Actively Recruiting
A Phase 1 Study to Assess STP938 as a Monotherapy in Adults With High Risk Essential Thrombocythaemia
Led by Step Pharma, SAS · Updated on 2026-01-28
20
Participants Needed
13
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if the drug STP938 works to treat adults with high risk essential thrombocythaemia (ET) who are resistant to, or intolerant of, hydroxycarbamide (also known as hydroxyurea) therapy. The trial will also learn about the safety of STP938. The main questions the trial aims to answer are: * Does STP938 control platelet counts * Does STP938 control platelet counts without inducing unwanted side effects Participants will: * Take STP938 every day for up to 12 months. * Visit the clinic once every week for the first month, then every 2 weeks for checkups and tests. * Complete a questionnaire about symptoms once a month.
CONDITIONS
Official Title
A Phase 1 Study to Assess STP938 as a Monotherapy in Adults With High Risk Essential Thrombocythaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of essential thrombocythaemia (ET) by WHO or BSH criteria
- Classified as high risk ET
- Raised platelet count greater than 600 x10^9/L requiring treatment
- Neutrophil count above 1.0 x10^9/L
- Intolerant or resistant to hydroxycarbamide treatment
- Adequate liver function
- Adequate blood clotting parameters
- ECOG performance status of 0 to 2
You will not qualify if you...
- Currently or recently receiving cytoreductive therapy for ET (washout periods apply)
- Received investigational agents for ET treatment within 4 weeks before enrollment or less than 5 half-lives since prior therapy
- Proven or suspected transformation to other blood disorders like polycythaemia vera, myelofibrosis, myelodysplasia, acute myeloid leukemia, or other myeloid neoplasms
- Known malabsorption syndrome or conditions impairing medication absorption (e.g., gastrectomy)
- Prior splenectomy
- Any uncontrolled illness
- Immunocompromised with increased risk of infections
- Active or chronic hepatitis B or active hepatitis C infection
- Pregnant or breastfeeding females, and women of childbearing potential or males unwilling to follow contraception requirements
- Known allergy to ingredients in the study drug
- Corrected QT interval over 470 msec on ECG at screening
AI-Screening
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Trial Site Locations
Total: 13 locations
1
CHU Brest
Brest, France
Actively Recruiting
2
Institut Paoli-Calmettes
Marseille, France
Actively Recruiting
3
CHU Nantes
Nantes, France
Actively Recruiting
4
CHU Nice
Nice, France
Actively Recruiting
5
CHU Nîmes
Nîmes, France
Actively Recruiting
6
Hôpital Saint-Louis
Paris, France
Actively Recruiting
7
Gustave Roussy
Villejuif, France
Actively Recruiting
8
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Not Yet Recruiting
9
University Hospital of Wales
Cardiff, United Kingdom
Actively Recruiting
10
Imperial College London / Hammersmith Hospital
London, United Kingdom
Actively Recruiting
11
Sarah Cannon Research Institute
London, United Kingdom
Actively Recruiting
12
Cancer and Haematology Centre, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
13
University of Southampton Hospital
Southampton, United Kingdom
Actively Recruiting
Research Team
C
Carol M MacLean, PhD
CONTACT
M
Maureen Higgins, PhD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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