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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02370706
Phase
PHASE1
Status
Completed

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PIM447 — DRUG
    pan-pim inhibitor
  • Ruxolitinib — DRUG
    JAK1/JAK2 inhibitor
  • LEE011 — DRUG
    CDK4/6 inhibitor

Study Details

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.

Key Dates

Start date
May 21, 2015
Status verified
Feb 2022
Primary completion
Nov 9, 2020
Completion
Nov 9, 2020

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Dose Escalation Arm 1
  • Experimental: Dose Escalation Arm 2
  • Experimental: Dose Escalation Arm 3
  • Experimental: Dose Expansion Arm 1
  • Experimental: Dose Expansion Arm 2
  • Experimental: Dose Expansion Arm 3

Primary Outcome Measure

Incidence of dose limiting toxicities during the first cycle of study treatment [ Time Frame: Cycle 1 (28 days) ]

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