Study of the Safety of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 in Patients With Myelofibrosis

Official Title

A Phase Ib, Multi-centre, Open-label, Dose-escalation Study of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 Administered Orally in Patients With Myelofibrosis

Summary:

This is a phase Ib study with the primary purpose is to estimate the MTD and/or RDE for the triple combination of PIM447, formerly LGH447, plus ruxolitinib and LEE011 as well as for the doublets, PIM447 plus ruxolitinib, and LEE011 plus ruxolitinib, in patients with myelofibrosis (MF). Each regimen will be assessed for safety, tolerability, pharmacokinetics (PK) and pharmacodynamic effects, and preliminary anti-myelofibrosis activity, including changes in spleen volume, JAK2V617F allele burden, and hematologic response.

Trial Description

Primary Outcome Measures:

  • Incidence of dose limiting toxicities during the first cycle of study treatment
Secondary Outcome Measures:
  • Number of participants with adverse events/serious adverse events
  • Proportion of patients achieving ≥ 35% reduction in spleen volume by magnetic resonance imaging (MRI) at Week 24
  • Changes in ratio of mutant to wild type JAK2 alleles (i.e. allele burden)
  • Change in platelets, neutrophils, and hemoglobin
  • Change in bone marrow fibrosis and histomorphology
  • Determine single and multiple dose pharmacokinetics (PK) profiles
  • Change in spleen volume as measured by MRI from baseline 

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society