Conditions: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Keywords: Primary myelofibrosis Secondary myelofibrosis PMF PET-MF PPV-MF Ruxolitinib resistant or intolerant previously treated myelofibrosis smoothened inhibitor oral single agent.
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 21
Healthy volunteers: no

Brief summary:
A lead-in cohort of \~20 patients with primary or secondary myelofibrosis previously treated with 1 or more Janus kinase inhibitors enrolled to single-agent glasdegib to evaluate safety and tolerability. Following the lead-in, a phase 2, double blind, 2-arm study, randomized 2:1 to oral single-agent glasdegib versus placebo in 201 patients resistant or intolerant to ruxolitinib.

Detailed description:

Arms:
arm 1: Oral daily dose of glasdegib (PF-04449913) 100 mg tablet in a continuous regimen of 28-day cycles. arm 2: Oral daily dose of placebo 100 mg tablet in a continuous regimen of 28-day cycles.

Interventions: intervention 1: Glasdegib (PF-04449913) intervention 2: Placebo
Intervention descriptions: intervention 1: Oral daily dose of glasdegib (PF-04449913) 100 mg tablet in a continuous regimen of 28-day cycles. intervention 2: Oral daily dose of placebo 100 mg tablet in a continuous regimen of 28-day cycles.

Protocol document: