Clinical trial • Phase I/II • Oncology
Anastrozole for Endometrial adenocarcinoma | Advanced/metastatic endometrial cancer | Hormone receptor-positive endometrial cancer
Phase I/II trial of Anastrozole for Endometrial adenocarcinoma | Advanced/metastatic endometrial cancer | Hormone receptor-positive endometrial cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Endometrial adenocarcinoma | Advanced/metastatic endometrial cancer | Hormone receptor-positive endometrial cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-10-2024
- First CTIS Authorization Date
- 27-11-2024
Trial design
Randomised, open-label, anastrozole alone (dose/schedule not specified)-controlled Phase I/II trial across 4 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Anastrozole alone (dose/schedule not specified)
- Target Sample Size
- 72
Eligibility
Recruits 72 Vulnerable population not selected; no special consent or assent handling described in the available record..
- Vulnerable Population
- Vulnerable population not selected; no special consent or assent handling described in the available record.
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 128
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 72
France
- Earliest CTIS Part Ii Submission Date
- 21-11-2024
- Latest Decision Or Authorization Date
- 27-11-2024
- Processing Time Days
- 6
- Number Of Sites
- 4
- Number Of Participants
- 72
Sites
- Site Name
- CHU Besancon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laura MANSI
- Principal Investigator Email
- lmansi@chu-besancon.fr
- Contact Person Name
- Laura MANSI
- Contact Person Email
- lmansi@chu-besancon.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean-Sébastien FRENEL
- Principal Investigator Email
- jean-sebastien.frenel@ico.unicancer.fr
- Contact Person Name
- Jean-Sébastien FRENEL
- Contact Person Email
- jean-sebastien.frenel@ico.unicancer.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology
- Principal Investigator Name
- Cyril ABDEDDAIM
- Principal Investigator Email
- c-abdeddaim@o-lambret.fr
- Contact Person Name
- Cyril ABDEDDAIM
- Contact Person Email
- c-abdeddaim@o-lambret.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Anne FLOQUET
- Principal Investigator Email
- a.floquet@bordeaux.unicancer.fr
- Contact Person Name
- Anne FLOQUET
- Contact Person Email
- a.floquet@bordeaux.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Centre Leon Berard
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- AZD2014
- Modality
- Small molecule
- Investigational Product Name
- Anastrozole
- Active Substance
- Anastrozole
- Modality
- Small molecule
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)