Clinical trial • Phase I/II • Oncology

Metformin for Local recurrence of prostate cancer (previously irradiated prostate bed)

Phase I/II trial of Metformin for Local recurrence of prostate cancer (previously irradiated prostate bed). None/Not specified-controlled. 44 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Local recurrence of prostate cancer (previously irradiated prostate bed)
Trial Stage
Phase I/II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-01-2024
First CTIS Authorization Date
09-04-2024

Trial design

None/Not specified-controlled Phase I/II trial across 11 sites in France.

Comparator
None/Not specified
Target Sample Size
44

Eligibility

Recruits 44 Vulnerable population not selected. No details on consent or assent handling available..

Vulnerable Population
Vulnerable population not selected. No details on consent or assent handling available.

Recruitment

Planned Sample Size
44
Recruitment Window Months
133

Geography

Total Number Of Sites
11
Total Number Of Participants
44

France

Earliest CTIS Part Ii Submission Date
05-02-2024
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
630
Number Of Sites
11
Number Of Participants
44

Sites

Site Name
Pole Sante Leonard De Vinci
Department Name
Radiotherapy
Contact Person Name
Thomas BOISSERIE
Contact Person Email
t.boisserie@cort37.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Radiotherapy
Contact Person Name
Ulrike SCHICK
Contact Person Email
ulrike.schick@chu-brest.fr
Site Name
Centre Henri Becquerel
Department Name
Radiotherapy
Contact Person Name
Maximilien ROGE
Site Name
Centre Leon Berard
Department Name
Radiotherapy
Contact Person Name
Adeline PETRE
Site Name
Institut De Cancerologie De L Ouest
Department Name
Radiotherapy
Contact Person Name
Stéphane SUPIOT
Site Name
Centr Georges Francois Leclerc
Department Name
Radiotherapy
Contact Person Name
Magali QUIVRIN
Contact Person Email
mquivrin@cgfl.fr
Site Name
Centre Oscar Lambret
Department Name
Radiotherapy
Contact Person Name
David PASQUIER
Contact Person Email
d-pasquier@o-lambret.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Radiotherapy
Contact Person Name
Nathalie MESGOUEZ-NEBOUT
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Radiotherapy
Contact Person Name
Astrid THOMIN
Contact Person Email
astrid.thomin@univ-tours.fr
Site Name
Clinique Victor Hugo
Department Name
Radiotherapy
Contact Person Name
Amandine RUFFIER-LOUBIERE
Contact Person Email
essaisruffier@ilcgroupe.fr
Site Name
Centre Regional Lutte Contre Le Cancer
Department Name
Radiotherapy
Contact Person Name
Jean-Baptiste CLAVIER
Contact Person Email
jb.clavier@icans.eu

Sponsor

Primary sponsor

Full Name
Institut De Cancerologie De L Ouest
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Metformine
Active Substance
Metformin
Modality
Small molecule
Combination Treatment
Yes

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