- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01998828
Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
April 14, 2020 updated by: Sierra Oncology, Inc.
A Phase 2, Open-label, Randomized Study to Evaluate the Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia
This open-label study is to determine the safety and efficacy of momelotinib in participants with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet received treatment with a Janus kinase (JAK) inhibitor.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Frankston, Victoria, Australia
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Parkville, Victoria, Australia
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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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La Tronche, France
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Nantes Cedex 1, France
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Paris, France
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Dresden, Germany
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Minden, Germany
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Arizona
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Scottsdale, Arizona, United States
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California
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Whittier, California, United States
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Mississippi
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Tupelo, Mississippi, United States
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Missouri
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Saint Louis, Missouri, United States
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Texas
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Houston, Texas, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of either PV or ET as defined by the 2008 World Health Organization (WHO) Diagnostic Criteria
- Requires treatment for PV or ET, in the opinion of the study investigator
- Intolerant of, resistant to, or refuses current or available treatment for PV or ET
- Direct bilirubin ≤ 2.0 x upper limit of the normal range (ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
- Calculated creatinine clearance (CrCl) of ≥ 45 mL/min
- Life expectancy > 24 weeks
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse 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 comprehend and willing to sign informed consent form
Exclusion Criteria:
- Prior splenectomy
- Uncontrolled intercurrent 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
- Myeloproliferative neoplasm-directed therapy, other than aspirin, hydroxyurea, anagrelide, and/or phlebotomy, within 21 days prior to the first dose of study drug
- Anagrelide within 7 days prior to the first dose of study drug
- Presence of peripheral neuropathy ≥ Grade 2
- Unwilling or unable to take oral medication
- Prior use of a JAK1 or JAK2 inhibitor
- Use of strong CYP3A4 inducers within 1 week prior to the first dose of study drug
- QTc interval > 450 msec, unless attributed to bundle branch block
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Momelotinib 100 mg PV
Participants with polycythemia vera will receive 100 mg of momelotinib.
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Momelotinib tablet administered orally once daily
Other Names:
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Experimental: Momelotinib 200 mg PV
Participants with polycythemia vera will receive 200 mg of momelotinib.
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Momelotinib tablet administered orally once daily
Other Names:
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Experimental: Momelotinib 100 mg ET
Participants with essential thrombocythemia will receive 100 mg of momelotinib.
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Momelotinib tablet administered orally once daily
Other Names:
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Experimental: Momelotinib 200 mg ET
Participants with essential thrombocythemia will receive 200 mg of momelotinib.
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Momelotinib tablet administered orally once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall response rate
Time Frame: Up to 24 weeks
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For the PV Cohort, overall response rate (ORR) is defined as the proportion of participants with all of the following at some point during the treatment period:
For the ET Cohort, overall response rate is defined as the proportion of participants with all of the following at some point during the treatment period:
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Up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Confirmed overall response rate
Time Frame: Up to 24 weeks
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Confirmed overall response rate is defined as the proportion of participants who meet all the criteria listed for the primary endpoints of PV or ET, sustained for at least 12 weeks.
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Up to 24 weeks
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Proportion of participants with hematocrit < 45% in the absence of phlebotomy that lasts at least 4 weeks
Time Frame: Up to 24 weeks
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Up to 24 weeks
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Proportion of participants with WBC < 10 x 10^9/L that lasts at least 4 weeks
Time Frame: Up to 24 weeks
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Up to 24 weeks
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Proportion of participants with platelet count ≤ 400 x 10^9/L that lasts at least 4 weeks
Time Frame: Up to 24 weeks
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Up to 24 weeks
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Proportion of participants with resolution of palpable splenomegaly that lasts at least 4 weeks
Time Frame: Up to 24 weeks
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Up to 24 weeks
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Proportion of participants with ≥ 10 point decrease in modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPNSAF TSS) compared to baseline that lasts at least 12 weeks
Time Frame: Up to 24 weeks
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Up to 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Peter Lee, MD, PhD, Gilead Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2014
Primary Completion (Actual)
March 17, 2015
Study Completion (Actual)
May 7, 2015
Study Registration Dates
First Submitted
November 25, 2013
First Submitted That Met QC Criteria
November 25, 2013
First Posted (Estimate)
December 2, 2013
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 14, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Myeloproliferative Disorders
- Blood Coagulation Disorders
- Blood Platelet Disorders
- Bone Marrow Neoplasms
- Hematologic Neoplasms
- Thrombocytosis
- Thrombocythemia, Essential
- Polycythemia Vera
- Polycythemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide
Other Study ID Numbers
- GS-US-354-0101
- 2013-004105-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Novartis PharmaceuticalsCompletedPolycythemia Vera (PV)United States
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PharmaEssentia Japan K.K.Recruiting
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Ionis Pharmaceuticals, Inc.RecruitingPhlebotomy Dependent Polycythemia VeraUnited States, Canada, Hungary, United Kingdom, Australia, Poland
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Northwestern UniversityNational Cancer Institute (NCI); Celgene; The Leukemia and Lymphoma SocietyWithdrawnPrimary Myelofibrosis | Polycythemia Vera, Post-Polycythemic Myelofibrosis PhaseUnited States
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Novartis PharmaceuticalsTerminatedPrimary Myelofibrosis | Post-Polycythemia Vera | Post-Essential ThrombocytopeniaUnited States
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CelgeneRecruitingPrimary Myelofibrosis | Myeloproliferative Disorders | Anemia | Myelofibrosis | Post-Polycythemia Vera MyelofibrosisFrance, Belgium, Austria, Spain, Australia, Canada, Japan, United States, Korea, Republic of, Israel, Italy, China, Czechia, Germany, Greece, Ireland, Poland, United Kingdom, Romania, Hong Kong, Hungary, Colombia, Russian Federation, ... and more
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CelgeneImpact Biomedicines, Inc., a wholly owned subsidiary of Celgene CorporationActive, not recruitingPrimary Myelofibrosis | Myelofibrosis | Post-Polycythemia VeraAustralia, Austria, Belgium, China, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Ireland, United Kingdom
Clinical Trials on Momelotinib
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Sierra Oncology, Inc.CompletedPrimary Myelofibrosis | Post-Polycythemia Vera Myelofibrosis | Post-Essential Thrombocythemia MyelofibrosisUnited States, France, Germany, Spain, Israel, Bulgaria, Romania, Japan, Taiwan, Korea, Republic of, Australia, Belgium, Canada, Netherlands, Singapore, Poland, Hungary, Denmark, Sweden, United Kingdom, Czechia, Austria
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Sierra Oncology LLC - a GSK companyTerminatedMetastatic Pancreatic Ductal AdenocarcinomaUnited States
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Sierra Oncology LLC - a GSK companyCompletedPrimary Myelofibrosis | Post-polycythemia Vera Myelofibrosis | Post-essential Thrombocythemia MyelofibrosisKorea, Republic of, Canada, Hungary, Israel, Spain, United States, Australia, Taiwan, Singapore, Germany, Italy, France, Belgium, New Zealand, Austria, United Kingdom, Denmark, Bulgaria, Poland, Czechia, Romania, Sweden
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Sierra Oncology, Inc.CompletedPrimary Myelofibrosis | Post-Polycythemia Vera Myelofibrosis | Post-Essential Thrombocythemia MyelofibrosisUnited States, Canada, Australia
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Sierra Oncology, Inc.CompletedPrimary Myelofibrosis | Post-Polycythemia Vera | Post-Essential Thrombocythemia MyelofibrosisUnited States, Canada
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GlaxoSmithKlineNo longer availablePrimary Myelofibrosis | Myelofibrosis
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M.D. Anderson Cancer CenterGlaxoSmithKlineNot yet recruiting
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Sierra Oncology, Inc.CompletedPrimary Myelofibrosis | Post-Polycythemia Vera Myelofibrosis | Post-Essential Thrombocythemia MyelofibrosisUnited States, Canada, Australia
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Sierra Oncology LLC - a GSK companyCompletedPrimary Myelofibrosis | Polycythemia Vera | Essential Thrombocythemia | Post-Polycythemia Vera Myelofibrosis | Post-Essential Thrombocythemia MyelofibrosisUnited States, France, Canada, Germany, Australia
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Sierra Oncology, Inc.TerminatedRelapsed Metastatic KRAS-Mutated Non-Small Cell Lung CancerUnited States