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
- Contact Person Email
- maximilien.roge@chb.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Radiotherapy
- Contact Person Name
- Adeline PETRE
- Contact Person Email
- adeline.petre@lyon.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Radiotherapy
- Contact Person Name
- Stéphane SUPIOT
- Contact Person Email
- stephane.supiot@ico.unicancer.fr
- 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
- Contact Person Email
- Nathalie.Mesgouez-Nebout@ico.unicancer.fr
- 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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