NCT06327100

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF.

Detailed 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 and in combination with stable dose of ruxolitinib To determine time to response and response duration. To assess changes in symptom burden as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MFSAF v4.0). To assess changes in bone marrow fibrosis grade. To assess the pharmacokinetics (PK) of tasquinimod in blood to determine whether the systemic exposure of tasquinimod, when administered alone or in combination with ruxolitinib in patients with MF. To assess correlation of response / resistance to tasquinimod with baseline genetic markers (cytogenetic alterations and mutations determined by NextGen sequencing of an 81-gene myeloid panel).

Conditions

• Primary Myelofibrosis
• Post-polycythemia Vera Myelofibrosis
• Post-Essential Thrombocytosis Myelofibrosis

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Given by PO
DRUG	Tasquinimod	Given by PO

Timeline

• Start date: 2024-08-01
• Primary completion: 2029-05-01
• Completion: 2031-05-01
• First posted: 2024-03-25
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study