Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

CTI BioPharma

ClinicalTrials.gov Identifier:

NCT01773187

First received: January 18, 2013

Last updated: December 15, 2016

Last verified: December 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2013

Last Updated Date

December 15, 2016

Start Date ^ICMJE

December 2012

Primary Completion Date

January 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01773187 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Pacritinib
Drug: Best Available Therapy

Study Arms

Experimental: Pacritinib
Pacritinib 400 mg taken orally, once daily

Intervention: 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.

Intervention: Drug: Best Available Therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

327

Completion Date

June 2016

Primary Completion Date

January 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, New Zealand, Russian Federation, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01773187

Other Study ID Numbers ^ICMJE

PERSIST-1 (PAC325)

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

CTI BioPharma

Study Sponsor ^ICMJE

CTI BioPharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

James Dean, MD, PhD

CTI BioPharma

PRS Account

CTI BioPharma

Verification Date

December 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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