Brief Summary
This is an extended-access, long-term safety study for participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) who have not experienced progression of disease and who have tolerated momelotinib (MMB) treatment while participating in previous MMB clinical trials (GS-US-352-0101 \[NCT01969838\], GS-US-352-1214 \[NCT02101268\], GS-US-352-1154 \[NCT02124746\] and SRA-MMB-301 \[NCT04173494\]). Participants in all cohorts continuing MMB treatment will discontinue MMB from the previous study and initiate MMB in this study at the same dose they were receiving in the previous study. Following the final data cut-off date, the study may move into the post analysis continuation of treatment (PACT) phase in which participants will continue to receive MMB and will be monitored and receive follow-up care in accordance with standard local clinical practice.
Brief Title
Extended Access of Momelotinib in Adults With Myelofibrosis
Categories
Completion Date
Completion Date Type
Estimated
Conditions
PRIMARY MYELOFIBROSIS
Eligibility Criteria
Inclusion Criteria:
* Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* Did not discontinue treatment with MMB for any reason while enrolled in Studies GS US 352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* A negative serum or urine pregnancy test is required for female participants of childbearing potential
* Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Any Grade 3 or 4 (common terminology criteria for adverse events \[CTCAE\] Version 4.03) non-hematologic toxicity in the prior study that the Investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
* Any AE requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
* Ability and agreement to attend protocol-specified visits at the study site
* Able to comprehend and willing to sign the informed consent form
Exclusion Criteria:
* Known hypersensitivity to MMB, its metabolites, or formulation excipients
* Incomplete recovery from major surgery prior to Day 1 of this study
* Pregnant or lactating females
* Presence of greater than or equal to (\>=) Grade 3 (CTCAE Version 4.03) peripheral neuropathy
* Known positive status for human immunodeficiency virus (HIV)
* Known chronic active or acute viral hepatitis A, B, or C infection
* Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* Did not discontinue treatment with MMB for any reason while enrolled in Studies GS US 352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* A negative serum or urine pregnancy test is required for female participants of childbearing potential
* Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Any Grade 3 or 4 (common terminology criteria for adverse events \[CTCAE\] Version 4.03) non-hematologic toxicity in the prior study that the Investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
* Any AE requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
* Ability and agreement to attend protocol-specified visits at the study site
* Able to comprehend and willing to sign the informed consent form
Exclusion Criteria:
* Known hypersensitivity to MMB, its metabolites, or formulation excipients
* Incomplete recovery from major surgery prior to Day 1 of this study
* Pregnant or lactating females
* Presence of greater than or equal to (\>=) Grade 3 (CTCAE Version 4.03) peripheral neuropathy
* Known positive status for human immunodeficiency virus (HIV)
* Known chronic active or acute viral hepatitis A, B, or C infection
Inclusion Criteria
Inclusion Criteria:
* Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* Did not discontinue treatment with MMB for any reason while enrolled in Studies GS US 352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* A negative serum or urine pregnancy test is required for female participants of childbearing potential
* Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Any Grade 3 or 4 (common terminology criteria for adverse events \[CTCAE\] Version 4.03) non-hematologic toxicity in the prior study that the Investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
* Any AE requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
* Ability and agreement to attend protocol-specified visits at the study site
* Able to comprehend and willing to sign the informed consent form
* Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* Did not discontinue treatment with MMB for any reason while enrolled in Studies GS US 352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
* A negative serum or urine pregnancy test is required for female participants of childbearing potential
* Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Any Grade 3 or 4 (common terminology criteria for adverse events \[CTCAE\] Version 4.03) non-hematologic toxicity in the prior study that the Investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
* Any AE requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to Baseline within the 30 days from last MMB administration to Day 1 of this study
* Ability and agreement to attend protocol-specified visits at the study site
* Able to comprehend and willing to sign the informed consent form
Gender
All
Gender Based
false
Keywords
Neoplasms
Momelotinib
Extended access
Post-polycythemia Vera Myelofibrosis (Post-PV MF)
Primary Myelofibrosis (PMF)
Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03441113
Org Class
Industry
Org Full Name
GlaxoSmithKline
Org Study Id
219627
Overall Status
Active, not recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
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)
Primary Outcomes
Outcome Measure
Number of Participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity
Outcome Time Frame
From study start until each participant transitions to PACT (up to approximately 556 weeks)
Secondary Ids
Secondary Id
SRA-MMB-4365
Secondary Id
2017-004350-42
Secondary Id
2023-508018-41-00
Secondary Id
2023
Secondary Id
2017
Secondary Outcomes
Outcome Time Frame
From the start of the study drug until the date of death due to any cause or database lock, whichever comes first (up to approximately 556 weeks)
Outcome Measure
Overall survival (OS)
Outcome Time Frame
From the start of the study drug until the date of any evidence of leukemic transformation and/or death due to any cause or database lock, whichever comes first (up to approximately 556 weeks)
Outcome Measure
Leukemia free survival (LFS)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Swati Goel
Investigator Email
swgoel@montefiore.org
Investigator Phone
718-920-6310 / 718-920-4137
Categories Mesh Debug
Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- MYELOPROLIFERATIVE DISORDERS
Blood Disorders --- HEMATOLOGIC DISEASES
MeSH Terms
PRIMARY MYELOFIBROSIS
NEOPLASMS
MYELOPROLIFERATIVE DISORDERS
BONE MARROW DISEASES
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
N-(CYANOMETHYL)-4-(2-((4-(4-MORPHOLINYL)PHENYL)AMINO)-4-PYRIMIDINYL)BENZAMIDE