Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia (PAC326)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02055781|
Recruitment Status : Terminated
First Posted : February 5, 2014
Results First Posted : November 18, 2021
Last Update Posted : November 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis||Drug: Pacritinib Drug: Best Available Therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||311 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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.
Drug: Best Available Therapy
- Spleen Volume Reduction [ Time Frame: Baseline to Week 24 ]Proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline to week 24 as measured by magnetic resonance imaging (MRI) or computed tomography (CT).
- Total Symptom Score (TSS) Reduction [ Time Frame: Baseline to Week 24 ]Proportion of patients achieving a ≥ 50% reduction in the total symptom score from baseline to Week 24 on the Myeloproliferative Neoplasm Symptom Assessment Form 2.0 (MPN-SAF TSS 2.0). Responses (on a scale from 0 [absent] to 10 [worst imaginable]) to questions about symptoms (tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under the ribs on the left side) were used to calculate the TSS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055781
|Study Director:||Simran Singh||Sr. Director, Head of Clinical Operations|