Trial · NCT00509899
Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
NCT00509899, Phase 1, Phase 2, Completed, Incyte Corporation; results first posted 2012-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis. Trials, record NCT00509899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00509899
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
- NCT number
- NCT00509899
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 154 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Myelofibrosis, Polycythemia Vera, Thrombocytosis
- Interventions
- Ruxolitinib
- First posted
- 2007-08-01
- Last updated
- 2018-03-12
- Results first posted
- 2012-08-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years. | Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline. Treatment-Related AEs are those with a definite, probable, possible or missing causality. A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above. A severe or life-threatening AE is based on intensity, according to National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) v3.0. |
| Primary | Percentage of Participants With Clinical Improvement (CI) Over Time | Week 12, 24, 36, 48 and 60 | Clinical improvement was defined according to the International Working Group Myelofibrosis Research and Treatment criteria, and required 1 of the following: 1. A ≥ 2 g/dL increase in Hemoglobin level or becoming transfusion independent; 2. Either a ≥ 50% reduction in palpable splenomegaly if spleen was ≥ 10 cm at Baseline or a spleen palpable at \> 5 cm at Baseline becomes not palpable; 3. A ≥ 100% increase in platelet count and an absolute platelet count of ≥ 50,000 x 10\^9/L or 4. A ≥ 100% increase in absolute neutrophil count (ANC) and an ANC of ≥ 0.5 x 10\^9/L. |
| Secondary | Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time | Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60 | For each visit, patients who had a missing value at the visit, dropped out of the study due to any reasons prior to the visit or had non-palpable spleen at baseline and then became palpable at the time of the visit were all considered as having not achieved the ≥ 50% reduction in spleen palpation length. |
| Secondary | Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time | Baseline, Weeks 4, 12, 24 and 48 | Spleen volume was assessed in a subgroup of 27 patients using magnetic resonance imaging (MRI) scans (or computed tomography (CT) scans in patients who were not candidates for MRI) of the abdomen in order to allow objective measurement of spleen volume using standard estimation techniques. For each visit, patients who had a missing value at the visit or dropped out of the study due to any reason prior to the visit were considered as not having achieved the ≥35% reduction in spleen volume. |
| Secondary | Change From Baseline in Myelofibrosis Total Symptom Score at Week 24 | Baseline and Week 24 | Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF). Abdominal discomfort, itching, muscle or bone pain, and night sweats are prominent and troubling symptoms in patients with MF. Therefore, the MFSAF-derived responses for these symptoms were analyzed as a total symptom score. Each symptom was assessed on a scale from 0 (absent), 1 (most favorable) to 10 (worst). The total symptom score is a sum of the individual scores and ranges from 0-40. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement. |
| Secondary | Change From Baseline to Week 24 in Health-Related Quality of Life | Baseline and Week 24 | Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life. |
| Secondary | Change From Baseline in Body Weight Over Time | Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60. | |
| Secondary | Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline and Week 24 | The ECOG performance status measures patients' functional status on the following scale: * 0=Fully active, no restrictions; * 1=Restricted in physically strenuous activity but ambulatory, able to carry out light work; * 2=Ambulatory and capable of all selfcare, unable to carry out any work activities; Up and about \> 50% of waking hours; * 3=Limited selfcare, confined to bed or chair more than 50% of waking hours; * 4=Completely disabled. Totally confined to bed or chair; * 5=Dead. Data reported indicate the number of participants with a change from Baseline score of -2, -1, 0 and 1. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years. | Safety population included all patients who received at least 1 dose of study medication. | participants | NUMBER |
