Clinical trial • Phase I • Oncology|Neurology

Alpelisib for Meningioma

Phase I trial of Alpelisib for Meningioma. 35 participants.

Overview

Trial Therapeutic Area
Oncology|Neurology
Trial Disease
Meningioma
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-07-2024
First CTIS Authorization Date
14-08-2024

Trial design

Phase I trial across 4 sites in France.

Target Sample Size
35

Eligibility

Recruits 35 Vulnerable population not selected; no consent or assent information provided..

Vulnerable Population
Vulnerable population not selected; no consent or assent information provided.

Recruitment

Planned Sample Size
35
Recruitment Window Months
88

Geography

Total Number Of Sites
4
Total Number Of Participants
35

France

Earliest CTIS Part Ii Submission Date
25-07-2024
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
574
Number Of Sites
4
Number Of Participants
35

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurologie
Contact Person Name
Marc Sanson
Contact Person Email
marc.sanson@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Neurochirurgie
Contact Person Name
Thomas GRAILLON
Contact Person Email
thomas.graillon@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie médicale
Contact Person Name
Charlotte Bronnimann
Site Name
Pellegrin Hospital
Department Name
Neurochirurgie
Contact Person Name
Charlotte Bronnimann

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Regional De Marseille
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Alpelisib
Active Substance
Alpelisib
Modality
Small molecule
Investigational Product Name
Trametinib
Active Substance
Trametinib
Modality
Small molecule
Combination Treatment
Yes

Related trials

Other published trials that may interest you.