Oral TP-3654 for Myelofibrosis
Trial Summary
The trial does not specify that you must stop all current medications, but certain treatments like systemic antineoplastic therapy or experimental therapies must be stopped at least 2 weeks or 5 half-lives before starting the trial. If you are on a JAK inhibitor like ruxolitinib, you may need to taper off over at least 1 week. Hydroxyurea or anagrelide can be taken up to 24 hours before starting the trial.
TP-3654, also known as Nuvisertib, is unique because it is an oral treatment for myelofibrosis, which may offer a different mechanism of action compared to existing JAK2 inhibitors like fedratinib and ruxolitinib. While the specific details of TP-3654's action in myelofibrosis are not provided, its development suggests it may target pathways not addressed by current standard treatments.
12345Eligibility Criteria
This trial is for adults with primary or secondary myelofibrosis, a type of bone marrow cancer. They must have tried and failed JAK inhibitor treatment or be ineligible for it. Participants need to have certain blood counts, organ function within specific limits, and a life expectancy of at least 3 months. They can't join if they've had recent surgeries or other treatments that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nuvisertib (TP-3654) in various combinations depending on the arm, with dose-escalation to assess safety, tolerability, pharmacokinetics, and pharmacodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of spleen volume reduction and symptom score improvement
Long-term follow-up
Participants are monitored for overall survival and long-term safety outcomes