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

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ClinicalTrials.gov Identifier: NCT02087059
Recruitment Status : Completed
First Posted : March 14, 2014
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Primary Myelofibrosis (MF)
Intervention: Drug: Ruxolitinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ruxolitinib Ruxolitinib 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.

Participant Flow:   Overall Study
    Ruxolitinib
STARTED   51 
COMPLETED   44 
NOT COMPLETED   7 
Disease Progression                1 
Adverse Event                5 
Lost to Follow-up                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ruxolitinib Ruxolitinib 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.

Baseline Measures
   Ruxolitinib 
Overall Participants Analyzed 
[Units: Participants]
 51 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.7  (8.8) 
Gender 
[Units: Participants]
 
Female   24 
Male   27 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 24 weeks ]

2.  Secondary:   Charge in Spleen Size From Baseline at Specified Week   [ Time Frame: Baseline, 24 weeks ]

3.  Secondary:   Charge in Spleen Size From Baseline up to the Specified Week   [ Time Frame: Baseline, 24 weeks ]

4.  Secondary:   Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time   [ Time Frame: 24 weeks ]

5.  Secondary:   Summary of Summary of EORTC QLQ-C30 Responses by Time   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02087059     History of Changes
Other Study ID Numbers: CINC424AJP01
First Submitted: March 12, 2014
First Posted: March 14, 2014
Results First Submitted: April 11, 2016
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016