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Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

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ClinicalTrials.gov Identifier: NCT01773187
Recruitment Status : Terminated
First Posted : January 23, 2013
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma

Brief Summary:
The primary hypothesis of the study is that treatment with pacritinib results in a greater proportion of patients achieving ≥ 35% reduction in spleen volume from baseline to Week 24 than treatment with BAT.

Condition or disease Intervention/treatment Phase
Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Drug: Pacritinib Drug: Best Available Therapy Phase 3

Detailed Description:
The primary objective is to compare the efficacy of pacritinib with that of best available therapy (BAT) in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF); the efficacy measure for this analysis is the 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) scan.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Study Start Date : December 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Pacritinib
Pacritinib 400 mg taken orally, once daily
Drug: Pacritinib
Active Comparator: Best Available Therapy
BAT includes any physician-selected treatment for PMF, PPV-MF, or PET-MF with the exclusion of JAK inhibitors (inhibitors of Janus kinases). For example, BAT may include hydroxyurea, glucocorticoids, erythropoietic agents, immunomodulatory agents, mercaptopurine, danazol, interferons, cytarabine, melphalan, or other agents.
Drug: Best Available Therapy



Primary Outcome Measures :
  1. To compare the efficacy of pacritinib with that of best available therapy (BAT) [ Time Frame: Baseline to Week 24 ]
    To compare the efficacy of pacritinib with that of best available therapy (BAT) in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF); the efficacy measure for this analysis is the proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline to week 24 by magnetic resonance imaging (MRI) or computed tomography (CT)


Secondary Outcome Measures :
  1. Symptomatic Efficacy [ Time Frame: Baseline to week 24 ]
    To compare pacritinib with best available therapy with respect to the proportion of patients with >= 50% reduction in total score from baseline to week 24 on the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF TSS)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
  • Palpable splenomegaly ≥ 5 cm on physical examination
  • Total Symptom Score >13 on the MPN-SAF TSS 2.0, not including the inactivity question
  • Patients who are platelet or red blood cell transfusion-dependent are eligible
  • Adequate white blood cell counts (with low blast counts), liver function, and renal function
  • No spleen radiation therapy for 6-12 months
  • Last therapy for myelofibrosis was 2-4 weeks ago, including any erythropoietic or thrombopoietic agent
  • Not pregnant, not lactating, and agree to use effective birth control

Exclusion Criteria:

  • Prior treatment with a JAK2 inhibitor
  • History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
  • Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
  • Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction
  • Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers
  • Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
  • Life expectancy < 6 months

