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
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

Sponsor

Primary sponsor

Full Name
Pharma Mar S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

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