Clinical trial • Phase III • Oncology
OATD-02 for Advanced solid tumours | Colorectal cancer | Ovarian cancer | Pancreatic cancer | Renal cell carcinoma
Phase III trial of OATD-02 for Advanced solid tumours | Colorectal cancer | Ovarian cancer | Pancreatic cancer | Renal cell carcinoma. open-label.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumours | Colorectal cancer | Ovarian cancer | Pancreatic cancer | Renal cell carcinoma
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 10-04-2024
- First CTIS Authorization Date
- 06-05-2024
Trial design
open-label Phase III trial across 3 sites in Poland.
- Open Label
- Yes
- Target Sample Size
- 30
Eligibility
Recruits 30 Vulnerable population selected; no details provided in the record about consent, assent, or handling of vulnerable participants..
- Vulnerable Population
- Vulnerable population selected; no details provided in the record about consent, assent, or handling of vulnerable participants.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 55
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 30
Poland
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 23-09-2025
- Processing Time Days
- 552
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Europejskie Centrum Zdrowia Otwock Sp. z o.o.
- Department Name
- Klinika Onkologii
- Contact Person Name
- Cezary Szczylik
- Contact Person Email
- cezary.szczylik@ecz-otwock.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- zurawskib@co.bydgoszcz.pl
- Site Name
- Lux Med Onkologia Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej/Chemioterapii
- Contact Person Name
- Maciej Studziński
- Contact Person Email
- maciejstudzinski@pm.me
Sponsor
Primary sponsor
- Full Name
- Molecure S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- OATD-02
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