Information from the National Library of Medicine

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): NCT01773187


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Locations
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United States, Arizona
CTI Investigational Site 10002
Scottsdale, Arizona, United States, 85259
United States, Nebraska
CTI Investigational Site 10004
Omaha, Nebraska, United States, 68198
United States, New Jersey
CTI Investigational Site 10001
Morristown, New Jersey, United States, 07962
United States, South Carolina
CTI Investigational Site 10003
Greenville, South Carolina, United States, 29601
Australia
CTI Investigational Site 61006
Box Hill, Australia
CTI Investigational Site 61001
Coffs Harbour, Australia
CTI Investigational Site 61005
Geelong, Australia
CTI Investigational Site 61003
Gosford, Australia
CTI Investigational Site 61004
Hobart, Australia
CTI Investigational Site 61002
Milton, Australia
Belgium
CTI Investigational Site 32002
Antwerp, Belgium
CTI Investigational Site 32003
Antwerp, Belgium
CTI Investigational Site 32001
Brugge, Belgium
CTI Investigational Site 32005
Bruxelles, Belgium
CTI Investigational Site 32004
La Louviere, Belgium
Czechia
CTI Investigational Site 42003
Brno, Czechia
CTI Investigational Site 42001
Olomouc, Czechia
CTI Investigational Site 42002
Plzen, Czechia
CTI Investigational Site 42004
Prague, Czechia
France
CTI Investigational Site 33005
Amiens, France
CTI Investigational Site 33006
Caen, France
CTI Investigational Site 33011
Grenoble, France
CTI Investigational Site 33012
Lens, France
CTI Investigational Site 33007
Lille, France
CTI Investigational Site 33001
Nimes Cedex, France
CTI Investigational Site 33004
Paris, France
CTI Investigational Site 33008
Paris, France
CTI Investigational Site 33009
Pessac, France
CTI Investigational Site 33010
Pierre Benite, France
CTI Investigational Site 33003
Strasbourg, France
CTI Investigational Site 33002
Toulouse, France
Germany
CTI Investigational Site 49006
Berlin, Germany
CTI Investigational Site 49007
Berlin, Germany
CTI Investigational Site 49003
Dresden, Germany
CTI Investigational Site 49008
Essen, Germany
CTI Investigational Site 49002
Freiburg, Germany
CTI Investigational Site 49001
Koln, Germany
CTI Investigational Site 49005
Mainz, Germany
CTI Investigational Site 49004
Munchen, Germany
CTI Investigational Site 49009
Munster, Germany
Hungary
CTI Investigational Site 36002
Budapest, Hungary
CTI Investigational Site 36005
Debrecen, Hungary
CTI Investigational Site 36006
Gyula, Hungary
CTI Investigational Site 36003
Kaposvar, Hungary
CTI Investigational Site 36004
Kecskemet, Hungary
CTI Investigational Site 36001
Szeged, Hungary
CTI Investigational Site 36008
Szolnok, Hungary
CTI Investigational Site 36007
Szombathely, Hungary
Italy
CTI Investigational Site 39003
Bologna, Italy
CTI Investigational Site 39001
Firenze, Italy
CTI Investigational Site 39005
Milano, Italy
CTI Investigational Site 39004
Monza, Italy
CTI Investigational Site 39002
Padova, Italy
CTI Investigational Site 39008
Reggio Emilia, Italy
CTI Investigational Site 39006
Rimini, Italy
Netherlands
CTI Investigational Site 31001
Amsterdam, Netherlands
CTI Investigational Site 31002
Maastricht, Netherlands
CTI Investigational Site 31003
Rotterdam, Netherlands
CTI Investigational Site 31004
Utrecht, Netherlands
New Zealand
CTI Investigational Site 64001
Christchurch, New Zealand
CTI Investigational Site 64004
Dunedin, New Zealand
CTI Investigational Site 64002
Hamilton, New Zealand
CTI Investigational Site 64003
Takapuna, New Zealand
Russian Federation
CTI Investigational Site 70011
Izhevsk, Russian Federation
CTI Investigational Site 70008
Moscow, Russian Federation
CTI Investigational Site 70009
Moscow, Russian Federation
CTI Investigational Site 70002
Petrozavodsk, Russian Federation
CTI Investigational Site 70010
Saint Petersburg, Russian Federation
CTI Investigational Site 70005
Samara, Russian Federation
CTI Investigational Site 70006
Sochi, Russian Federation
CTI Investigational Site 70001
St. Petersburg, Russian Federation
CTI Investigational Site 70004
St. Petersburg, Russian Federation
CTI Investigational Site 70007
Volgograd, Russian Federation
United Kingdom
CTI Investigational Site 44004
Birmingham, United Kingdom
CTI Investigational Site 44008
Bournemouth, United Kingdom
CTI Investigational Site 44002
Cambridge, United Kingdom
CTI Investigational Site 44003
Cardiff, United Kingdom
CTI Investigational Site 44001
London, United Kingdom
CTI Investigational Site 44007
London, United Kingdom
CTI Investigational Site 44006
Manchester, United Kingdom
CTI Investigational Site 44005
Oxford, United Kingdom
Sponsors and Collaborators
CTI BioPharma
Investigators
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Study Director: James Dean, MD, PhD CTI BioPharma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT01773187     History of Changes
Other Study ID Numbers: PERSIST-1 (PAC325)
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: December 2016
Keywords provided by CTI BioPharma:
Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Post-Essential Thrombocythemia Myelofibrosis
Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocythemia
Myeloproliferative Disorders
Bone Marrow Disease
Hematologic Diseases
Blood Platelet Disorders
Hemorrhagic Disorders
Splenomegaly
Pacritinib
MPN-SAF
MPN-SAF TSS
Anemia
Myeloproliferative
Myeloproliferative Neoplasm
Spleen
Spleen volume
Thrombocytopenia
SB1518
Additional relevant MeSH terms:
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Polycythemia Vera
Primary Myelofibrosis
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders