Clinical trial • Phase I • Oncology
MK-8294 for Breast cancer|Cervical squamous cell carcinoma|Endometrial carcinoma|Oesophageal (esophageal) squamous cell carcinoma|Squamous cell carcinoma of head and neck|Bladder cancer
Phase I trial of MK-8294 for Breast cancer|Cervical squamous cell carcinoma|Endometrial carcinoma|Oesophageal (esophageal) squamous cell carcinoma|Squamou…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Breast cancer|Cervical squamous cell carcinoma|Endometrial carcinoma|Oesophageal (esophageal) squamous cell carcinoma|Squamous cell carcinoma of head and neck|Bladder cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 13-02-2025
- First CTIS Authorization Date
- 11-04-2025
Trial design
open-label, none/not specified-controlled Phase I trial across 2 sites in Netherlands.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 33
Eligibility
Recruits 33 Vulnerable population not selected; no specific consent or assent handling described in the record..
- Vulnerable Population
- Vulnerable population not selected; no specific consent or assent handling described in the record.
Recruitment
- Planned Sample Size
- 33
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 33
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-04-2025
- Latest Decision Or Authorization Date
- 23-07-2025
- Processing Time Days
- 111
- Number Of Sites
- 2
- Number Of Participants
- 14
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Medical Oncology
- Contact Person Name
- Carla Herpen, van
- Contact Person Email
- Studies.onco@radboudumc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Clinical Research Unit
- Contact Person Name
- Tim Schutte
- Contact Person Email
- fase1@nki.nl
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- MK-8294
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