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A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

This study has been terminated.
(The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02120417
First Posted: April 22, 2014
Last Update Posted: July 12, 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.
Information provided by (Responsible Party):
Incyte Corporation
Results First Submitted: February 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Advanced or Metastatic HER2-negative Breast Cancer
Interventions: Drug: Ruxolitinib
Drug: Capecitabine
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
This study was conducted at 72 study centers (65 in the United States and 7 in the European Union [3 in the United Kingdom, 3 in Spain, and 1 in Portugal]).

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
Treatment A - Capecitabine and Ruxolitinib Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Treatment B - Capecitabine and Placebo Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle

Participant Flow:   Overall Study
    Treatment A - Capecitabine and Ruxolitinib   Treatment B - Capecitabine and Placebo
STARTED [1]   76   73 
COMPLETED [2]   16   5 
NOT COMPLETED   60   68 
Death                5                1 
Adverse Event                3                9 
Participant decision                4                4 
Disease progression                41                45 
Noncompliance with study treatment                0                2 
Physician Decision                2                3 
Other unspecified                5                4 
[1] Overall Number of Participants Analyzed
[2] Number of participants remaining on treatment at the 08 FEB 2016 data cutoff.



  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.
The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.

Reporting Groups
  Description
Treatment A - Capecitabine and Ruxolitinib Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Treatment B - Capecitabine and Placebo Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Total Total of all reporting groups

Baseline Measures
   Treatment A - Capecitabine and Ruxolitinib   Treatment B - Capecitabine and Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 76   73   149 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (11.00)   55.0  (12.75)   54.6  (11.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      76 100.0%      73 100.0%      149 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016. ]

2.  Primary:   Median Survival   [ Time Frame: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016. ]

3.  Primary:   Percentage of Participants Achieving Overall Survival   [ Time Frame: Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016. ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016. ]

5.  Secondary:   Percentage of Participants Achieving Objective Response Rate   [ Time Frame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016. ]

6.  Secondary:   Duration of Response (DOR)   [ Time Frame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016. ]

7.  Secondary:   Percentage of Participants Achieving Clinical Benefit Rate   [ Time Frame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016. ]


  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:  
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: Study Director
Organization: Incyte Corporation
phone: 855 463-3463



Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02120417     History of Changes
Other Study ID Numbers: INCB 18424-268
First Submitted: April 18, 2014
First Posted: April 22, 2014
Results First Submitted: February 6, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017