Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT02120417
Recruitment Status : Terminated (The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.)
First Posted : April 22, 2014
Results First Posted : July 12, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE April 18, 2014
First Posted Date  ICMJE April 22, 2014
Results First Submitted Date  ICMJE February 6, 2017
Results First Posted Date  ICMJE July 12, 2017
Last Update Posted Date February 13, 2018
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • Overall Survival (OS) [ Time Frame: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016. ]
    Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.
  • Median Survival [ Time Frame: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016. ]
    Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
  • 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. ]
    Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2014)
Overall Survival (OS) [ Time Frame: Randomization until death due to any cause. Approximately 29 months. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • 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. ]
    Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.
  • Percentage of Participants Achieving Objective Response Rate [ Time Frame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016. ]
    Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
  • Duration of Response (DOR) [ Time Frame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016. ]
    The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
  • Percentage of Participants Achieving Clinical Benefit Rate [ Time Frame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016. ]
    Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2014)
  • Progression-free Survival (PFS) [ Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 29 months. ]
    PFS is defined as the time from randomization through until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1)., or death due to any cause if sooner.
  • Objective Response Rate [ Time Frame: Baseline through end of study. Approximately 29 months. ]
    Objective Response Rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment.
  • Clinical Benefit Rate [ Time Frame: Baseline through end of study. Approximately 29 months. ]
    Clinical benefit rate defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasts for ≥ 6 months.
  • Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments. [ Time Frame: Baseline through approximately 30 days post treatment discontinuation. Approximately 29 months. ]
  • Duration of Response [ Time Frame: Baseline through end of study. Approximately 29 months. ]
    Duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
Official Title  ICMJE A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer
Brief Summary This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Ruxolitinib

    5 mg tablets to be administered by mouth

    Ruxolitinib 15 mg BID (starting dose)

    Other Names:
    • Jakafi ®
    • Jakavi ®
  • Drug: Capecitabine
    Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle
  • Drug: Placebo
    5 mg matching placebo tablets to be administered by mouth
Study Arms  ICMJE
  • Experimental: Treatment A - Capecitabine and ruxolitinib
    Interventions:
    • Drug: Ruxolitinib
    • Drug: Capecitabine
  • Active Comparator: Treatment B - Capecitabine and placebo
    Interventions:
    • Drug: Capecitabine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 10, 2017)
149
Original Estimated Enrollment  ICMJE
 (submitted: April 18, 2014)
148
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
  • Locally advanced (Stage 3B) or metastatic (Stage 4) disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
  • Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
  • ≥ 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
  • Radiographically measurable or evaluable disease
  • An mGPS of 1 or 2 as defined below:

    • Criteria:

      1. modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
      2. mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L

Exclusion Criteria:

  • Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
  • Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
  • Unknown hormone-receptor status
  • Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
  • Concurrent anticancer therapy
  • Inadequate renal, hepatic or bone marrow function
  • Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Portugal,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02120417
Other Study ID Numbers  ICMJE INCB 18424-268
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gerard Kennealey, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP