Clinical trial • Phase I/II • Oncology|Gastroenterology
5-fluorouracil for Metastatic colorectal cancer
Phase I/II trial of 5-fluorouracil for Metastatic colorectal cancer. 33 participants.
Overview
- Trial Therapeutic Area
- Oncology|Gastroenterology
- Trial Disease
- Metastatic colorectal cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 05-07-2024
- First CTIS Authorization Date
- 12-08-2024
Trial design
Phase I/II trial across 6 sites in Italy.
- Target Sample Size
- 33
Eligibility
Recruits 33 Vulnerable population not selected (isVulnerablePopulationSelected=false); no specific vulnerable population consent or assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false); no specific vulnerable population consent or assent handling described in the record.
Recruitment
- Planned Sample Size
- 33
- Recruitment Window Months
- 60
- Consent Approach
- Not specified in the provided record; no details on informed consent/assent process, age-specific documents, or available languages.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 33
Italy
- Earliest CTIS Part Ii Submission Date
- 18-06-2024
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 552
- Number Of Sites
- 6
- Number Of Participants
- 33
Sites
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Oncologia
- Principal Investigator Name
- Silvio Ken Garattini
- Principal Investigator Email
- silvioken.garattini@asufc.sanita.fvg.it
- Contact Person Name
- Silvio Ken Garattini
- Contact Person Email
- silvioken.garattini@asufc.sanita.fvg.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Oncologia
- Principal Investigator Name
- Chiara Cremolini
- Principal Investigator Email
- chiaracremolini@gmail.com
- Contact Person Name
- Chiara Cremolini
- Contact Person Email
- chiaracremolini@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- department of medical and surgical sciences
- Principal Investigator Name
- Lisa Salvatore
- Principal Investigator Email
- lisa.salvatore@policlinicogemelli.it
- Contact Person Name
- Lisa Salvatore
- Contact Person Email
- lisa.salvatore@policlinicogemelli.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia Medica 1
- Principal Investigator Name
- Filippo Pietrantonio
- Principal Investigator Email
- filippo.pietrantonio@istitutotumori.mi.it
- Contact Person Name
- Filippo Pietrantonio
- Contact Person Email
- filippo.pietrantonio@istitutotumori.mi.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncologia medica
- Principal Investigator Name
- Rossana Intini
- Principal Investigator Email
- rossana.intini@iov.veneto.it
- Contact Person Name
- Rossana Intini
- Contact Person Email
- rossana.intini@iov.veneto.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Oncologia
- Principal Investigator Name
- Stefano Tamberi
- Principal Investigator Email
- stefano.tamberi@auslromagna.it
- Contact Person Name
- Stefano Tamberi
- Contact Person Email
- stefano.tamberi@auslromagna.it
Sponsor
Primary sponsor
- Full Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- 5-fluorouracil
- Active Substance
- 5-fluorouracil
- Modality
- Small molecule
- Investigational Product Name
- Leucovorin
- Active Substance
- Leucovorin
- Modality
- Small molecule
- Investigational Product Name
- Irinotecan
- Active Substance
- Irinotecan
- Modality
- Small molecule
- Investigational Product Name
- Temozolomide
- Active Substance
- Temozolomide
- Modality
- Small molecule
- Investigational Product Name
- Bevacizumab
- Active Substance
- Bevacizumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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