Clinical trial • Phase I • Oncology
BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
Phase I trial of BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 01-11-2023
- First CTIS Authorization Date
- 26-02-2024
Trial design
None/Not specified-controlled Phase I trial across 8 sites in France.
- Comparator
- None/Not specified
- Target Sample Size
- 380
Eligibility
Recruits 380 Vulnerable population selected; no details on consent or assent provided..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent provided.
Recruitment
- Planned Sample Size
- 380
- Recruitment Window Months
- 57
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 380
France
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 14-08-2025
- Processing Time Days
- 576
- Number Of Sites
- 8
- Number Of Participants
- 91
Sites
- Site Name
- Institut Curie
- Department Name
- Medical Oncology
- Contact Person Name
- Marie-Paule SABLIN
- Contact Person Email
- xxx@xxx.xx
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP
- Contact Person Name
- Kaïssa OUALI
- Contact Person Email
- xxx@xxx.xx
- Site Name
- Centre Francois Baclesse
- Department Name
- Medical Oncology
- Contact Person Name
- Georges EMILE
- Contact Person Email
- xxx@xxx.xx
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Contact Person Name
- Maxime BRUNET
- Contact Person Email
- xxx@xxx.xx
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical oncology
- Contact Person Name
- Mario Campone
- Contact Person Email
- xxx@xxx.xx
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Contact Person Name
- Arthur GERAUD-CREMIEUX
- Contact Person Email
- xxx@xxx.xx
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology
- Contact Person Name
- Audrey MAILLIEZ
- Contact Person Email
- xxx@xxx.xx
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- Medical oncology
- Contact Person Name
- Antoine Deleuze
- Contact Person Email
- xxx@xxx.xx
Sponsor
Primary sponsor
- Full Name
- BeOne Medicines AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- BGB-43395
- Active Substance
- BGB-43395
- Modality
- Small molecule
- Combination Treatment
- Yes
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