| PRIMARY | Percentage of Participants With Clinical Improvement (CI) Over Time | Week 12, 24, 36, 48 and 60 | The intent-to-treat population included all patients who received at least 1 dose of study medication and had at least 1 follow-up assessment for safety and efficacy. N = the number of patients who had clinical response assessed during the time interval. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time | Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60 | Intent to treat population. A total of 16 patients had either a splenectomy prior to study entry, missing Baseline spleen values or had spleen lengths reported as 0 cm and were excluded. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time | Baseline, Weeks 4, 12, 24 and 48 | Patients with at least 1 Spleen-Volume Measurement. Patients who had not reached the visit were excluded from the analysis. In addition, at Week 48, 5 patients who did not have MRI measurement due to a protocol amendment were considered as not evaluable and were excluded from the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Myelofibrosis Total Symptom Score at Week 24 | Baseline and Week 24 | Intent-to-treat population for whom data was available. The MFSAF was implemented by protocol amendment while the study was ongoing. Hence data are available for only approximately 50% of enrolled patients. This analysis includes patients with a Baseline total symptom score ≥ 0; 8 patients were excluded because they had a Baseline score = 0. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Health-Related Quality of Life | Baseline and Week 24 | The safety population included all subjects who received at least 1 dose of study medication, and for whom data was available at both time points. The EORTC QLQ C30 was implemented by protocol amendment and as a result this data are available for only approximately 50% of the enrolled patients. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Body Weight Over Time | Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60. | Intent-to-treat population for patients who had reached each time point and for whom data was available. | kg | MEAN |
| SECONDARY | Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline and Week 24 | Intent-to-treat population for patients who had reached each time point and for whom data was available. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | 10 mg Bid | Any Treatment-Emergent Adverse Event | 30 | participants | |
| Number of Participants With Adverse Events (AEs) | 15 mg Bid | Any Treatment-Emergent Adverse Event | 35 | participants | |
| Number of Participants With Adverse Events (AEs) | 25 mg Bid | Any Treatment-Emergent Adverse Event | 47 | participants | |
| Number of Participants With Adverse Events (AEs) | 50 mg Bid | Any Treatment-Emergent Adverse Event | 5 | participants | |
| Number of Participants With Adverse Events (AEs) | All QD | Any Treatment-Emergent Adverse Event | 37 | participants | |
| Number of Participants With Adverse Events (AEs) | 10 mg Bid | Treatment-Related Adverse Events | 21 | participants | |
| Number of Participants With Adverse Events (AEs) | 15 mg Bid | Treatment-Related Adverse Events | 22 | participants | |
| Number of Participants With Adverse Events (AEs) | 25 mg Bid | Treatment-Related Adverse Events | 41 | participants | |
| Number of Participants With Adverse Events (AEs) | 50 mg Bid | Treatment-Related Adverse Events | 4 | participants | |
| Number of Participants With Adverse Events (AEs) | All QD | Treatment-Related Adverse Events | 29 | participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10 mg Bid | 30 | |
| Overall Study | STARTED | 15 mg Bid | 35 | |
| Overall Study | STARTED | 25 mg Bid | 47 | |
| Overall Study | STARTED | 50 mg Bid | 5 | |
| Overall Study | STARTED | 25 mg qd | 6 | |
| Overall Study | STARTED | 50 mg qd | 22 | |
| Overall Study | STARTED | 100 mg qd | 6 | |
| Overall Study | STARTED | 200 mg qd | 3 | |
| Overall Study | COMPLETED | 10 mg Bid | 14 | |
| Overall Study | COMPLETED | 15 mg Bid | 26 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,025
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 | 10 mg Bid | 14 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | 15 mg Bid | 14 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | 25 mg Bid | 27 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | 50 mg Bid | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | All QD | 18 | 37 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 10 mg Bid | 12 | 30 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 15 mg Bid | 11 | 35 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 25 mg Bid | 29 | 47 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 50 mg Bid | 4 | 5 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | All QD | 14 | 37 |
1 to 10 of 1,025Source ClinicalTrials.gov
See all 1,025 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 10 mg Bid | ||
| Total, all-cause mortality | 15 mg Bid | ||
| Total, all-cause mortality | 25 mg Bid | ||
| Total, all-cause mortality | 50 mg Bid | ||
| Total, all-cause mortality | All QD | ||
| Total, other adverse events | 10 mg Bid | 29 | 30 |
| Total, other adverse events | 15 mg Bid | 35 | 35 |
| Total, other adverse events | 25 mg Bid | 47 | 47 |
| Total, other adverse events | 50 mg Bid | 5 | 5 |
| Total, other adverse events | All QD | 36 | 37 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00509899
GET https://conductscience.org/api/trials/v1/NCT00509899/results?page=2