Clinical trial • Phase I • Oncology
Clinical trial in Advanced or metastatic carcinoma
Phase I trial for Advanced or metastatic carcinoma. 38 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced or metastatic carcinoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 25-01-2024
- First CTIS Authorization Date
- 05-03-2024
Trial design
Phase I trial across 7 sites in Germany, Italy.
- Target Sample Size
- 38
Eligibility
Recruits 38 No vulnerable population selected..
- Vulnerable Population
- No vulnerable population selected.
Recruitment
- Planned Sample Size
- 38
- Recruitment Window Months
- 74
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 56
Germany
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 19-11-2025
- Processing Time Days
- 645
- Number Of Sites
- 4
- Number Of Participants
- 28
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Medicine II
- Contact Person Name
- Franziska Westendorf
- Contact Person Email
- f.modemann@uke.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Dermatology and National Center for Tumor Diseases (NCT)
- Contact Person Name
- Jessica C. Hassel
- Contact Person Email
- jessica.hassel@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Innere Medizin VIII
- Contact Person Name
- Ulrich M. Lauer
- Contact Person Email
- ulrich.lauer@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Dermatology, Venerology and Allergology
- Contact Person Name
- Jan Christoph Simon
- Contact Person Email
- jan.simon@medizin.uni-leipzig.de
Italy
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 806
- Number Of Sites
- 3
- Number Of Participants
- 28
Sites
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Immunoterapia clinica dei tumori e terapie innovative
- Contact Person Name
- Massimo Di Nicola
- Contact Person Email
- massimo.dinicola@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Oncologia
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
Sponsor
Primary sponsor
- Full Name
- Philogen S.p.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Italy
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