Oral Pacritinib Versus Best Available Therapy to Treat Myelofibrosis With Thrombocytopenia



Status:Terminated
Conditions:Cancer, Blood Cancer, Hematology, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/24/2018
Start Date:December 2013
End Date:November 2016

Use our guide to learn which trials are right for you!

A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

The primary hypothesis of the study is that treatment with either once-daily or twice-daily
pacritinib results in a greater proportion of patients with thrombocytopenia and
myelofibrosis achieving ≥ 35% reduction in spleen volume from baseline to Week 24 than
treatment with Best Available Therapy, and a greater proportion of patients achieving a ≥ 50%
reduction in total symptom score from baseline to Week 24 as measured by the
Myeloproliferative Neoplasm Symptom Assessment Form 2.0.

The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib
(pooled once-daily [QD] and twice-daily [BID] dosing arms) with that of best available
therapy (BAT) in patients with thrombocytopenia and primary myelofibrosis (PMF),
post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia
myelofibrosis (PET-MF). The efficacy co-endpoints for this analysis are 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 and the proportion of
patients achieving a ≥ 50% reduction in total symptom score (TSS) from baseline to Week 24 as
measured by the Myeloproliferative Neoplasm Symptom Assessment Form 2.0 (MPN-SAF TSS 2.0).

Inclusion Criteria:

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

- Thrombocytopenia (platelet count ≤ 100,000/µL) at any time after signing informed
consent

- 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

- At least 6 months from prior splenic irradiation

- At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or
thrombopoietic agent

- Not pregnant, not lactating, and agree to use effective birth control

- Able and willing to undergo frequent MRI or CT assessments and complete symptom
assessments using a patient-reported outcome instrument

Exclusion Criteria:

- Prior treatment with more than 2 JAK2 inhibitors or with pacritinib

- There is no maximum cumulative prior JAK2 inhibitor treatment

- 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

- Active bleeding that requires hospitalization during the screening period

- 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
We found this trial at
51
sites
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ann Arbor, Michigan 48197
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Boulder, Colorado
?
mi
from
Boulder, CO
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Duarte, California 91010
?
mi
from
Duarte, CA
Click here to add this to my saved trials
1717 13th St
Everett, Washington 98201
(425) 297-5500
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
?
mi
from
Everett, WA
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
706 Holiday Drive
Galveston, Texas 77573
?
mi
from
Galveston, TX
Click here to add this to my saved trials
?
mi
from
Goshen, IN
Click here to add this to my saved trials
Green Bay, Wisconsin 54301
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46254
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Kogarah, New South Wales 2217
?
mi
from
Kogarah,
Click here to add this to my saved trials
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Leesburg, Virginia 20176
?
mi
from
Leesburg, VA
Click here to add this to my saved trials
Lincoln, Nebraska 68506
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40207
?
mi
from
Louisville, KY
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15232
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33705
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84112
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Sioux City, IA
Click here to add this to my saved trials
Southfield, Michigan 48075
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Tucson, Arizona 85712
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Washington, District of Columbia 20037
?
mi
from
Washington,
Click here to add this to my saved trials