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Primary Myelofibrosis (MF)Phase 3NCT02087059

A Clinical Study of Ruxolitinib in Patients With Primary Myelofibrosis (PM), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis

A Phase 3 study testing Ruxolitinib in people with Primary Myelofibrosis (MF), run by Novartis Pharmaceuticals at 29 sites in Japan.

Completed

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

Official record
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Trial summary

This is an open-label, multicenter clinical study in order to collect and examine data concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Myelofibrosis (MF)
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
51 participants
Where
29 sitesJapan
Study dates
Apr 2014to Apr 2015
Phase
Phase 3
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

  • ≥18 years of age
  • Diagnosis of PMF, PPV-MF, or PET-MF, regardless of JAK2 mutational status. The diagnostic of PMF will be according to the World Health Organization (WHO) criteria (Thiele et al., 2008) and PPV-MF and PET-MF according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria (Barosi et al., 2008).
  • At least one risk factors provided in the definition of IWG-MRT (Cervantes et al., 2009; classified as intermediate risk-1, intermediate risk-2, or high risk)
  • Patients with intermediate risk-1 (patients who have only one of the IMG-MRT risk factors indicated above ) must have palpable splenomegaly with a length of ≥5 cm from the costal margin to the point of the greatest spleen protrusion.
  • Proportion of blasts in peripheral blood <10%
  • ECOG performance status of 0 to 2
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  • The following values for bone marrow function prior to treatment:
  • Absolute neutrophil count ≥1,000/μL, and
  • Platelet count ≥50,000/μL without administration of a growth factor, thrombopoietin, or platelet transfusion
  • Stem cell transplantation is not a treatment option at present because it is not indicated or because there are no suitable donors.
  • All drugs used to treat MF were discontinued at least 28 days before treatment initiation.
  • Informed consent form should be signed before any screening procedures is performed

Who cannot join

  • Hepatic or renal impairment as indicated by the following:
  • Direct bilirubin ≥2-fold than the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) >2.5-fold ULN
  • Creatinine >2.0 mg/dL
  • Clinically significant infection by bacteria, fungus, mycobacteria, parasite, or virus (screening and enrollment postponed until completion of antibiotic treatment in patients with an acute bacterial infection that requires antibiotic use)
  • Active hepatitis A, B, or C or HIV infection defined by a positive IgM-HA Ab test [hepatitis A virus antibody (immunoglobulin M [IgM])], HBs Ag test (hepatitis B surface antigen), HCV Ab test (hepatitis C virus antibody), or HIV Ab (human immunodeficiency virus antibody) at screening.
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  • History of malignancy within the previous 3 years, except for early-stage squamous cell carcinoma and basal cell carcinoma.
  • History of serious congenital or acquired hemorrhagic disease
  • Previous platelet count <25,000/μL or absolute neutrophil count <500/μL, except for patients currently undergoing treatment for a myeloproliferative neoplasm or cytotoxic therapy for any other reason.
  • Splenic irradiation within 12 months before screening
  • Administration of hematopoietic growth factor receptor agonists (erythropoietin, granulocyte colony stimulating factor, romiplostim, eltrombopag) within 14 days before screening or 28 days before treatment initiation.
  • Currently receiving another investigational drug, or received another investigational drug within 30 days before the start of treatment.
  • History of myocardial infarction or acute coronary syndrome within 6 months before screening
  • Poorly controlled or unstable angina at present
  • Rapid or paroxysmal atrial fibrillation at present
  • Active alcohol or drug addiction that could hinder the patient's ability to comply with the study's requirements
  • Pregnant or currently breastfeeding woman
  • Women of childbearing potential or men with reproductive ability who are unwilling to take appropriate contraception measures
  • Patient with any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
  • History of hypersensitivity to the study drug or a drug with a similar chemical structure

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Japan29 sites

  • Novartis Investigative Site

    Akita, Akita, 010-8543

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8519

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8603

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8677

  • Novartis Investigative Site

    Chūō, Yamanashi, 409-3898

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Gifu, Gifu, 501-1194

  • Novartis Investigative Site

    Hirakata, Osaka, 573-1191

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0017

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0047

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011

  • Novartis Investigative Site

    Kyoto, Kyoto, 606-8507

  • Novartis Investigative Site

    Maebashi, Gunma, 371-8511

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-8524

  • Novartis Investigative Site

    Miyazaki, Miyazaki, 889-1692

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 467-8602

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8558

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8543

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Sayama, Osaka, 589-8511

  • Novartis Investigative Site

    Sendai, Miyagi, 980-8574

  • Novartis Investigative Site

    Shimotsuke, Tochigi, 329-0498

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160-0023

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 162-8666

  • Novartis Investigative Site

    Suita, Osaka, 565-0871

  • Novartis Investigative Site

    Tōon, Ehime, 791-0295

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-8507

Other trials in Japan

About this study

Official title: A Multicenter, Open-label Clinical Study of the JAK Inhibitor Ruxolitinib (INC424) in Patients With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis

This is an open-label, multicenter clinical study in order to collect and examine data concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.

Being tested
Ruxolitinib
Keywords
Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF
Medical subject headings
Primary Myelofibrosis

What participants receive

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

Study groups in NCT02087059
Study groupRoleWhat they receive
RuxolitinibExperimentalRuxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
Receives: Drug: Ruxolitinib

What is being measured

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

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Measured: 24 weeks

Secondary outcomes (4)

  1. Charge in Spleen Size From Baseline at Specified Week

    Number of patients with spleen length reduced by ≥ 50% at specified week

    Measured: Baseline, 24 weeks

  2. Charge in Spleen Size From Baseline up to the Specified Week

    Number of patients with spleen length reduced by ≥ 50% up to specified week

    Measured: Baseline, 24 weeks

  3. Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time

    The modified MFSAF v2.0 diary captures a patient's symptom severity on a scale of 0 (absent) to 10 (worst imaginable),with a maximal summary score of 60

    Measured: 24 weeks

  4. Summary of Summary of EORTC QLQ-C30 Responses by Time

    The QLQ-C30 version 1.0 (QLQ-C30) incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: 24 weeks

Timeline

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

  1. First posted14 Mar 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionMar 2015
  4. Study completionApr 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02087059
Sponsor's protocol ID
CINC424AJP01
Status last verified
May 2016
First submitted
12 Mar 2014
Last updated
11 Jul 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ruxolitinib in people with Primary Myelofibrosis (MF), run by Novartis Pharmaceuticals at 29 sites in Japan.

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 12 inclusion and 20 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Japan. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 11 Jul 2016). 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 as a Measure of Safety and Tolerability (time frame: 24 weeks). 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 NCT02087059.

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 11 Jul 2016.

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