Clinical trial • Phase II • Oncology

BLEOMYCIN SULFATE for Locally advanced pancreatic cancer | Pancreatic carcinoma

Phase II trial of BLEOMYCIN SULFATE for Locally advanced pancreatic cancer | Pancreatic carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced pancreatic cancer | Pancreatic carcinoma
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
05-11-2024
First CTIS Authorization Date
02-12-2024

Trial design

Conventional systemic treatment (FOLFOXIRI); dose/schedule not specified-controlled Phase II trial across 5 sites in Italy.

Comparator
Conventional systemic treatment (FOLFOXIRI); dose/schedule not specified
Target Sample Size
90

Eligibility

Recruits 90 Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must have the ability to sign a specific informed consent (inclusion criterion). Subject information and informed consent forms are listed in the documents. Minors are excluded (Age ≥ 18 and exclusion 'Age less than 18 years')..

Pregnancy Exclusion
Pregnancy or lactation
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Participants must have the ability to sign a specific informed consent (inclusion criterion). Subject information and informed consent forms are listed in the documents. Minors are excluded (Age ≥ 18 and exclusion 'Age less than 18 years').

Inclusion criteria

  • {"criterion_text":"- Age≥ 18 years\n- Good mental health conditions\n- Ability to sign a specific informed consent in order to be enrolled to the study.\n- Life expectancy in line with the follow-up indicated by the study\n- Diagnosis of exocrine pancreatic cancer with histological confirmation\n- Preoperative Staging of locally advanced pancreatic cancer disease: stage III\n- The subject is not eligible for the \"gold-standard\" treatment of surgical pancreatectomy and is eligible for a conventional systemic treatment (FOLFOXIRI)"}

Exclusion criteria

  • {"criterion_text":"- Age less than 18 years\n- Absolute contraindication to surgery\n- Visceral, bone or diffuse metastases\n- Presence of extrahepatic spread of the disease\n- Clinically significant ascites\n- Any serious and uncontrolled systemic illness\n- Acute lung infection\n- Symptoms of poor lung function by clinical examination and Pulmonary function tests (PFT)\n- Non correctable severe coagulation disorders\n- Contraindications at the assumption of bleomycin (Bleoprim)\n- Previous allergic reactions to bleomycin\n- Previous cumulative dose of 250 mg/m2 of bleomycin exceeded\n- Pregnancy or lactation"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Increase in the objective response rate of the treated lesion in the treatment arm compared to the control arm","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Evaluate the effect of ECT on disease progression-free time and survival.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Evaluate the impact of ECT on quality of life, with particular attention to its effect on pain","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Assess the toxicity associated with Electrochemotherapy treatment.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Evaluate the conversion rate of the disease from locally advanced to resectable between the two arms.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
90
Recruitment Window Months
72
Consent Approach
Participants must sign a specific informed consent (document: 'Consenso informato versione 1_1 del 18 Mar 2020' and 'Consenso al trattamento dei dati versione 1_2 del 6 Nov 2023' are listed). No assent procedures are indicated; minors are excluded. Languages of consent forms are not specified in the record.

Geography

Total Number Of Sites
5
Total Number Of Participants
90

Italy

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
48
Number Of Sites
5
Number Of Participants
90

Sites

Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Divisione di Chirurgia Oncologica dell'Apparato Digerente
Contact Person Name
Gennaro Galizia
Contact Person Email
gennaro.galizia@unicampania.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Division of Abdominal Surgical Oncology, Hepato-Biliary Unit
Contact Person Name
Francesco Izzo
Contact Person Email
f.izzo@istitutotumori.na.it
Site Name
A. O. U. Policlinico Sant'Orsola Malpighi
Department Name
Dipartimento di Scienze Mediche e Chirurgiche
Contact Person Name
Riccardo Casadei
Contact Person Email
riccardo.casadei@unibo.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Dipartimento di Chirurgia
Contact Person Name
Giuseppe Navarra
Contact Person Email
gnavarra@unime.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Dipartimento di Chirurgia
Contact Person Name
Franco De Cian
Contact Person Email
decian@unige.it

Sponsor

Primary sponsor

Full Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
BLEOPRIM 15 mg polvere per soluzione iniettabile
Active Substance
BLEOMYCIN SULFATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number 022395026)
Maximum Dose
15000 billion organisms billion organisms
Investigational Product Name
Fluorouracil 50 mg/ml Solution for Injection or Infusion
Active Substance
FLUOROURACIL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number PL 20075/0078)
Maximum Dose
3200 mg/m2
Investigational Product Name
LEDERFOLIN 25 mg Polvere per soluzione iniettabile per uso endovenoso
Active Substance
CALCIUM LEVOFOLINATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number 024659120)
Maximum Dose
200 mg/m2
Investigational Product Name
CAMPTO 20 mg/mL concentrate for solution for infusion
Active Substance
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number PL 00057/0627)
Maximum Dose
165 mg/m2
Investigational Product Name
Oxaliplatin 5 mg/ml Concentrate for Solution for infusion
Active Substance
OXALIPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation number PL 56284/0009)
Maximum Dose
85 mg/m2
Combination Treatment
Yes

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