A Phase II Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Myelofibrosis

Sponsor
Baxalta now part of Shire
Study ID
NCT02584777
Phase
PHASE2
Status
Withdrawn

Conditions

  • Primary Myelofibrosis

Eligibility Criteria

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

Interventions

Study Details

To evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of pacritinib in Asian subjects with myelofibrosis (MF), which includes primary MF (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocythemia MF (PET-MF).

Key Dates

Start date
Nov 30, 2015
Status verified
May 2021
Primary completion
Sep 30, 2017
Completion
Aug 31, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pacritinib
    Oral administration

Primary Outcome Measure

Proportion of participants achieving a ≥35% reduction in spleen volume [ Time Frame: Baseline to Week 24 ]

Related Studies