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Extended Access of Momelotinib in Adults With Myelofibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03441113
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : June 22, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE February 15, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date June 22, 2023
Actual Study Start Date  ICMJE May 3, 2018
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: February 15, 2018)
Number of Participants Who Had Access to, and Received the Intervention [ Time Frame: Up to 96 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extended Access of Momelotinib in Adults With Myelofibrosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Post-polycythemia Vera Myelofibrosis (Post-PV MF)
  • Primary Myelofibrosis (PMF)
  • Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Intervention  ICMJE Drug: MMB
Tablet(s) administered orally once daily
Other Names:
  • GS-0387
  • CYT387
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 16, 2023)
237
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
200
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Romania,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03441113
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party GlaxoSmithKline
Original Responsible Party Gilead Sciences
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP