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NCT01348490 · ClinicalTrials.gov registry record · Phase 2

Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)

A Phase 2 study, sponsored by Incyte Corporation.

Completed
Registry status
Phase 2
Development phase
66
Enrollment target

NCT01348490: Completed Phase 2 study, sponsored by Incyte Corporation.

NCT01348490 is a Phase 2 study that has completed, run by Incyte Corporation. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01348490, a Phase 2 study, has completed, sponsored by Incyte Corporation.

COMPLETED
Registry status
Phase 2
Development phase
66 participants
Enrollment target

Study Summary

To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10\^9/L to 100 x 10\^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.

Primary Outcome

Magnetic resonance imaging (MRI) of the upper and lower abdomen and pelvis was performed to assess spleen volumes. Computed tomography (CT) scan was performed if participant was not a candidate for MRI or if MRI was not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or s

Interventions

  • DRUG Ruxolitinib

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2011-06-15
Est. Completion 2018-12-19
Phase Phase 2
Incyte Corporation

239 total trials

What the finished NCT01348490 record still lists

NCT01348490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which Ruxolitinib is the first listed.

NCT01348490 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01348490 about?

NCT01348490 is a clinical study titled "Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)". To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10\^9/L to 100 x 10\^9/L. It is anticipated that individualized dose optimization from the starting ru...

What is the current status of trial NCT01348490?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2011-06-15. Estimated completion is 2018-12-19.

What interventions are being tested in trial NCT01348490?

The interventions under investigation include: Ruxolitinib (DRUG).

Who is sponsoring clinical trial NCT01348490?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01348490's enrollment target sits among peer trials

66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01348490, the US trial registry maintained by the National Library of Medicine. NCT01348490 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.