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Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732445
First Posted: November 22, 2012
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
Results First Submitted: August 4, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Anemia
Primary Myelofibrosis
Secondary Myelofibrosis
Interventions: Drug: ruxolitinib phosphate
Drug: danazol
Other: quality-of-life assessment
Other: questionnaire administration

  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
No text entered.

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
Supportive Care (Ruxolitinib Phosphate and Danazol) Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.

Participant Flow:   Overall Study
    Supportive Care (Ruxolitinib Phosphate and Danazol)
STARTED   14 
COMPLETED   14 
NOT COMPLETED   0 



  Baseline Characteristics
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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
Supportive Care (Ruxolitinib Phosphate and Danazol) Patients receive ruxolitinib phosphate PO 10 mg BID and danazol PO 200 mg TID on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician’s discretion, patients may continue treatment past 6 courses if they are without disease progression.

Baseline Measures
   Supportive Care (Ruxolitinib Phosphate and Danazol) 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Median (Full Range)
 70.5 
 (43 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  35.7% 
Male      9  64.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   14 


  Outcome Measures
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1.  Primary:   Best Overall Response Rate as Determined by International Working Group Criteria   [ Time Frame: Up to 2 years ]

2.  Secondary:   Survival Time   [ Time Frame: From registration to death due to any cause, assessed up to 2 years ]

3.  Secondary:   Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)   [ Time Frame: Up to 2 years ]

4.  Other Pre-specified:   Patient-reported Symptoms Assessed Using the MPN-SAF, as Measured by the Percentage of Patients With a Decrease in MPN-SAF TSS Greater Than 50% From Baseline   [ Time Frame: Baseline to up to 2 years ]


  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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ruben A. Mesa, M.D.
Organization: Mayo Clinic
phone: 480/301-8335
e-mail: mesa.ruben@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01732445     History of Changes
Other Study ID Numbers: MC1283
NCI-2012-02201 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1283 ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2012
First Posted: November 22, 2012
Results First Submitted: August 4, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017