Clinical trial • Phase I/II • Oncology|Other
niraparib for Ovarian cancer
Phase I/II trial of niraparib for Ovarian cancer. open-label. 73 participants.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Ovarian cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Small molecule
Key dates
- Initial CTIS Submission Date
- 15-02-2024
- First CTIS Authorization Date
- 31-05-2024
Trial design
open-label Phase I/II trial across 1 site in Italy.
- Open Label
- Yes
- Target Sample Size
- 73
Eligibility
Recruits 73 No vulnerable population selected..
- Vulnerable Population
- No vulnerable population selected.
Recruitment
- Planned Sample Size
- 73
- Recruitment Window Months
- 59
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 73
Italy
- Earliest CTIS Part Ii Submission Date
- 22-05-2024
- Latest Decision Or Authorization Date
- 11-12-2025
- Processing Time Days
- 568
- Number Of Sites
- 1
- Number Of Participants
- 73
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Ginecologia Oncologica
- Principal Investigator Name
- Francesco Raspegliesi
- Principal Investigator Email
- francesco.raspagliesi@istitutotumori.mi.it
- Contact Person Name
- Francesco Raspegliesi
- Contact Person Email
- francesco.raspagliesi@istitutotumori.mi.it
Sponsor
Primary sponsor
- Full Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- niraparib
- Active Substance
- niraparib
- Modality
- Small molecule
- Investigational Product Name
- abemaciclib
- Active Substance
- abemaciclib
- Modality
- Small molecule
- Combination Treatment
- Yes
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