Clinical trial • Phase I • Oncology
trichostatin A for Relapsed or refractory hematologic malignancies
Phase I trial of trichostatin A for Relapsed or refractory hematologic malignancies. None/Not specified-controlled, adaptive. 30 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory hematologic malignancies
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-11-2024
- First CTIS Authorization Date
- 23-12-2024
Trial design
None/Not specified-controlled, adaptive Phase I trial in Poland.
- Comparator
- None/Not specified
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 30
Eligibility
Recruits 30 Vulnerable population selected; no details on consent or assent handling provided..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 59
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 30
Poland
- Earliest CTIS Part Ii Submission Date
- 26-09-2024
- Latest Decision Or Authorization Date
- 18-03-2025
- Processing Time Days
- 173
- Number Of Sites
- 6
- Number Of Participants
- 30
Sites
- Site Name
- Pratia Hematologia Sp. z o.o.
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- sgrosicki@wp.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
- Department Name
- Oddział Onkologii Klinicznej
- Contact Person Name
- Piotr Centkowski
- Contact Person Email
- pcentek@wp.pl
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Klinika Hematologii
- Contact Person Name
- Kamil Wiśniewski
- Contact Person Email
- kwisniewski@ihit.waw.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Układu Chłonnego
- Contact Person Name
- Jan Walewski
- Contact Person Email
- jan.walewski@coi.pl
- Site Name
- Szpital Wojewodzki W Opolu Sp. z o.o.
- Department Name
- Oddział Kliniczny Hematologii, Onkologii Hematologicznej i Chorób Wewnętrznych
- Contact Person Name
- Dariusz Woszczyk
- Contact Person Email
- dariusz.s.woszczyk@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddział Kliniczny Hematologii
- Contact Person Name
- Agnieszka Giza
- Contact Person Email
- agnieszka.giza4@wp.pl
Sponsor
Primary sponsor
- Full Name
- Vanda Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Trichostatin A
- Active Substance
- trichostatin A
- Modality
- Small molecule
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)