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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
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
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
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
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
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
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
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
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
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
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
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
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02124746
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02124746