Myeloproliferative Neoplasms Clinical Trial

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis


This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).

Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Palpable splenomegaly at least 5 cm below the left costal margin
Confirmed diagnosis of PMF or post-PV/ET MF
Requires myelofibrosis therapy, in the opinion of the investigator
Classified as high risk OR intermediate-2 risk as defined by the International Prognostic Scoring System (IPSS) for PMF, or intermediate-1 risk (IPSS) associated with symptomatic splenomegaly, hepatomegaly, anemia (hemoglobin < 10.0 g/dL), and/or unresponsive to available therapy

Acceptable laboratory assessment obtained within 14 days prior to the first dose of study drug:

Absolute neutrophil count (ANC) ≥ 0.75 x 10^9/L in the absence of growth factor in the prior 7 days
Platelet Count ≥ 50 x 10^9/L (≥ 100 x 10^9/L if aspartate aminotransferase [AST] or alanine aminotransferase [ALT] is ≥ 2 x the upper limit of the normal range [ULN]) in the absence of platelet transfusion(s) or thrombopoietin mimetics in the prior 7 days
Peripheral blood blast count < 10%
AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)
Calculated creatinine clearance (CrCL) of ≥ 45 mL/min
Direct bilirubin ≤ 2.0 x ULN
Life expectancy of > 24 weeks
Males and females of childbearing potential must agree to use protocol-specified method(s) of contraception
Females who are nursing must agree to discontinue nursing before the first dose of study drug
Able to understand and willing to sign the informed consent form

Key Exclusion Criteria:

Prior splenectomy
Splenic irradiation within 3 months prior to the first dose of study drug
Eligible for allogeneic bone marrow or stem cell transplantation
Uncontrolled inter-current illness, per protocol.
Known positive status for human immunodeficiency virus (HIV)
Chronic active or acute viral hepatitis A, B, or C infection, or a hepatitis B or C carrier
Prior use of a JAK1 or JAK2 inhibitor
Use of chemotherapy, immunomodulating therapy, biologic therapy, radiation therapy, or investigational therapy within 4 weeks of the first dose of study drug
Presence of peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
Unwilling or unable to undergo a magnetic resonance imaging (MRI) or computed tomography (CT) scan

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Myeloproliferative Neoplasms


Phase 3

Estimated Enrollment:


Study ID:


Recruitment Status:



Sierra Oncology, Inc.

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There is 1 Location for this study

See Locations Near You

Phoenix Arizona, , United States

Escondido California, , United States

Stanford California, , United States

Jacksonville Florida, , United States

Atlanta Georgia, , United States

Chicago Illinois, , United States

Baltimore Maryland, , United States

Boston Massachusetts, , United States

Saint Louis Missouri, , United States

Durham North Carolina, , United States

Seattle Washington, , United States

Darlinghurst New South Wales, , Australia

Parkville New South Wales, , Australia

Saint Leonards New South Wales, , Australia

Brisbane Queensland, , Australia

Herston Queensland, , Australia

Adelaide South Australia, , Australia

Bedford Park South Australia, , Australia

Frankston Victoria, , Australia

Melbourne Victoria, , Australia

Perth Western Australia, , Australia

Wien Vienna, , Austria

Charleroi Hainaut, , Belgium

Antwerp , , Belgium

Leuven , , Belgium

Liege , , Belgium

Pleven , , Bulgaria

Plovdiv , , Bulgaria

Ruse , , Bulgaria

Sofia , , Bulgaria

Varna , , Bulgaria

Edmonton Alberta, , Canada

Vancouver British Columbia, , Canada

Hamilton Ontario, , Canada

Toronto Ontario, , Canada

Hradec Kralove Vychodocesky KRAJ, , Czechia

Brno , , Czechia

Ostrava , , Czechia

Aalborg , , Denmark

Herlev , , Denmark

Toulouse cedex 9 Midi-pyrenees, , France

Pierre Bénite Cedex Rhone-alpes, , France

Le Kremlin Bicetre Cedex , , France

Lens , , France

Lille Cedex , , France

Marseille Cedex 9 , , France

Nantes cedex 1 , , France

Paris , , France

Pessac Cedex , , France

Villejuif Cedex , , France

München Bayern, , Germany

Leipzig Sachsen, , Germany

Dresden , , Germany

Dusseldorf , , Germany

Freiburg , , Germany

Hamburg , , Germany

Mainz , , Germany

Mannheim , , Germany

Budapest , , Hungary

Debrecen , , Hungary

Kaposvár , , Hungary

Afula , , Israel

Ashkelon , , Israel

Haifa , , Israel

Jerusalem , , Israel

Tel Aviv , , Israel

Ogaki City Gifu, , Japan

Kitaku Sapporo Hokkaido, , Japan

Osaka Sayama Osaka, , Japan

Osaka-City Osaka, , Japan

Bunkyo-ku, Tokyo , , Japan

Fukushima City , , Japan

Kumamoto City , , Japan

Matsuyama , , Japan

Okayama , , Japan

Seoul , , Korea, Republic of

Maastricht , , Netherlands

Nijmegen , , Netherlands

Rotterdam , , Netherlands

Utrecht , , Netherlands

Lodz Lodzkie, , Poland

Lublin Lubelskie, , Poland

Kraków Malopolskie, , Poland

Warszawa Mazowiekie, , Poland

Gdansk Pomorskie, , Poland

Poznan Wielkopolskie, , Poland

Bialystok , , Poland

Brzozow , , Poland

Chorzow , , Poland

Arad , , Romania

Brasov , , Romania

Bucuresti , , Romania

Cluj-Napoca , , Romania

Iasi , , Romania

Singapore , , Singapore

Majadahonda Madrid, , Spain

Pamplona Navarra, , Spain

Badalona , , Spain

Barcelona , , Spain

Valencia , , Spain

Zaragoza , , Spain

Lund Skane, , Sweden

Stockholm , , Sweden

Uddevalla , , Sweden

Örebro , , Sweden

Kaohsiung , , Taiwan

Leicester England, , United Kingdom

London England, , United Kingdom

Manchester England, , United Kingdom

Newcastle Upon Tyne England, , United Kingdom

Oxford England, , United Kingdom

Cardiff Wales, , United Kingdom

Northern Ireland , , United Kingdom

Nottingham , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms


Phase 3

Estimated Enrollment:


Study ID:


Recruitment Status:



Sierra Oncology, Inc.

How clear is this clinincal trial information?


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