Extended Access of Momelotinib in Adults With Myelofibrosis
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| ClinicalTrials.gov Identifier: NCT03441113 |
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Recruitment Status :
Enrolling by invitation
First Posted : February 22, 2018
Last Update Posted : January 11, 2022
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Sponsor:
Sierra Oncology, Inc.
Information provided by (Responsible Party):
Sierra Oncology, Inc.
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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-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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-polycythemia Vera Myelofibrosis (Post-PV MF) Primary Myelofibrosis (PMF) Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) | Drug: MMB | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 400 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | May 3, 2018 |
| Estimated Primary Completion Date : | December 2026 |
| Estimated Study Completion Date : | December 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Essential thrombocythemia
Primary myelofibrosis
Polycythemia vera
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: MMB
Tablet(s) administered orally once daily
Other Names:
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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.
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Drug: MMB
Tablet(s) administered orally once daily
Other Names:
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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..
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Drug: MMB
Tablet(s) administered orally once daily
Other Names:
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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.
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Drug: MMB
Tablet(s) administered orally once daily
Other Names:
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Primary Outcome Measures :
- 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. ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441113
Locations
Show 87 study locations
Sponsors and Collaborators
Sierra Oncology, Inc.
Investigators
| Study Director: | Sierra Oncology, Inc. | Sierra Oncology, Inc. |
| Responsible Party: | Sierra Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT03441113 |
| Other Study ID Numbers: |
SRA-MMB-4365 2017-004350-42 ( EudraCT Number ) |
| First Posted: | February 22, 2018 Key Record Dates |
| Last Update Posted: | January 11, 2022 |
| Last Verified: | November 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Polycythemia Vera Primary Myelofibrosis Polycythemia Thrombocytosis Thrombocythemia, Essential Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Bone Marrow Neoplasms Hematologic Neoplasms |
Neoplasms by Site Neoplasms Blood Platelet Disorders Blood Coagulation Disorders Hemorrhagic Disorders N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |