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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02124746
Registration number
NCT02124746
Ethics application status
Date submitted
24/04/2014
Date registered
28/04/2014
Titles & IDs
Public title
Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
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Scientific title
Open-label Study to Assess the Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
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Secondary ID [1]
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2013-004476-36
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Secondary ID [2]
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GS-US-352-1154
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Primary Myelofibrosis
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Post-Polycythemia Vera Myelofibrosis
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Post-Essential Thrombocythemia Myelofibrosis
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Polycythemia Vera
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Essential Thrombocythemia
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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0
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Other blood disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Cancer
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Momelotinib
Experimental: Cohort 1 - Participants previously enrolled in Study CCL09191E will receive momelotinib for approximately 4 years.
Experimental: Cohort 2 - Participants previously enrolled in Study YM387-II-02 will receive momelotinib for approximately 4 years.
Experimental: Cohort 3 - Participants previously enrolled in Study GS-US-354-0101 will receive momelotinib for up to 4 years.
Cohort 3 was closed and all enrolled participants were discontinued from this study because parent Study GS-US-354-0101 was terminated.
Experimental: Cohort 4 - Participants previously enrolled in Study GS-US-352-1672 will receive momelotinib for approximately 4 years.
Treatment: Drugs: Momelotinib
Momelotinib tablets administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities
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Assessment method [1]
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Long-term safety and tolerability profile of momelotinib based on safety data (adverse events and selected hematology and chemistry laboratory parameters) collected after the first dose of momelotinib in the parent study.
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Timepoint [1]
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From the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154.
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Secondary outcome [1]
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Splenic Response Rate
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Assessment method [1]
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The number of subjects achieving a spleen response, defined as a reduction of 50% or more in palpable splenomegaly of a spleen that was at least 10 cm below the LCM at baseline, or a spleen that was palpable at \> 5 cm and \< 10 cm below the LCM at baseline becoming not palpable for at least 56 days, using baseline of the parent study as the reference.
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Timepoint [1]
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From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.
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Secondary outcome [2]
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Duration of Splenic Response
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Assessment method [2]
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The interval from the first onset of splenic response (in the parent study or Study GS-US-352-1154) to the earliest date of loss of splenic response. Loss of response was defined as the reduction of splenomegaly by \< 50% among responders (with splenomegaly = 10 cm below the LCM at baseline) that lasts = 56 days, or the recurrence of \> 0 cm splenomegaly among responders (with splenomegaly \> 5 and \< 10 cm at baseline) that lasts = 56 days.
Duration of splenic response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date.
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Timepoint [2]
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From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.
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Secondary outcome [3]
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Transfusion Independence Response Rate
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Assessment method [3]
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The number of transfusion dependent subjects at entry to a parent study who became transfusion-independent for = 12 weeks at any time from the first dose of momelotinib in the parent study until the end of Study GS-US-352-1154.
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Timepoint [3]
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From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.
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Secondary outcome [4]
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Duration of Transfusion Independence Response
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Assessment method [4]
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The interval from the first onset date of transfusion independence (in the parent study or Study GS-US-352-1154) to the earliest date of loss of response for participants who are transfusion dependent at baseline in the parent study. Loss of TI response was defined as receiving an RBC transfusion after achieving a TI response.
Duration of transfusion independence response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date.
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Timepoint [4]
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From baseline in the parent study until the last assessment date in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.
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Secondary outcome [5]
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Anemia Response Rate
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Assessment method [5]
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The number of subjects achieving an anemia response, defined as:
* Achieving transfusion independence for = 12 weeks, for subjects who were transfusion-dependent at baseline in the parent study, or
* Having = 2 g/dL increase in Hgb from baseline for = 12 weeks, for subjects with Hgb \< 10 g/dL at baseline in the parent study who were not transfusion-dependent (Cohort 1) or who were transfusion-independent (Cohort 2).
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Timepoint [5]
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From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.
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Secondary outcome [6]
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Duration of Anemia Response
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Assessment method [6]
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The interval from the first onset of anemia response (in the parent study or Study GS-US-352-1154) to the earliest date of loss of anemia response. Loss of anemia response was defined as having any RBC transfusion after achieving an anemia response.
Duration of anemia response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date.
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Timepoint [6]
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From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib.
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Secondary outcome [7]
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Rate of RBC Transfusion
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Assessment method [7]
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The average number of RBC units per subject month during the parent study and/or Study GS-US-352-1154.
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Timepoint [7]
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From the first dose of momelotinib in the parent study until the last dose of momelotinib in Study GS-US-352-1154.
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Secondary outcome [8]
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Overall Survival
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Assessment method [8]
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The interval from the first dose of momelotinib in the parent study until death from any cause.
Overall survival was analyzed using the Kaplan-Meier method. Data from subjects who were lost to follow-up or remained alive until the end of the study were censored at the date of last contact or last response assessment.
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Timepoint [8]
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From baseline in the parent study until the date of last contact or last response assessment, up to 30 days following permanent discontinuation of momelotinib.
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Secondary outcome [9]
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Progression-Free Survival
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Assessment method [9]
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The interval from the first dose of momelotinib in the parent study until the first documentation of definitive progressive disease as defined in 2006 IWG-MRT or death due to any cause.
Subjects who were free of progression were censored at the last assessment date.
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Timepoint [9]
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From baseline in the parent study until the last response assessment, up to 30 days following permanent discontinuation of momelotinib.
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Secondary outcome [10]
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Leukemia-Free Survival
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Assessment method [10]
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The interval from the first dose of momelotinib in the parent study until the first documented leukemic transformation or death from any cause. Leukemic transformation was documented in the adverse event electronic case report form.
Leukemia-free survival was analyzed using the Kaplan-Meier method. Subjects who were free of leukemia transformation were censored at the last assessment date.
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Timepoint [10]
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From baseline in the parent study until the date of the last assessment, up to 30 days following permanent discontinuation of momelotinib.
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Eligibility
Key inclusion criteria
Key
* Currently enrolled in study CCL09101E, or YM387-II-02, or successfully completed 24 weeks of study GS-US-352-1672
* Able to comprehend and willing to sign informed consent form
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known hypersensitivity to momelotinib, its metabolites, or formulation excipients
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/04/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/12/2018
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Sample size
Target
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Accrual to date
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Final
87
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- Frankston
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Recruitment hospital [2]
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- Parkville
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Recruitment postcode(s) [1]
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- Frankston
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Recruitment postcode(s) [2]
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- Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Maryland
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Michigan
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Country [7]
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United States of America
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State/province [7]
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Minnesota
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Country [8]
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United States of America
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State/province [8]
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Missouri
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Country [9]
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United States of America
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State/province [9]
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New York
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Country [10]
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United States of America
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State/province [10]
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Ohio
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Country [11]
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United States of America
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State/province [11]
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Texas
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Country [12]
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United States of America
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State/province [12]
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Utah
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Country [13]
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Canada
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State/province [13]
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Ontario
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Country [14]
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Canada
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State/province [14]
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Quebec
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Country [15]
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France
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State/province [15]
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La Tronche
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Country [16]
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France
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State/province [16]
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Paris
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Country [17]
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Germany
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State/province [17]
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Minden
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sierra Oncology LLC - a GSK company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.
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Trial website
https://clinicaltrials.gov/study/NCT02124746
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/46/NCT02124746/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/46/NCT02124746/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02124746