Clinical trial • Phase III • Oncology

Clinical trial in IDH1-mutated malignancies | Solid tumour | Hematological malignancy

Phase III trial for IDH1-mutated malignancies | Solid tumour | Hematological malignancy. 25 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
IDH1-mutated malignancies | Solid tumour | Hematological malignancy
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
05-08-2025
First CTIS Authorization Date
24-11-2025

Trial design

Phase III trial across 9 sites in Czechia, Spain.

Biomarker Stratified
True, biomarker: IDH1 mutation; strata: not specified
Target Sample Size
25

Eligibility

Recruits 25 Vulnerable population selected; no further details provided in source regarding consent or assent handling..

Vulnerable Population
Vulnerable population selected; no further details provided in source regarding consent or assent handling.

Recruitment

Planned Sample Size
25
Recruitment Window Months
36

Geography

Total Number Of Sites
9
Total Number Of Participants
25

Czechia

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
106
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
I. Interni klinika – klinika hematologie
Principal Investigator Name
Anna Jonasova
Principal Investigator Email
anna.jonasova@vfn.cz
Contact Person Name
Anna Jonasova
Contact Person Email
anna.jonasova@vfn.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika hematoonkologie FNO a LF OU
Principal Investigator Name
Barbora Dluhosova
Principal Investigator Email
barbora.dluhosova@fno.cz
Contact Person Name
Barbora Dluhosova
Contact Person Email
barbora.dluhosova@fno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologicke oddeleni
Principal Investigator Name
Katerina Kopeckova
Principal Investigator Email
Katerina.kopeckova@fnmotol.cz
Contact Person Name
Katerina Kopeckova
Contact Person Email
Katerina.kopeckova@fnmotol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interni hematologicka a onkologicka klinika
Principal Investigator Name
Jiri Mayer
Principal Investigator Email
mayer.jiri@fnbrno.cz
Contact Person Name
Jiri Mayer
Contact Person Email
mayer.jiri@fnbrno.cz

Spain

Earliest CTIS Part Ii Submission Date
19-08-2025
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
209
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Manuel Pedregal Trujillo
Principal Investigator Email
manuel.pedregal@startmadrid.com
Contact Person Name
Manuel Pedregal Trujillo
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Principal Investigator Name
Irene Moreno Candilejo
Principal Investigator Email
irene.moreno@startmadrid.com
Contact Person Name
Irene Moreno Candilejo
Contact Person Email
irene.moreno@startmadrid.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Jorge Adeva Alfonso
Principal Investigator Email
jorge.adeva@salud.madrid.org
Contact Person Name
Jorge Adeva Alfonso
Contact Person Email
jorge.adeva@salud.madrid.org
Site Name
Hospital Hm Nou Delfos
Department Name
Oncology
Principal Investigator Name
Tatiana Hernandez Guerrero
Principal Investigator Email
Tatiana.hernandez@start-barcelona.com
Contact Person Name
Tatiana Hernandez Guerrero
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Maria Julia Lostes Bardaji
Principal Investigator Email
jlostes@vhio.net
Contact Person Name
Maria Julia Lostes Bardaji
Contact Person Email
jlostes@vhio.net

Sponsor

Primary sponsor

Full Name
Institut De Recherches Internationales Servier IRIS
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

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