Phase 2 Study: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Previously Treated With Ruxolitinib

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
CTI BioPharma
Study ID
NCT04884191
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This was an open-label, randomized, dose-finding study in patients with primary or secondary MF (Dynamic International Prognostic Scoring System \[DIPSS\] risk score of Intermediate-1 to High-Risk) who were previously treated with ruxolitinib. The study was designed to support a pacritinib dosage selection decision with evaluation of 3 dosages.

Key Dates

Start date
Jul 31, 2017
Status verified
May 2022
Primary completion
Sep 4, 2019
Completion
Sep 4, 2019

Study Design

Enrollment
165 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pacritinib 100 mg QD
  • Experimental: Pacritinib 100 mg BID
  • Experimental: Pacritinib 200 mg BID

Primary Outcome Measure

Spleen Volume Reduction Response (≥ 35%) [ Time Frame: From Baseline to Weeks 12 and 24 ]

Locations (33)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
City of HopeDuarteCalifornia91010-
UCLA Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Stanford Cancer InstituteStanfordCalifornia94305-
Yale School of MedicineNew HavenConnecticut06520-
Medical Faculty Associates, Inc.Washington D.C.District of Columbia20037-
Florida Cancer Specialists & Research InstituteFort MyersFlorida33901-
Florida Cancer Specialists & Research InstituteSt. PetersburgFlorida33705-
Florida Cancer Specialists & Research InstituteWest Palm BeachFlorida33401-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
The University of Chicago Medical CenterChicagoIllinois60637-
University of Kansas Cancer CenterWestwoodKansas66205-
Ochsner Medical CenterNew OrleansLouisiana70121-
Saint Agnes HospitalBaltimoreMaryland21229-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
Columbia UniversityNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Medical CollegeNew YorkNew York10021-
University of RochesterRochesterNew York14642-
Duke University HospitalDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Tennessee OncologyNashvilleTennessee37203-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Texas Health Science Center at San Antonio School of MedicineSan AntonioTexas78229-
University of Utah School of MedicineSalt Lake CityUtah84112-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital· Phoenix, AZCity of Hope· Duarte, CAUCLA Jonsson Comprehensive Cancer Center· Los Angeles, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAStanford Cancer Institute· Stanford, CAYale School of Medicine· New Haven, CT

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