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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis

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Trial Information

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


Inclusion Criteria:



- Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)

- Palpable splenomegaly ≥ 5 cm on physical examination

- Score ≥ 3 for at least two symptoms on the MPN-SAF TSS or score ≥ 4 for at least one
symptom on MPN-SAF TSS other than fatigue

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Outcome Description:

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)

Outcome Time Frame:

Baseline to Week 24

Safety Issue:

No

Principal Investigator

James Dean, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Cell Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

PERSIST-1 (PAC325)

NCT ID:

NCT01773187

Start Date:

December 2012

Completion Date:

August 2017

Related Keywords:

  • Primary Myelofibrosis
  • Post-Polycythemia Vera Myelofibrosis
  • Post-Essential Thrombocythemia Myelofibrosis
  • 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
  • Primary Myelofibrosis
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location

CTI Investigational Site 10001Morristown, New Jersey  07962