Trial · NCT01369498
Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis
NCT01369498, Phase 2, Completed, Gilead Sciences; results first posted 2020-07-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis. Trials, record NCT01369498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01369498
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis
- NCT number
- NCT01369498
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Myelofibrosis
- Interventions
- Simtuzumab, Ruxolitinib
- First posted
- 2011-06-09
- Last updated
- 2020-07-01
- Results first posted
- 2020-07-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score | Baseline; Week 24 | Overall response for the study drug is defined by the reduction in bone marrow fibrosis score which is on a scale of 0-3 where 0 indicates the scattered linear reticulin with no fiber intersections representing normal marrow and 3 indicates dense increase in reticulin fibrosis with fiber intersections, often with osteosclerosis. Reduction from baseline of score indicates improvement in clinical condition. |
| Secondary | Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) | Baseline; Weeks 12, 24 and any time post baseline (enrollment up to 94 weeks) | Overall response for the study drug was defined by the rate of clinical improvement in hemoglobin, platelet or ANC. Clinical improvement in hemoglobin was defined as a ≥ 2 g/dL increase from baseline in hemoglobin level and transfusion independent (absence of red blood cell (RBC) transfusions in prior 8 weeks and applicable only for participants with baseline hemoglobin level of \< 10 g/dL); clinical improvement in platelets was defined as a ≥ 100% increase from baseline in platelet count and an absolute platelet count of ≥ 50 x 10\^9/L (applicable only for participants with baseline platelet count \< 50 x 10\^9/L); clinical improvement in ANC is defined as a ≥ 100% increase from baseline in ANC and an ANC of ≥ 0.5 x 10\^9/L (applicable only for participants with baseline ANC \< 1 x 10\^9/L). |
| Secondary | Percentage of Participants With Adverse Events (AEs) | First dose date up to the last dose date (maximum: 94 weeks) plus 28 days | |
| Secondary | Change From Baseline in Myelofibrosis Symptoms Assessment Score | Baseline; Days 43 and 85 of Cycles 1-7 (cycle=12 weeks) | Myelofibrosis symptom assessment was performed using myeloproliferative neoplasm symptoms assessment form (MPN-SAF) which is a 27-item questionnaire to address symptom burden and quality of life. The form consists of 27 questions which are scored on a scale of 0-10 by participants based on how symptoms are affecting them, where 0 indicates less symptoms while 10 indicated more severe symptoms and greater inactivity. The MPN-SAF score was calculated at each visit for each participant as an average of the scales for each question and all answered questions. If the number of questions not answered at 1 visit was \> 10, then the MPN-SAF score for that visit was taken as missing. A negative change from Baseline indicated improvement. |
| Secondary | Change From Baseline in Cytokine Levels | Baseline; Week 24 | Biomarker samples were collected to evaluate the effects of SIM treatment on markers of serum and plasma cytokines. |
| Secondary | Percentage of Participants With Anti-Simtuzumab Antibody Formation | Baseline; Day 85 of Cycles 1 to 5 (cycle=12 weeks) | Blood samples were collected for the presence of anti-SIM antibodies which was determined using a validated electro-chemiluminescent (ECL) assay screening test. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score | Baseline; Week 24 | The Per Protocol Analysis Set included participants who were randomized, received at least 1 dose of study drug, did not violate any major entry criteria, and had at least 80% adherence with study drug. | percentage of participants | NUMBER |
| SECONDARY | Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) | Baseline; Weeks 12, 24 and any time post baseline (enrollment up to 94 weeks) | Participants in Per Protocol Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | First dose date up to the last dose date (maximum: 94 weeks) plus 28 days | The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Myelofibrosis Symptoms Assessment Score | Baseline; Days 43 and 85 of Cycles 1-7 (cycle=12 weeks) | Participants in the Per Protocol Analysis Set with available data were analyzed. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Cytokine Levels | Baseline; Week 24 | The cytokine analysis was not performed. | ||
