MyelofibrosisPhase 1/2NCT00509899

Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis

A Phase 1/2 study testing Ruxolitinib in people with Myelofibrosis and Polycythemia Vera, run by Incyte Corporation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424), administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myelofibrosis, Polycythemia Vera, Thrombocytosis
What is being tested?: Ruxolitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 2 sitesUnited States
Study dates: Jun 2007to Feb 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with PMF or Post-PV/ET MF
Patients with myelofibrosis requiring therapy
Adequate bone marrow reserve

Who cannot join

Received anti-cancer medications or investigational therapy in the past 14 days

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
Houston, Texas
Study site
Rochester, Minnesota

Other trials in United States

About this study

Official title: A Phase 1/2, Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)

Read the detailed description

This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF, PPEV-MF or PET-MF. The study is comprised of 3 parts:

Part 1: Dose escalation and determination of maximum tolerated dose (complete).

Part 2: Exploration of alternative dosing schedules (complete).

Part 3: Further evaluation of selected dose regimens, including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival (ongoing).

Conditions: Myelofibrosis, Polycythemia Vera, Thrombocytosis
Being tested: Ruxolitinib
Medical subject headings: Primary Myelofibrosis, Polycythemia Vera, Thrombocytosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RuxolitinibDrug
Also called INCB018424, Jakafi(TM)
5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.

Study groups in NCT00509899
Study group	Role	What they receive
Ruxolitinib	Experimental	All participants received oral ruxolitinib. Patients began treatment with either 10 mg twice a day (bid), 15 mg bid, 25 mg bid, 50 mg bid, 25 mg once a day (qd), 50 mg qd, 100 mg qd, or 200 mg qd, depending on the time period when they entered the study. The doses were titrated based on efficacy and safety to a maximum of 25 mg bid for patients who entered the study after sufficient dosing information had been obtained to define the maximum dose for patients in the study. Patients could continue receiving treatment indefinitely if receiving benefit at a dose that continues to maintain benefit but does not exceed a maximum dose of 25 mg BID. Receives: Drug: Ruxolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs)
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.
Measured: 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.
Percentage of Participants With Clinical Improvement (CI) Over Time
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.
Measured: Week 12, 24, 36, 48 and 60

Secondary outcomes (6)

Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time
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.
Measured: Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60
Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time
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.
Measured: Baseline, Weeks 4, 12, 24 and 48
Change From Baseline in Myelofibrosis Total Symptom Score at 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.
Measured: Baseline and Week 24
Change From Baseline to Week 24 in Health-Related Quality of Life
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.
Measured: Baseline and Week 24
Change From Baseline in Body Weight Over Time
Measured: Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60.
Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status
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.
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Feb 2017

First posted1 Aug 2007 (estimated)
Study startJun 2007
Primary completionDec 2007
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for MyelofibrosisStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00509899
Sponsor's protocol ID: INCB 18424-251
Status last verified: Feb 2018
First submitted: 30 Jul 2007
Last updated: 12 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Verstovsek S, Kantarjian H, Mesa RA, Pardanani AD, Cortes-Franco J, Thomas DA, Estrov Z, Fridman JS, Bradley EC, Erickson-Viitanen S, Vaddi K, Levy R, Tefferi A. Safety and efficacy of INCB018424, a JAK1 and JAK2 inhibitor, in myelofibrosis. N Engl J Med. 2010 Sep 16;363(12):1117-27. doi: 10.1056/NEJMoa1002028.
PubMed 20843246
Verstovsek S, Kantarjian HM, Estrov Z, Cortes JE, Thomas DA, Kadia T, Pierce S, Jabbour E, Borthakur G, Rumi E, Pungolino E, Morra E, Caramazza D, Cazzola M, Passamonti F. Long-term outcomes of 107 patients with myelofibrosis receiving JAK1/JAK2 inhibitor ruxolitinib: survival advantage in comparison to matched historical controls. Blood. 2012 Aug 9;120(6):1202-9. doi: 10.1182/blood-2012-02-414631. Epub 2012 Jun 20.
PubMed 22718840
Kvasnicka HM, Thiele J, Bueso-Ramos CE, Sun W, Cortes J, Kantarjian HM, Verstovsek S. Long-term effects of ruxolitinib versus best available therapy on bone marrow fibrosis in patients with myelofibrosis. J Hematol Oncol. 2018 Mar 15;11(1):42. doi: 10.1186/s13045-018-0585-5.
PubMed 29544547

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

All Myelofibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)
ClinicalTrials.gov ID: NCT00509899
Acronym / sponsor ID: INCB 18424-251
Conditions: Myelofibrosis, Polycythemia Vera, Thrombocytosis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Dec 2007 (actual)
Study completion: Feb 2017 (actual)
First posted: 1 Aug 2007 (estimated)
Results: Posted 2 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Part 1: Dose escalation and determination of maximum tolerated dose (complete).

