Trial Search Results

COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial

This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Incyte Corporation

Intervention(s):

  • Drug: Ruxolitinib
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia
   vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF)
   according to the 2008 World Health Organization criteria

   - Subjects with myelofibrosis requiring therapy must be classified as high risk OR
   intermediate risk level 2 according to the prognostic factors defined by the
   International Working Group

   - Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1,
   2 or 3

   - Subjects who have not previously received treatment with a Janus kinase (JAK)
   inhibitor

Exclusion Criteria:

   - Subjects with a life expectancy of less than 6 months

   - Subjects with inadequate bone marrow reserve as demonstrated by specific clinical
   laboratory counts

   - Subjects with inadequate liver or renal function

   - Subjects with clinically significant bacterial, fungal, parasitic or viral infection
   which require therapy

   - Subjects with an active malignancy over the previous 5 years except specific skin
   cancers.

   - Subjects with severe cardiac conditions

   - Subjects who have had splenic irradiation within 12 months

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting