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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
Date last updated
18/06/2023

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
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
Secondary ID [1] 0 0
2013-004476-36
Secondary ID [2] 0 0
GS-US-352-1154
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Myelofibrosis 0 0
Post-Polycythemia Vera Myelofibrosis 0 0
Post-Essential Thrombocythemia Myelofibrosis 0 0
Polycythemia Vera 0 0
Essential Thrombocythemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
From the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154.
Secondary outcome [1] 0 0
Splenic Response Rate
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Duration of Splenic Response
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Transfusion Independence Response Rate
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Duration of Transfusion Independence Response
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Anemia Response Rate
Assessment method [5] 0 0
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).
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Duration of Anemia Response
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
Rate of RBC Transfusion
Assessment method [7] 0 0
The average number of RBC units per subject month during the parent study and/or Study GS-US-352-1154.
Timepoint [7] 0 0
From the first dose of momelotinib in the parent study until the last dose of momelotinib in Study GS-US-352-1154.
Secondary outcome [8] 0 0
Overall Survival
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Progression-Free Survival
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
From baseline in the parent study until the last response assessment, up to 30 days following permanent discontinuation of momelotinib.
Secondary outcome [10] 0 0
Leukemia-Free Survival
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
From baseline in the parent study until the date of the last assessment, up to 30 days following permanent discontinuation of momelotinib.

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known hypersensitivity to momelotinib, its metabolites, or formulation excipients

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/12/2018
Sample size
Target
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Frankston
Recruitment hospital [2] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
- Frankston
Recruitment postcode(s) [2] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
France
State/province [15] 0 0
La Tronche
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
Germany
State/province [17] 0 0
Minden

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sierra Oncology LLC - a GSK company
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02124746