Myeloproliferative Neoplasms Clinical Trial

Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF


This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).

Participants will be randomized to receive either MMB or BAT for 24 weeks during the randomized treatment phase, after which they will be eligible to receive MMB in an extended treatment phase for up to an additional 204 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 subjects planning to continue treatment with MMB following the end of the study, the End of Treatment, 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 left costal margin
Confirmed diagnosis of PMF in accordance, or Post-PV/ET MF

Currently or previously treated with ruxolitinib for PMF or Post-PV/ET MF for at least 28 days, and characterized by

Requirement for RBC transfusion while on ruxolitinib treatment, OR

Dose adjustment of ruxolitinib to < 20 mg twice daily at start of or during ruxolitinib treatment AND at least one of the following while on ruxolitinib treatment:

≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 thrombocytopenia, OR
≥ CTCAE Grade 3 anemia, OR
≥ CTCAE Grade 3 hematoma (bleed)
High risk OR intermediate-2 risk as defined by Dynamic International Prognostic Scoring System (DIPSS), OR intermediate-1 risk as defined by DIPSS and associated with symptomatic splenomegaly, and/or hepatomegaly
If receiving myelofibrosis therapy, must be on a stable dose of the same regimen for at least 2 weeks prior to screen date and through the screening period
If not receiving myelofibrosis therapy, must remain off therapy for at least 2 weeks prior to screen date and through the screening period

Acceptable laboratory assessments obtained within 14 days prior to Randomization

Absolute neutrophil count (ANC) > 0.75 x 10^9/L in the absence of growth factor in the prior 7 days
Peripheral blood blast count < 10%
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x the upper limit of the normal range (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 of ≥ 45 mL/min
Direct bilirubin ≤ 2.0 x ULN
Life expectancy > 24 weeks
Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years post-menopausal)
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 MMB
Able to understand and willing to sign informed consent form (ICF)

Key Exclusion Criteria:

Prior splenectomy
Splenic irradiation within 3 months prior to Randomization
Use of investigational agent within 28 days prior to Randomization
Prior treatment with MMB
Hematopoietic growth factor (granulocyte growth factor, erythropoiesis stimulating agent, thrombopoietin mimetic) within 28 days prior to Randomization
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 hepatitis B or C carrier
Presence of peripheral neuropathy ≥ CTCAE Grade 2
Unwilling or unable to undergo a MRI or CT Scan per study protocol requirements

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

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Los Angeles California, , United States

Gainesville Florida, , United States

Atlanta Georgia, , United States

Kansas City Kansas, , United States

Baltimore Maryland, , United States

Saint Louis Missouri, , United States

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Cleveland Ohio, , United States

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Lille cedex , , France

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Paris , , France

Pierre Benite Cedex , , France

Toulouse , , France

Villejuif Cedex , , France

Dresden , , Germany

Hamburg , , Germany

Koln , , Germany

Mannheim , , Germany

Ashkelon , , Israel

Haifa , , Israel

Jerusalem , , Israel

Tel-Aviv , , Israel

Bologna , , Italy

Firenze , , Italy

Genova , , Italy

Milano , , Italy

Novara , , Italy

Roma , , Italy

Varese , , Italy

Badalona , , Spain

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Madrid , , Spain

Salamanca , , Spain

Valencia , , Spain

Zaragoza , , Spain

Birmingham England, , United Kingdom

Leeds England, , United Kingdom

Leicester England, , United Kingdom

London England, , 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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