Clinical trial • Phase I • Oncology
Clinical trial in Malignant neoplasm (solid tumors)
Phase I trial for Malignant neoplasm (solid tumors). 82 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Malignant neoplasm (solid tumors)
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 22-10-2024
- First CTIS Authorization Date
- 24-02-2025
Trial design
Phase I trial across 6 sites in Spain, Poland.
- Target Sample Size
- 82
Recruitment
- Planned Sample Size
- 82
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 30
Spain
- Earliest CTIS Part Ii Submission Date
- 27-01-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 406
- Number Of Sites
- 4
- Number Of Participants
- 22
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- Alejandro Falcon Gonzalez
- Contact Person Email
- alejndro.falcon.sspa@juntadeandalucia.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Contact Person Name
- Jose Carlos Ruffinelli Rodriguez
- Contact Person Email
- jruffinelli@iconcologia.net
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
Poland
- Earliest CTIS Part Ii Submission Date
- 24-01-2025
- Latest Decision Or Authorization Date
- 07-03-2026
- Processing Time Days
- 407
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oddział Badań Wczesnych Faz
- Contact Person Name
- Iwona Ługowska
- Contact Person Email
- obwf@nio.gov.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- obkwf@uck.gda.pl
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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