| SECONDARY | Percentage of Participants With Anti-Simtuzumab Antibody Formation | Baseline; Day 85 of Cycles 1 to 5 (cycle=12 weeks) | Participants in Safety Analysis Set with available data were analyzed. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score | Stage 1: SIM 200 mg | 0 | 90% Confidence Interval 0.0 to 23.8 | percentage of participants | |
| Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score | Stage 1: SIM 700 mg | 16.7 | 90% Confidence Interval 3.0 to 43.8 | percentage of participants | |
| Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score | Stage 2: SIM 200 mg+Ruxolitinib | 6.7 | 90% Confidence Interval 0.3 to 27.9 | percentage of participants | |
| Rate of Clinical Response as Defined by the Percentage of Participants With Reduction at Week 24 From Baseline in the Bone Marrow Fibrosis Score | Stage 2: SIM 700 mg+Ruxolitinib | 13.3 | 90% Confidence Interval 2.4 to 36.3 | percentage of participants | |
| Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) | Stage 1: SIM 200 mg | Week 12 | 0 | 90% Confidence Interval 0.0 to 25.9 | percentage of participants |
| Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) | Stage 1: SIM 700 mg | Week 12 | 0 | 90% Confidence Interval 0.0 to 25.9 | percentage of participants |
| Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) | Stage 2: SIM 200 mg+Ruxolitinib | Week 12 | 0 | 90% Confidence Interval 0.0 to 28.3 | percentage of participants |
| Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) | Stage 2: SIM 700 mg+Ruxolitinib | Week 12 | 0 | 90% Confidence Interval 0.0 to 25.9 | percentage of participants |
| Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) | Stage 1: SIM 200 mg | Week 24 | 0 | 90% Confidence Interval 0.0 to 25.9 | percentage of participants |
| Rate of Clinical Response as Defined by the Percentage of Participants With Improvement in Hemoglobin, Platelet, or Absolute Neutrophil Count (ANC) | Stage 1: SIM 700 mg | Week 24 | 0 | 90% Confidence Interval 0.0 to 25.9 | percentage of participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage 1: SIM 200 mg | 12 | |
| Overall Study | STARTED | Stage 1: SIM 700 mg | 12 | |
| Overall Study | STARTED | Stage 2: SIM 200 mg+Ruxolitinib | 15 | |
| Overall Study | STARTED | Stage 2: SIM 700 mg+Ruxolitinib | 15 | |
| Overall Study | COMPLETED | Stage 1: SIM 200 mg | 0 | |
| Overall Study | COMPLETED | Stage 1: SIM 700 mg | 0 | |
| Overall Study | COMPLETED | Stage 2: SIM 200 mg+Ruxolitinib | 0 | |
| Overall Study | COMPLETED | Stage 2: SIM 700 mg+Ruxolitinib | 0 | |
| Overall Study | NOT COMPLETED | Stage 1: SIM 200 mg | 12 | |
| Overall Study | NOT COMPLETED | Stage 1: SIM 700 mg | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,208
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 | Stage 1: SIM 200 mg | 2 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1: SIM 700 mg | 2 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 2: SIM 200 mg+Ruxolitinib | 5 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 2: SIM 700 mg+Ruxolitinib | 4 | 15 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Stage 1: SIM 200 mg | 2 | 12 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Stage 1: SIM 700 mg | 0 | 12 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Stage 2: SIM 200 mg+Ruxolitinib | 0 | 15 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Stage 2: SIM 700 mg+Ruxolitinib | 0 | 15 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Stage 1: SIM 200 mg | 1 | 12 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Stage 1: SIM 700 mg | 0 | 12 |
1 to 10 of 1,208Source ClinicalTrials.gov
See all 1,208 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: SIM 200 mg | 0 | 12 |
| Total, all-cause mortality | Stage 1: SIM 700 mg | 1 | 12 |
| Total, all-cause mortality | Stage 2: SIM 200 mg+Ruxolitinib | 1 | 15 |
| Total, all-cause mortality | Stage 2: SIM 700 mg+Ruxolitinib | 0 | 15 |
| Total, other adverse events | Stage 1: SIM 200 mg | 12 | 12 |
| Total, other adverse events | Stage 1: SIM 700 mg | 12 | 12 |
| Total, other adverse events | Stage 2: SIM 200 mg+Ruxolitinib | 15 | 15 |
| Total, other adverse events | Stage 2: SIM 700 mg+Ruxolitinib | 15 | 15 |
| Total, serious adverse events | Stage 1: SIM 200 mg | 8 | 12 |
| Total, serious adverse events | Stage 1: SIM 700 mg | 1 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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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The record and each of its lists are JSON, twenty rows a page. No key.
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