Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia

Conditions

• Post-essential Thrombocythemia Myelofibrosis
• Post-polycythemia Vera Myelofibrosis
• Primary Myelofibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pacritinib — DRUG
• Best Available Therapy — DRUG

Study Details

Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.

Key Dates

Start date

Feb 28, 2014

Status verified

Oct 2021

Primary completion

Apr 30, 2016

Completion

Apr 30, 2016

Study Design

Enrollment

311 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pacritinib, Once Daily
  Pacritinib 400 mg QD
• Experimental: Pacritinib, Twice Daily
  Pacritinib 200 mg BID
• Active Comparator: Best Available Therapy
  BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry.

Primary Outcome Measure

Spleen Volume Reduction [ Time Frame: Baseline to Week 24 ]

Locations (50)

Find similar trials in Scottsdale, AZ

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