Clinical trial • Phase I • Oncology
Clinical trial in Advanced solid tumors
Phase I trial for Advanced solid tumors. 105 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 22-11-2024
- First CTIS Authorization Date
- 08-03-2025
Trial design
Phase I trial across 3 sites in Spain.
- Target Sample Size
- 105
Eligibility
Recruits 105 Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on vulnerable population definition, consent or assent procedures provided in the available record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on vulnerable population definition, consent or assent procedures provided in the available record.
Recruitment
- Planned Sample Size
- 105
- Recruitment Window Months
- 36
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 105
Spain
- Earliest CTIS Part Ii Submission Date
- 19-02-2025
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 404
- Number Of Sites
- 3
- Number Of Participants
- 105
Sites
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- NEXT Madrid Phase I trials
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Ana Gil
- Principal Investigator Email
- ana.gil.torralvo.sspa@juntadeandalucia.es
- Contact Person Name
- Ana Gil
- Contact Person Email
- ana.gil.torralvo.sspa@juntadeandalucia.es
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- START Barcelona- HM Nou Delfos
- Principal Investigator Name
- Roberto Martin
- Principal Investigator Email
- roberto.martin@startresearch.com
- Contact Person Name
- Roberto Martin
- Contact Person Email
- roberto.martin@startresearch.com
Sponsor
Primary sponsor
- Full Name
- Pharma Mar S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
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