Myeloproliferative Neoplasms Clinical Trial

Pacritinib Versus Best Available Therapy to Treat Myelofibrosis

Summary

Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.

View Full Description

Full Description

Multicenter, randomized, controlled, phase 3 trial comparing the safety and efficacy of pacritinib with that of BAT in patients with primary or secondary myelofibrosis. Approximately 322 eligible patients will be randomized in a 2:1 allocation to pacritinib (400mg QD) or BAT (includes any physician-selected treatment for myelofibrosis with the exclusion of JAK inhibitors (inhibitors of Janus kinases)). Spleen volume will be measured by MRI or CT at baseline and every 12 weeks thereafter. An independent radiology facility (IRF), blind to treatment assignments, will measure spleen volumes. Patients will also be followed for safety, Leukemia Free Survival (LFS), Overall Survival (OS), frequency of red blood cell (RBC) and platelet transfusions, and other exploratory endpoints. An Independent Data Monitoring Committee (IDMC) will evaluate the safety of pacritinib.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

327

Study ID:

NCT01773187

Recruitment Status:

Terminated

Sponsor:

CTI BioPharma

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 4 Locations for this study

See Locations Near You

CTI Investigational Site 10002
Scottsdale Arizona, 85259, United States
CTI Investigational Site 10004
Omaha Nebraska, 68198, United States
CTI Investigational Site 10001
Morristown New Jersey, 07962, United States
CTI Investigational Site 10003
Greenville South Carolina, 29601, United States
CTI Investigational Site 61006
Box Hill , , Australia
CTI Investigational Site 61001
Coffs Harbour , , Australia
CTI Investigational Site 61005
Geelong , , Australia
CTI Investigational Site 61003
Gosford , , Australia
CTI Investigational Site 61004
Hobart , , Australia
CTI Investigational Site 61002
Milton , , Australia
CTI Investigational Site 32002
Antwerp , , Belgium
CTI Investigational Site 32003
Antwerp , , Belgium
CTI Investigational Site 32001
Brugge , , Belgium
CTI Investigational Site 32005
Bruxelles , , Belgium
CTI Investigational Site 32004
La Louviere , , Belgium
CTI Investigational Site 42003
Brno , , Czechia
CTI Investigational Site 42001
Olomouc , , Czechia
CTI Investigational Site 42002
Plzen , , Czechia
CTI Investigational Site 42004
Prague , , Czechia
CTI Investigational Site 33005
Amiens , , France
CTI Investigational Site 33006
Caen , , France
CTI Investigational Site 33011
Grenoble , , France
CTI Investigational Site 33012
Lens , , France
CTI Investigational Site 33007
Lille , , France
CTI Investigational Site 33001
Nimes Cedex , , France
CTI Investigational Site 33004
Paris , , France
CTI Investigational Site 33008
Paris , , France
CTI Investigational Site 33009
Pessac , , France
CTI Investigational Site 33010
Pierre Benite , , France
CTI Investigational Site 33003
Strasbourg , , France
CTI Investigational Site 33002
Toulouse , , France
CTI Investigational Site 49006
Berlin , , Germany
CTI Investigational Site 49007
Berlin , , Germany
CTI Investigational Site 49003
Dresden , , Germany
CTI Investigational Site 49008
Essen , , Germany
CTI Investigational Site 49002
Freiburg , , Germany
CTI Investigational Site 49001
Koln , , Germany
CTI Investigational Site 49005
Mainz , , Germany
CTI Investigational Site 49004
Munchen , , Germany
CTI Investigational Site 49009
Munster , , Germany
CTI Investigational Site 36002
Budapest , , Hungary
CTI Investigational Site 36005
Debrecen , , Hungary
CTI Investigational Site 36006
Gyula , , Hungary
CTI Investigational Site 36003
Kaposvar , , Hungary
CTI Investigational Site 36004
Kecskemet , , Hungary
CTI Investigational Site 36001
Szeged , , Hungary
CTI Investigational Site 36008
Szolnok , , Hungary
CTI Investigational Site 36007
Szombathely , , Hungary
CTI Investigational Site 39003
Bologna , , Italy
CTI Investigational Site 39001
Firenze , , Italy
CTI Investigational Site 39005
Milano , , Italy
CTI Investigational Site 39004
Monza , , Italy
CTI Investigational Site 39002
Padova , , Italy
CTI Investigational Site 39008
Reggio Emilia , , Italy
CTI Investigational Site 39006
Rimini , , Italy
CTI Investigational Site 31001
Amsterdam , , Netherlands
CTI Investigational Site 31002
Maastricht , , Netherlands
CTI Investigational Site 31003
Rotterdam , , Netherlands
CTI Investigational Site 31004
Utrecht , , Netherlands
CTI Investigational Site 64001
Christchurch , , New Zealand
CTI Investigational Site 64004
Dunedin , , New Zealand
CTI Investigational Site 64002
Hamilton , , New Zealand
CTI Investigational Site 64003
Takapuna , , New Zealand
CTI Investigational Site 70011
Izhevsk , , Russian Federation
CTI Investigational Site 70008
Moscow , , Russian Federation
CTI Investigational Site 70009
Moscow , , Russian Federation
CTI Investigational Site 70002
Petrozavodsk , , Russian Federation
CTI Investigational Site 70010
Saint Petersburg , , Russian Federation
CTI Investigational Site 70005
Samara , , Russian Federation
CTI Investigational Site 70006
Sochi , , Russian Federation
CTI Investigational Site 70001
St. Petersburg , , Russian Federation
CTI Investigational Site 70004
St. Petersburg , , Russian Federation
CTI Investigational Site 70007
Volgograd , , Russian Federation
CTI Investigational Site 44004
Birmingham , , United Kingdom
CTI Investigational Site 44008
Bournemouth , , United Kingdom
CTI Investigational Site 44002
Cambridge , , United Kingdom
CTI Investigational Site 44003
Cardiff , , United Kingdom
CTI Investigational Site 44001
London , , United Kingdom
CTI Investigational Site 44007
London , , United Kingdom
CTI Investigational Site 44006
Manchester , , United Kingdom
CTI Investigational Site 44005
Oxford , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

327

Study ID:

NCT01773187

Recruitment Status:

Terminated

Sponsor:


CTI BioPharma

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider