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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00952289
First received: August 4, 2009
Last updated: May 13, 2013
Last verified: May 2013
Results First Received: December 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Myelofibrosis
Interventions: Drug: Ruxolitinib
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ruxolitinib Participants received ruxolitinib orally twice a day. The starting dose was based on Baseline platelet count. Patients with Baseline platelet count > 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
Placebo Placebo tablets matching ruxolitinib administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to crossover to ruxolitinib treatment.

Participant Flow for 2 periods

Period 1:   All Participants
    Ruxolitinib     Placebo  
STARTED     155     154  
Safety Population     155     151 [1]
COMPLETED     134 [2]   114 [3]
NOT COMPLETED     21     40  
Death                 9                 9  
Adverse Event                 8                 8  
Disease progression                 3                 12  
Withdrawal by Subject                 1                 10  
Data lost during site relocation                 0                 1  
[1] Randomized patients who are documented to have received at least 1 dose of study medication.
[2] Represents the number of patients who were still in the study as of 02 November 2010
[3] Includes patients in the study as of 2 November 2010 (78) + those who crossed over to Ruxolitinib.

Period 2:   Patients Who Crossed Over to Ruxolitinib
    Ruxolitinib     Placebo  
STARTED     0     36  
COMPLETED     0     32 [1]
NOT COMPLETED     0     4  
Death                 0                 1  
Withdrawal by Subject                 0                 1  
Non-compliance to study medication                 0                 1  
Physician Decision                 0                 1  
[1] Number of crossover patients who were still in the study as of 02 November 2010



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib   [ Time Frame: Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months). ]

3.  Secondary:   Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib   [ Time Frame: Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months). ]

4.  Secondary:   Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24   [ Time Frame: Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit. ]

5.  Secondary:   Change From Baseline to Week 24 in Total Symptom Score   [ Time Frame: Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit. ]

6.  Secondary:   Overall Survival   [ Time Frame: From randomization to the data cut-off date (up to 14 months). ]

7.  Secondary:   Overall Survival Time   [ Time Frame: From randomization to the data cut-off date (up to 14 months). ]

8.  Secondary:   Overall Survival - Extended Data   [ Time Frame: From randomization to 4 months after the data cut-off date (up to 18 months). ]

9.  Secondary:   Overall Survival Time - Extended Data   [ Time Frame: From randomization to 4 months after the data cut-off date (up to 18 months). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information