Trial · NCT02124746
Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
NCT02124746, Phase 2, Completed, Sierra Oncology LLC - a GSK company; results first posted 2021-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia. Trials, record NCT02124746. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02124746
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
- NCT number
- NCT02124746
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Conditions
- Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia
- Interventions
- Momelotinib
- First posted
- 2014-04-28
- Last updated
- 2023-06-18
- Other registries' IDs
- eudract:2013-004476-36
- Results first posted
- 2021-02-05
- Limitations and caveats
- Cohort 3 was discontinued and excluded from the safety and efficacy analyses.~The survival analyses were subject to a high level of censoring.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities | From the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154. | Long-term safety and tolerability profile of momelotinib based on safety data (adverse events and selected hematology and chemistry laboratory parameters) collected after the first dose of momelotinib in the parent study. |
| Secondary | Splenic Response Rate | From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | The number of subjects achieving a spleen response, defined as a reduction of 50% or more in palpable splenomegaly of a spleen that was at least 10 cm below the LCM at baseline, or a spleen that was palpable at \> 5 cm and \< 10 cm below the LCM at baseline becoming not palpable for at least 56 days, using baseline of the parent study as the reference. |
| Secondary | Duration of Splenic Response | From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | The interval from the first onset of splenic response (in the parent study or Study GS-US-352-1154) to the earliest date of loss of splenic response. Loss of response was defined as the reduction of splenomegaly by \< 50% among responders (with splenomegaly ≥ 10 cm below the LCM at baseline) that lasts ≥ 56 days, or the recurrence of \> 0 cm splenomegaly among responders (with splenomegaly \> 5 and \< 10 cm at baseline) that lasts ≥ 56 days. Duration of splenic response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date. |
| Secondary | Transfusion Independence Response Rate | From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | The number of transfusion dependent subjects at entry to a parent study who became transfusion-independent for ≥ 12 weeks at any time from the first dose of momelotinib in the parent study until the end of Study GS-US-352-1154. |
| Secondary | Duration of Transfusion Independence Response | From baseline in the parent study until the last assessment date in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | The interval from the first onset date of transfusion independence (in the parent study or Study GS-US-352-1154) to the earliest date of loss of response for participants who are transfusion dependent at baseline in the parent study. Loss of TI response was defined as receiving an RBC transfusion after achieving a TI response. Duration of transfusion independence response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date. |
| Secondary | Anemia Response Rate | From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | The number of subjects achieving an anemia response, defined as: * Achieving transfusion independence for ≥ 12 weeks, for subjects who were transfusion-dependent at baseline in the parent study, or * Having ≥ 2 g/dL increase in Hgb from baseline for ≥ 12 weeks, for subjects with Hgb \< 10 g/dL at baseline in the parent study who were not transfusion-dependent (Cohort 1) or who were transfusion-independent (Cohort 2). |
| Secondary | Duration of Anemia Response | From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | The interval from the first onset of anemia response (in the parent study or Study GS-US-352-1154) to the earliest date of loss of anemia response. Loss of anemia response was defined as having any RBC transfusion after achieving an anemia response. Duration of anemia response was measured by descriptive statistics. Data from responders who maintained their response was censored at the last assessment date. |
| Secondary | Rate of RBC Transfusion | From the first dose of momelotinib in the parent study until the last dose of momelotinib in Study GS-US-352-1154. | The average number of RBC units per subject month during the parent study and/or Study GS-US-352-1154. |
| Secondary | Overall Survival | From baseline in the parent study until the date of last contact or last response assessment, up to 30 days following permanent discontinuation of momelotinib. | The interval from the first dose of momelotinib in the parent study until death from any cause. Overall survival was analyzed using the Kaplan-Meier method. Data from subjects who were lost to follow-up or remained alive until the end of the study were censored at the date of last contact or last response assessment. |
| Secondary | Progression-Free Survival | From baseline in the parent study until the last response assessment, up to 30 days following permanent discontinuation of momelotinib. | The interval from the first dose of momelotinib in the parent study until the first documentation of definitive progressive disease as defined in 2006 IWG-MRT or death due to any cause. Subjects who were free of progression were censored at the last assessment date. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities | From the first dose of momelotinib in the parent study to 30 days following permanent discontinuation of momelotinib in Study GS-US-352-1154. | It was pre-specified that safety outcomes would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore data for this outcome measure are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Splenic Response Rate | From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | Subjects with splenomegaly \>5 cm at baseline in the parent studies who were enrolled in Study GS-US-352-1154 were evaluable for splenic response assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Splenic Response | From baseline in the parent study until the last spleen assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | Duration of splenic response was assessed for spleen responders who enrolled in Study GS-US-352-1154 only. | days | MEDIAN |
| SECONDARY | Transfusion Independence Response Rate | From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | Subjects who were transfusion dependent at baseline in the parent studies and were enrolled in Study GS-US-352-1154 were evaluable for transfusion independence response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Transfusion Independence Response | From baseline in the parent study until the last assessment date in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | Duration of transfusion independence response was assessed for transfusion independence responders who were enrolled in Study GS-US-352-1154. | days | MEDIAN |
| SECONDARY | Anemia Response Rate | From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | Subjects who were anemia response-evaluable at baseline in the parent studies and were enrolled in Study GS-US-352-1154 were evaluable for anemia response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Anemia Response | From baseline in the parent study until the last assessment in Study GS-US-352-1154, up to 30 days following permanent discontinuation of momelotinib. | Duration of anemia response was assessed for anemia responders who were enrolled in Study GS-US-352-1154. | days | MEDIAN |
| SECONDARY | Rate of RBC Transfusion | From the first dose of momelotinib in the parent study until the last dose of momelotinib in Study GS-US-352-1154. | It was pre-specified that safety outcomes would be analyzed and summarized by starting dose in Study GS-US-352-1154. Therefore data for this outcome measure are presented for the total subjects enrolled to Study GS-US-352-1154 and not by cohort. | RBC units per month | MEDIAN |
| SECONDARY | Overall Survival | From baseline in the parent study until the date of last contact or last response assessment, up to 30 days following permanent discontinuation of momelotinib. | months | MEDIAN | |
| SECONDARY | Progression-Free Survival | From baseline in the parent study until the last response assessment, up to 30 days following permanent discontinuation of momelotinib. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities | Total | Subjects with ≥ one AE (any grade) | 73 | Participants | |
| Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities | Total | Subjects with ≥ one Grade 3 or higher AE | 62 | Participants | |
| Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities | Total | Subjects with Grade 3 lab toxicity (highest grade) | 36 | Participants | |
| Long Term Safety and Tolerability as Measured by the Incidence and Severity of Adverse Events and Clinical Laboratory Abnormalities | Total | Subjects with Grade 4 lab toxicity (highest grade) | 16 | Participants | |
| Splenic Response Rate | Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154) | 20 | Participants | ||
| Splenic Response Rate | Cohort 2 (YM387-II-02/GS-US-352-1154) | 19 | Participants | ||
| Splenic Response Rate | Cohort 4 (GS-US-352-1672/GS-US-352-1154) | 6 | Participants | ||
| Splenic Response Rate | Total | 45 | Participants | ||
| Duration of Splenic Response | Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154) | 1704.5 | Inter-Quartile Range 1153.5 to 2682.0 | days | |
| Duration of Splenic Response | Cohort 2 (YM387-II-02/GS-US-352-1154) | 736.0 | Inter-Quartile Range 197.0 to 1070.0 | days |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154) | 30 | |
| Overall Study | STARTED | Cohort 2 (YM387-II-02/GS-US-352-1154) | 22 | |
| Overall Study | STARTED | Cohort 4 (GS-US-352-1672/GS-US-352-1154) | 22 | |
| Overall Study | COMPLETED | Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154) | 11 | |
| Overall Study | COMPLETED | Cohort 2 (YM387-II-02/GS-US-352-1154) | 4 | |
| Overall Study | COMPLETED | Cohort 4 (GS-US-352-1672/GS-US-352-1154) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 (CCL09101/ CCL09101E/ GS-US-352-1154) | 19 | |
| Overall Study | NOT COMPLETED | Cohort 2 (YM387-II-02/GS-US-352-1154) | 18 | |
| Overall Study | NOT COMPLETED | Cohort 4 (GS-US-352-1672/GS-US-352-1154) | 22 |
Source ClinicalTrials.gov
Adverse events204
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Total | 27 | 74 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Total | 7 | 74 | |
| other | Leukopenia | Blood and lymphatic system disorders | Total | 9 | 74 | |
| other | Neutropenia | Blood and lymphatic system disorders | Total | 17 | 74 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Total | 28 | 74 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Total | 4 | 74 | |
| other | Atrial fibrillation | Cardiac disorders | Total | 4 | 74 | |
| other | Pericardial effusion | Cardiac disorders | Total | 4 | 74 | |
| other | Sinus bradycardia | Cardiac disorders | Total | 7 | 74 | |
| other | Ear discomfort | Ear and labyrinth disorders | Total | 4 | 74 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total | 8 | 74 |
| Total, other adverse events | Total | 73 | 74 |
| Total, serious adverse events | Total | 49 | 74 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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