NCT02370706

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	PIM447	pan-pim inhibitor
DRUG	Ruxolitinib	JAK1/JAK2 inhibitor
DRUG	LEE011	CDK4/6 inhibitor

Timeline

• Start date: 2015-05-21
• Primary completion: 2020-11-09
• Completion: 2020-11-09
• First posted: 2015-02-25
• Last updated: 2022-02-09

Locations

9 sites across 8 countries: Australia, Canada, France, Germany, Italy, Netherlands, Singapore, United Kingdom