Phase 2 Trial Evaluating STP938 for Adults with High Risk Essential Thrombocythaemia Intolerant or Resistant to Hydroxycarbamide

What this Trial Is About

Researchers are evaluating a drug called STP938 to treat adults with high risk essential thrombocythaemia ET who do not respond well or cannot tolerate hydroxycarbamide therapy. The study aims to find out if STP938 can control platelet counts effectively and safely in these patients. This phase 2 trial involves individuals who need treatment to lower platelet levels and have already tried hydroxycarbamide without success or due to side effects. Participants will take STP938 capsules daily in 28-day cycles for about 12 months, with the possibility to continue longer if the drug is effective and well tolerated. During the study, participants will have about 26 clinic visits, mostly twice per cycle, for checkups and tests. After treatment, there will be safety follow-up visits to monitor any adverse effects. Procedures include physical exams, ECGs, blood and urine tests, CTMRI scans, bone marrow biopsies, drug level tests, and gene testing. Participants will visit the clinic weekly for the first month, then every two weeks for ongoing monitoring. They will complete monthly symptom questionnaires to help track their condition. Researchers will measure clinical effectiveness and safety throughout the study, including how well STP938 controls platelet counts and its impact on disease-related complications. The total participation time is approximately one year, including treatment and follow-up periods.

A Phase 2 Study to Assess STP938 (Dencatistat) as a Monotherapy in Adults With High Risk Essential Thrombocythaemia - The VECTRA Trial