 13 and older, and multiple parent/guardian information and consent forms (document titles such as '23_07_17_Ogolna informacja o badaniu dla pacjenta 8_12 lat clean', 'POLPHITT_pacjent 13', 'POLPHITT_rodzic_*'). Consent is provided by parent/guardian with assent from minors according to the age-specific forms. Documents appear in Polish.

Geography

Total Number Of Sites
14
Total Number Of Participants
60

Poland

Earliest CTIS Part Ii Submission Date
06-10-2024
Latest Decision Or Authorization Date
05-06-2025
Processing Time Days
242
Number Of Sites
14
Number Of Participants
60

Sites

Site Name
Uniwersytecki Dziecięcy Szpital Kliniczny im. Ludwika Zamenhofa w Białymstoku
Department Name
Klinika Pediatrii, Onkologii i Hematologii
Contact Person Name
Małgorzata Sawiska-Żukowska
Site Name
Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie
Department Name
Klinika Onkohematologii Dziecięcej
Contact Person Name
Radosław Chaber
Site Name
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Department Name
Klinika Pediatrii, Onkologii i Hematologii
Contact Person Name
Monika Zjawiona
Site Name
Uniwersytecki Szpital Klinicznym Nr 1 Pomorskiego Uniwersytetu Medycznego
Department Name
Klinika Pediatrii, Onkologii i Immunologii Dziecięcej
Contact Person Name
Paweł Wawryków
Contact Person Email
pawel.wawrykow@gmail.com
Site Name
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy
Department Name
Klinika Pediatrii, Hematologii i Onkologii
Contact Person Name
Piotr Księżniakiewicz
Contact Person Email
ksiezniakiewicz@gmail.com
Site Name
Uniwersytecki Szpital Dziecięcy w Krakowie
Department Name
Klinika Onkologii i Hematologii Dziecięcej
Contact Person Name
Katarzyna Pawińska-Wąsikowska
Site Name
Uniwersytecki Szpital Dziecięcy w Lublinie
Department Name
Klinika Hematologii, Onkologii i Transplantologii Dziecięcej
Contact Person Name
Alicja Mazur
Contact Person Email
hematologia@uszd.lublin.pl
Site Name
Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Department Name
Klinika Onkologii Hematologii i Transplantologii Pediatrycznej
Contact Person Name
Patrycja Marciniak-Stępak
Contact Person Email
pmarciniak@ump.edu.pl
Site Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Department Name
Klinika Transplantacji Szpiku, Onkologii i Hematologii Dziecięcej
Contact Person Name
Katarzyna Wilczyńska
Contact Person Email
katwilczyn@gmail.com
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Onkologii
Contact Person Name
Ewa Święszkowska
Contact Person Email
e.swieszkowska@ipczd.pl
Site Name
Medical University Of Gdansk
Department Name
Klinika Chirurgii i Urologii Dzieci i Młodzieży Gdańskiego Uniwersytetu Medycznego
Principal Investigator Name
Piotr Czauderna
Principal Investigator Email
piotr.czauderna@gumed.edu.pl
Contact Person Name
Piotr Czauderna
Contact Person Email
piotr.czauderna@gumed.edu.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Hematologii i Onkologii Dziecięcej
Contact Person Name
Agnieszka Książek
Contact Person Email
aksiazek@szpital.zabrze.pl
Site Name
Górnośląskie Centrum Zdrowia Dziecka
Department Name
Oddział Onkologii, Hematologii i Chemioterapii
Contact Person Name
Agnieszka Mizia-Malarz
Contact Person Email
amizia@gczd.katowice.pl
Site Name
Uniwersyteckie Centrum Kliniczne w Gdańsku
Department Name
Klinika Pediatrii, Hematologii i Onkologii
Contact Person Name
Joanna Stefanowicz

Sponsor

Primary sponsor

Full Name
Medical University Of Gdansk
Organisation Type
Educational Institution
Country Of Registered Address
Poland

Investigational products

Investigational Product Name
IRINOTECAN
Active Substance
IRINOTECAN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
100 mg
Investigational Product Name
OXALIPLATIN
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
200 mg
Investigational Product Name
Pedmark
Active Substance
SODIUM THIOSULFATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
1
Orphan Designation
Yes
Maximum Dose
25.6 g
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
200 mg
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
1000 mg
Investigational Product Name
FLUOROURACIL
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
1200 mg
Investigational Product Name
SORAFENIB
Active Substance
SORAFENIB TOSILATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Maximum Dose
400 mg
Investigational Product Name
DOXORUBICIN
Active Substance
DOXORUBICIN HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
60 mg
Investigational Product Name
ETOPOSIDE
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
400 mg
Investigational Product Name
VINORELBINE
Active Substance
VINORELBINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
2 mg
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
2
Maximum Dose
2000 mg

Related trials

Other published trials that may interest you.