Clinical trial • Phase I • Other
MEK (1/2) inhibitor for Solid Tumors
Phase I trial of MEK (1/2) inhibitor for Solid Tumors. open-label. 24 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Solid Tumors
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-02-2024
- First CTIS Authorization Date
- 24-06-2024
Trial design
open-label Phase I trial across 3 sites in Bulgaria, Romania.
- Open Label
- Yes
- Target Sample Size
- 24
Eligibility
Recruits 24 No vulnerable populations selected; no specific consent or assent handling is described in the provided records..
- Vulnerable Population
- No vulnerable populations selected; no specific consent or assent handling is described in the provided records.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 28
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 24
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 561
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Multiprofile Hospital for Active Treatment Sveta Sofia
- Department Name
- Oncology
- Principal Investigator Name
- Marchela Koleva
- Principal Investigator Email
- marchela.koleva.ext@arensia-em.com
- Contact Person Name
- Marchela Koleva
- Contact Person Email
- marchela.koleva.ext@arensia-em.com
Romania
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 21-10-2024
- Processing Time Days
- 208
- Number Of Sites
- 2
- Number Of Participants
- 16
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Radiotherapy
- Principal Investigator Name
- Tudor-Eliade Ciuleanu
- Principal Investigator Email
- tudor.ciuleanu.ext@arensia-em.com
- Contact Person Name
- Tudor-Eliade Ciuleanu
- Contact Person Email
- tudor.ciuleanu.ext@arensia-em.com
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- Medical Oncology II, Radiotherapy I
- Principal Investigator Name
- Nicoleta Laurentia Gales
- Principal Investigator Email
- laurentia.gales.ext@arensia-em.com
- Contact Person Name
- Nicoleta Laurentia Gales
- Contact Person Email
- laurentia.gales.ext@arensia-em.com
Sponsor
Primary sponsor
- Full Name
- Pasithea Therapeutics Corp.
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- PAS-004
- Active Substance
- MEK (1/2) inhibitor
- Modality
- Small molecule
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