Trial · NCT01340651
Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients
NCT01340651, Phase 2, Completed, Incyte Corporation; results first posted 2013-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients. Trials, record NCT01340651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01340651
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients
- NCT number
- NCT01340651
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Myelofibrosis
- Interventions
- Ruxolitinib
- First posted
- 2011-04-22
- Last updated
- 2014-03-10
- Results first posted
- 2013-09-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16 | Baseline to Week 16 | |
| Primary | Overall Response (OR) at Week 16 | Baseline to Week 16 | The investigator graded OR according to the International Working Group for Myelofibrosis Research and Therapy criteria for treatment response. As bone marrow biopsies were not taken after baseline, the best achievable response was clinical improvement which required 1 of the following in the absence of progressive disease (PD): (1) A ≥ 2 g/dL increase in hemoglobin level or (2) either a palpable ≥ 50% reduction of splenomegaly of a spleen ≥ 10 cm at baseline or a spleen palpable at \> 5 cm at baseline becoming not palpable. PD required 1 of the following: (1) Progressive splenomegaly defined by the appearance of previously absent splenomegaly that was palpable at \> 5 cm below the left costal margin or a ≥ 100% increase in palpable distance for baseline splenomegaly of 5-10 cm or a ≥ 50% increase in palpable distance for baseline splenomegaly of \> 10 cm or (2) an increase in peripheral blood blast percentage to ≥ 20% that lasted for ≥ 8 weeks. Stable disease: None of the above. |
| Secondary | Change From Baseline in Spleen Volume at Week 16 | Baseline to Week 16 | Spleen volume was measured by magnetic resonance imaging (or by computed tomography \[CT\] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. |
| Secondary | Change From Baseline in Spleen Length at Week 16 | Baseline to Week 16 | Spleen length was measured in centimeters by palpation. |
| Secondary | Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline | Baseline to Week 16 | Spleen volume was measured by magnetic resonance imaging (or by computed tomography \[CT\] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. |
| Secondary | Change From Baseline in the Total Symptom Score at Week 16 | Baseline to Week 16 | Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness \[early satiety\], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms. A negative change score indicated improvement. |
| Secondary | Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16 | Baseline to Week 16 | Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness \[early satiety\], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1 | Day 1 | Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard non-compartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Cmax was taken directly from the observed plasma concentration data. |
| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) of Ruxolitinib 25 mg SR on Day 1 | Day 1 | Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard noncompartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Tmax was taken directly from the observed plasma concentration data. |
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) of Ruxolitinib 25 mg SR on Day 1 | Day 1 | Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. The area under the plasma concentration-time curve (AUC) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule for increasing concentrations and the log-trapezoidal rule for decreasing concentrations with the software WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16 | Baseline to Week 16 | Safety population: All enrolled participants who took at least 1 dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Overall Response (OR) at Week 16 | Baseline to Week 16 | Intent-to-treat population: All enrolled participants. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Spleen Volume at Week 16 | Baseline to Week 16 | Intent-to-treat population: All enrolled participants. | Percentage change | MEAN |
| SECONDARY | Change From Baseline in Spleen Length at Week 16 | Baseline to Week 16 | Intent-to-treat population: All enrolled participants. | Percentage change | MEAN |
| SECONDARY | Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline | Baseline to Week 16 | Intent-to-treat population: All enrolled participants. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Total Symptom Score at Week 16 | Baseline to Week 16 | Intent-to-treat population: All enrolled participants. | Percentage change | MEAN |
| SECONDARY | Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16 | Baseline to Week 16 | Intent-to-treat population: All enrolled participants. | Percentage of participants | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1 | Day 1 | Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample. | nM | MEAN |
| SECONDARY | Time to Reach the Maximum Plasma Concentration (Tmax) of Ruxolitinib 25 mg SR on Day 1 | Day 1 | Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample. | h | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve (AUC) of Ruxolitinib 25 mg SR on Day 1 | Day 1 | Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample. | nM*h | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16 | Ruxolitinib | 78.0 | Percentage of participants | ||
| Overall Response (OR) at Week 16 | Ruxolitinib | Clinical improvement | 17.1 | Percentage of participants | |
| Overall Response (OR) at Week 16 | Ruxolitinib | Stable disease | 80.5 | Percentage of participants | |
| Overall Response (OR) at Week 16 | Ruxolitinib | Progressive disease | 2.4 | Percentage of participants | |
| Change From Baseline in Spleen Volume at Week 16 | Ruxolitinib | -22.3 | Standard Deviation 20.79 | Percentage change | |
| Change From Baseline in Spleen Length at Week 16 | Ruxolitinib | -29.6 | Standard Deviation 34.38 | Percentage change | |
| Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline | Ruxolitinib | 26.8 | 95% Confidence Interval 14.2 to 42.9 | Percentage of participants | |
| Change From Baseline in the Total Symptom Score at Week 16 | Ruxolitinib | -50.4 | Standard Deviation 31.16 | Percentage change | |
| Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16 | Ruxolitinib | 43.9 | 95% Confidence Interval 28.5 to 60.3 | Percentage of participants | |
| Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1 | Ruxolitinib | 319 | Standard Deviation 119 | nM |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ruxolitinib | 41 | |
| Overall Study | COMPLETED | Ruxolitinib | 24 | |
| Overall Study | NOT COMPLETED | Ruxolitinib | 17 |
Source ClinicalTrials.gov
Adverse events66
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 | Diarrhoea | Gastrointestinal disorders | Ruxolitinib - Weeks 1-16 | 8 | 41 | |
| other | Diarrhoea | Gastrointestinal disorders | Ruxolitinib - After Week 16 | 4 | 41 | |
| other | Nausea | Gastrointestinal disorders | Ruxolitinib - Weeks 1-16 | 3 | 41 | |
| other | Nausea | Gastrointestinal disorders | Ruxolitinib - After Week 16 | 0 | 41 | |
| other | Oedema peripheral | General disorders | Ruxolitinib - Weeks 1-16 | 7 | 41 | |
| other | Oedema peripheral | General disorders | Ruxolitinib - After Week 16 | 0 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ruxolitinib - Weeks 1-16 | 7 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ruxolitinib - After Week 16 | 0 | 41 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Ruxolitinib - Weeks 1-16 | 4 | 41 | |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Ruxolitinib - After Week 16 | 0 | 41 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib - Weeks 1-16 | ||
| Total, all-cause mortality | Ruxolitinib - After Week 16 | ||
| Total, other adverse events | Ruxolitinib - Weeks 1-16 | 27 | 41 |
| Total, other adverse events | Ruxolitinib - After Week 16 | 9 | 41 |
| Total, serious adverse events | Ruxolitinib - Weeks 1-16 | 6 | 41 |
| Total, serious adverse events | Ruxolitinib - After Week 16 | 9 | 41 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ruxolitinib - Weeks 1-16 vs Ruxolitinib - After Week 16: serious adverse events |
Source Trial comparisons
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/NCT01340651
GET https://conductscience.org/api/trials/v1/NCT01340651/events?page=2