Part 2: Exploration of alternative dosing schedules (complete).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ruxolitinib	Experimental	Drug: RuxolitinibAll participants received oral ruxolitinib. Patients began treatment with either 10 mg twice a day (bid), 15 mg bid, 25 mg bid, 50 mg bid, 25 mg once a day (qd), 50 mg qd, 100 mg qd, or 200 mg qd, depending on the time period when they entered the study. The doses were titrated based on efficacy and safety to a maximum of 25 mg bid for patients who entered the study after sufficient dosing information had been obtained to define the maximum dose for patients in the study. Patients could continue receiving treatment indefinitely if receiving benefit at a dose that continues to maintain benefit but does not exceed a maximum dose of 25 mg BID.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosed with PMF or Post-PV/ET MF
Patients with myelofibrosis requiring therapy
Adequate bone marrow reserve

Key exclusion criteria (1 listed)

Received anti-cancer medications or investigational therapy in the past 14 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RuxolitinibAlso: INCB018424, Jakafi(TM)5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.	Drug	Ruxolitinib

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: 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.
Percentage of Participants With Clinical Improvement (CI) Over Time
Time frame: 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.

6 secondary outcomes

Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time
Time frame: Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60
Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time
Time frame: Baseline, Weeks 4, 12, 24 and 48
Change From Baseline in Myelofibrosis Total Symptom Score at Week 24
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in Health-Related Quality of Life
Time frame: Baseline and Week 24
Change From Baseline in Body Weight Over Time
Time frame: Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60.
Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 2 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 mg Bid	30	14
15 mg Bid	35	26
25 mg Bid	47	27
50 mg Bid	5	1
25 mg qd	6	1
50 mg qd	22	12
100 mg qd	6	5
200 mg qd	3	2

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: 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.. Number. Unit: participants

Measure	10 mg Bid n = 30	15 mg Bid n = 35	25 mg Bid n = 47	50 mg Bid n = 5	All QD n = 37
Any Treatment-Emergent Adverse Event	30	35	47	5	37
Treatment-Related Adverse Events	21	22	41	4	29
Serious Adverse Events	8	17	21	2	23
Severe or Life-threatening Adverse Events	21	25	39	3	28
Study Drug Interrupted Due to Adverse Events	9	9	20	3	23
Discontinued Study Drug Due to Adverse Events	6	0	7	2	5
Study Drug Reduced Due to Adverse Events	8	12	26	1	11

Population analysed: Safety population included all patients who received at least 1 dose of study medication.

Primary outcome: Percentage of Participants With Clinical Improvement (CI) Over Time

Time frame: Week 12, 24, 36, 48 and 60. Number. Unit: percentage of participants

Measure	10 mg Bid n = 25	15 mg Bid n = 34	25 mg Bid n = 42	50 mg Bid n = 5	All QD n = 32
12 Weeks [N=25, 34, 42, 5, 32]	36.0	38.2	38.1	40.0	34.4
24 Weeks [N=21, 31, 40, 4, 29]	42.9	51.6	37.5	75.0	37.9
36 Weeks [N=18, 30, 36, 4, 25]	66.7	56.7	38.9	50.0	56.0
48 Weeks [N=17, 28, 36, 3, 23]	47.1	67.9	41.7	33.3	56.5
60 Weeks [N=15, 21, 33, 2, 21]	53.3	66.7	54.5	50.0	61.9

Population analysed: 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.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 mg Bid	8 of 30 (26.7%)	29 of 30 (96.7%)	Not reported
15 mg Bid	17 of 35 (48.6%)	35 of 35 (100%)	Not reported
25 mg Bid	21 of 47 (44.7%)	47 of 47 (100%)	Not reported
50 mg Bid	2 of 5 (40%)	5 of 5 (100%)	Not reported
All QD	23 of 37 (62.2%)	36 of 37 (97.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20843246Verstovsek S, Kantarjian H, Mesa RA, Pardanani AD, Cortes-Franco J, Thomas DA, Estrov Z, Fridman JS, Bradley EC, Erickson-Viitanen S, Vaddi K, Levy R, Tefferi A. Safety and efficacy of INCB018424, a JAK1 and JAK2 inhibitor, in myelofibrosis. N Engl J Med. 2010 Sep 16;363(12):1117-27. doi: 10.1056/NEJMoa1002028.
Results publication: PubMed 22718840Verstovsek S, Kantarjian HM, Estrov Z, Cortes JE, Thomas DA, Kadia T, Pierce S, Jabbour E, Borthakur G, Rumi E, Pungolino E, Morra E, Caramazza D, Cazzola M, Passamonti F. Long-term outcomes of 107 patients with myelofibrosis receiving JAK1/JAK2 inhibitor ruxolitinib: survival advantage in comparison to matched historical controls. Blood. 2012 Aug 9;120(6):1202-9. doi: 10.1182/blood-2012-02-414631. Epub 2012 Jun 20.
Derived from this study: PubMed 29544547Kvasnicka HM, Thiele J, Bueso-Ramos CE, Sun W, Cortes J, Kantarjian HM, Verstovsek S. Long-term effects of ruxolitinib versus best available therapy on bone marrow fibrosis in patients with myelofibrosis. J Hematol Oncol. 2018 Mar 15;11(1):42. doi: 10.1186/s13045-018-0585-5.

Related trials for Myelofibrosis

RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
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RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
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RecruitingPhase 2
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Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Srdan Verstovsek, MD, PhD principal investigator

M.D. Anderson Cancer Center, Houston, TX

Ayalew Tefferi, MD principal investigator

Mayo Clinic, Rochester, MN

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ruxolitinib in people with Myelofibrosis and Polycythemia Vera, run by Incyte Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00509899, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.