A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis
ConditionMyelofibrosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSumitomo Pharma America, Inc.
About this trial
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.
Eligibility criteria
Qualifiers
Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF/post-ET- MF and intermediate or high-risk primary or secondary MF
Previously treated with JAK inhibitor(s) and is intolerant, resistant, refractory or has lost response to the JAK inhibitor(s) or is ineligible to be treated with JAK inhibitor
Platelet count ≥ 25 x 10^9 /L, without assistance of growth factors or platelet transfusions
ANC ≥ 1 x 10^9/L without assistance of granulocyte growth factors
Disqualifiers
Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).
Major surgery within 4 weeks prior to Cycle 1 Day 1 and/or not recovered adequately from from surgery prior to first dose.
Splenic irradiation within 6 months prior to Screening or prior splenectomy.
Prior allogeneic stem cell transplant within the last 6 months.
Trial design
Treatments tested in this trial
- Nusivertib
- Ruxolitinib
- Momelotinib
Treatment groups
240 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov