Extended Access of Momelotinib in Adults With Myelofibrosis

• ClinicalTrials.gov Identifier: NCT03441113
• Recruitment Status: Active, not recruiting
• First Posted: February 22, 2018
• Last Update Posted: May 16, 2024
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: February 15, 2018
• First Posted Date: February 22, 2018
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: May 3, 2018
• Estimated Primary Completion Date: December 31, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 12, 2019): Number of Participants Who Had Access to, and Received the Intervention [ Time Frame: Participants will be assessed every 12 weeks until discontinuation. Participation in this extended access study has been an average of approximately 8 months. ]
• Original Primary Outcome Measures (submitted: February 15, 2018): Number of Participants Who Had Access to, and Received the Intervention [ Time Frame: Up to 96 Weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Extended Access of Momelotinib in Adults With Myelofibrosis
• Official Title: Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Neoplasms
• Post-polycythemia Vera Myelofibrosis (Post-PV MF)
• Primary Myelofibrosis (PMF)
• Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)

Intervention

Drug: MMB

Tablet(s) administered orally once daily

Other Names:

• GS-0387
• CYT387

Study Arms

• 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.
  Intervention: Drug: MMB
• 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.
  Intervention: Drug: MMB
• 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..
  Intervention: Drug: MMB
• 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.
  Intervention: Drug: MMB

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 16, 2023): 237
• Original Estimated Enrollment (submitted: February 15, 2018): 200
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: December 31, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• Known hypersensitivity to MMB, its metabolites, or formulation excipients

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Poland, Romania, Singapore, Spain, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT03441113
• Other Study ID Numbers: 219627; 2017-004350-42 ( EudraCT Number ); SRA-MMB-4365 ( Other Identifier: Sierra Oncology, Inc. ); 219627 ( Other Identifier: GlaxoSmithKline )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: GlaxoSmithKline
• Original Responsible Party: Gilead Sciences
• Current Study Sponsor: GlaxoSmithKline
• Original Study Sponsor: Gilead Sciences
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: May 2024