Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005202

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005202
  •   2013/10/17
  •   2013/01/18
  •   no
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Secondary IDs

  •   NCT01773187  (ClinicalTrials.gov)
  •   PERSIST-1 (PAC325)  (Cell Therapeutics)
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Health Condition or Problem studied

  •   Primary Myelofibrosis
  •   Post-polycythemia Vera Myelofibrosis
  •   Post-essential Thrombocythemia Myelofibrosis
  •   D47.4 -  Osteomyelofibrosis
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Interventions/Observational Groups

  •   Drug: Pacritinib
  •   Drug: Best Available Therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Efficacy; 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)

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Secondary Outcome

- 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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Countries of Recruitment

  •   United States
  •   Australia
  •   Belgium
  •   Czech Republic
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Netherlands
  •   New Zealand
  •   Russian Federation
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2012/12/31
  •   270
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Cell Therapeutics
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    • Cell Therapeutics
    • James Dean, MD, PhD 
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    • Valentina Zhukova-Harrill, MD 
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    •   +44 (0) 131-200-6320
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2014/01/06
* This entry means the parameter is not applicable or has not been set.