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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03441113




Registration number
NCT03441113
Ethics application status
Date submitted
15/02/2018
Date registered
22/02/2018
Date last updated
16/05/2024

Titles & IDs
Public title
Extended Access of Momelotinib in Adults With Myelofibrosis
Scientific title
Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Secondary ID [1] 0 0
2017-004350-42
Secondary ID [2] 0 0
219627
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Post-polycythemia Vera Myelofibrosis (Post-PV MF) 0 0
Primary Myelofibrosis (PMF) 0 0
Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) 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 - MMB

Other: Cohort 1: Study GS-US-352-0101 - Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-0101 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Other: Cohort 2: Study GS-US-352-1214 - Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1214 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Other: Cohort 3: Study GS-US-352-1154 - Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1154 until MMB receives regulatory approval and is commercially available, or development of the product ceases..

Other: Cohort 4: Study SRA-MMB-301 - Participants will continue to receive the same dosage regimen as in the previous MMB study SRA-MMB-301 until MMB receives regulatory approval and is commercially available, or development of the product ceases.


Treatment: Drugs: MMB
Tablet(s) administered orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Had Access to, and Received the Intervention
Timepoint [1] 0 0
Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months.

Eligibility
Key inclusion criteria
Key

* Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* Able to comprehend and willing to sign the 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 MMB, 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
Accrual to date
Final
237
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Icon Cancer Care Wesley - Hyde Park
Recruitment hospital [2] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [3] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [4] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [5] 0 0
GSK Investigational Site - Frankston
Recruitment hospital [6] 0 0
Frankston Hospital - Frankston
Recruitment hospital [7] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre - Parkville
Recruitment hospital [11] 0 0
GSK Investigational Site - Perth
Recruitment hospital [12] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
4812 - Hyde Park
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
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31 99 - Frankston
Recruitment postcode(s) [5] 0 0
3199 - Frankston
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3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment postcode(s) [9] 0 0
6160 - Perth
Recruitment outside Australia
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Majadahonda (Madrid)
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Taoyuan
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England
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Lanarkshire
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.
Trial website
https://clinicaltrials.gov/study/NCT03441113
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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/NCT03441113