A Phase 2 Study to Assess STP938 (Dencatistat) as a Monotherapy in Adults With High Risk Essential Thrombocythaemia - The VECTRA Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
STP938: At enrolment all patients will be assigned to a single dose level of STP938 for 4 weeks. After 4 weeks the dose level may be adjusted as needed by the Investigator.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Clinical Efficacy — Through study completion, an average of 12 months
Complete and partial response rates per European LeukemiaNet criteria - Safety and Tolerability — Through study completion, an average of 12 months
Toxicity profile based on National Cancer Institute Common Terminology Criteria for Adverse Events
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital de la Milétrie, CHU | Poitiers | New Aquitaine | Not Yet Recruiting |
| CHU Brest | Brest | France | Recruiting |
| Institut Paoli-Calmettes | Marseille | France | Recruiting |
| CHU Nantes | Nantes | France | Recruiting |
| CHU Nice | Nice | France | Recruiting |
| CHU Nîmes | Nîmes | France | Recruiting |
| Hôpital Saint-Louis | Paris | France | Recruiting |
| Gustave Roussy | Villejuif | France | Recruiting |
| Royal Hallamshire Hospital | Sheffield | South Yorkshire | Recruiting |
| University Hospital of Wales | Cardiff | United Kingdom | Recruiting |
| Imperial College London / Hammersmith Hospital | London | United Kingdom | Recruiting |
| Sarah Cannon Research Institute | London | United Kingdom | Recruiting |
| Cancer and Haematology Centre, Churchill Hospital | Oxford | United Kingdom | Recruiting |
| University of Southampton Hospital | Southampton | United Kingdom | Recruiting |
More Step Pharma, SAS trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06786234 on ClinicalTrials.gov ↗ ← All trials in France