Clinical trial • Phase I/II • Oncology

Olaparib for Glioblastoma

Phase I/II trial of Olaparib for Glioblastoma. 91 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Glioblastoma
Trial Stage
Phase I/II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-09-2024
First CTIS Authorization Date
08-11-2024

Trial design

Phase I/II trial across 13 sites in France.

Target Sample Size
91
Trial Duration For Participant
365

Eligibility

Recruits 91 No vulnerable populations selected..

Vulnerable Population
No vulnerable populations selected.

Recruitment

Planned Sample Size
91
Recruitment Window Months
12

Geography

Total Number Of Sites
13
Total Number Of Participants
91

France

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
581
Number Of Sites
13
Number Of Participants
91

Sites

Site Name
Centre Leon Berard
Department Name
Radiotherapy
Contact Person Name
Marie-Pierre- SUNYACH
Site Name
Centre Francois Baclesse
Department Name
Radiotherapie
Contact Person Name
Dinu STEFAN
Contact Person Email
d.stefan@baclesse.unicancer.fr
Site Name
Groupe Hospitalier Du Havre
Department Name
Oncology department
Contact Person Name
Violette ALLOUCHERY
Site Name
Centre Henri Becquerel
Department Name
Centre Onclogie Medicale
Contact Person Name
Cristina ALEXANDRU
Site Name
Groupe Hospitalier Bretagne Sud
Department Name
Oncology
Contact Person Name
Edwina GIRARD
Contact Person Email
e.girard@ghbs.bzh
Site Name
Institut Curie
Department Name
Radiotherapy department
Contact Person Name
Hamid MAMMAR
Contact Person Email
hamid.mammar@curie.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology department
Contact Person Name
Pierre KUBICEK
Site Name
Oncopole Claudius Regaud
Department Name
Radiotherapy department
Contact Person Name
Elisabeth MOYAL
Site Name
CHU De Bordeaux
Department Name
Service Oncologie Médicale
Contact Person Name
Charlotte BRONNIMANN
Site Name
Institut De Cancerologie De L Ouest
Department Name
Service Oncologie-Radiothérapie
Contact Person Name
Carole GOURMELON
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Service Oncologie-Radiothérapie
Contact Person Name
Julian JACOB
Contact Person Email
julian.jacob@aphp.fr
Site Name
Centre De Radiotherapie Guillaume Le Conquerant
Department Name
Radiotherapie
Contact Person Name
Paul LESUEUR
Contact Person Email
p.lesueur@cglc.fr
Site Name
CHU De Medecine Interne
Department Name
Service Oncologie Médicale
Contact Person Name
Mathieu BOONE
Contact Person Email
boone.mathieu@chu-amiens.fr

Sponsor

Primary sponsor

Full Name
Centre Francois Baclesse
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Olaparib
Active Substance
Olaparib
Modality
Small molecule
Investigational Product Name
Temozolomide
Active Substance
Temozolomide
Modality
Small molecule
Combination Treatment
Yes

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