Open Label Phase 1/2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF)
M.D. Anderson Cancer Center
Summary
To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF.
Description
Primary Objectives To determine anti-tumor activity of tasquinimod in patients with PMF, post-PV MF, and post-ET MF in a monotherapy and in combination with stable dose of ruxolitinib based on the measurement of the objective response rate (ORR) which is defined as the proportion of patients with CR (complete remission), PR (partial remission), or CI (clinical improvement) after six cycles of treatment, according to the International Working Group (IWG) consensus criteria. Secondary Objectives To determine safety of tasquinimod in patients with PMF, post-PV MF, and post-ET MF in a monotherapy…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants eligible for inclusion in this study have to meet the following criteria: Myelofibrosis MF Monotherapy: Participants who are not candidates for, intolerant of, or relapsed/refractory to approved JAKi (ruxolitinib and / or fedratinib / pacritinib) or when further benefit from therapy is not anticipated per investigator. Participants not eligible for JAKi therapy irrespectively of previous treatments. Prior JAKi therapy is not required. Myelofibrosis Ruxolitinib Combination MF participants treated with Ruxolitinib for at least 3 months on a stable, uninterrup…
Interventions
- DrugRuxolitinib
Given by PO
- DrugTasquinimod
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas