Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis



Status:Active, not recruiting
Conditions:Cancer, Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:December 6, 2013
End Date:March 2019

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A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

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.


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.
We found this trial at
12
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