Clinical Trials /

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

NCT02120417

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: INCB 18424-268
  • NCT ID: NCT02120417

Conditions

  • Advanced or Metastatic HER2-negative Breast Cancer

Interventions

DrugSynonymsArms
RuxolitinibJakafi ®, Jakavi ®Treatment A - Capecitabine and ruxolitinib
CapecitabineTreatment A - Capecitabine and ruxolitinib
PlaceboTreatment B - Capecitabine and placebo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment A - Capecitabine and ruxolitinibExperimental
  • Ruxolitinib
  • Capecitabine
Treatment B - Capecitabine and placeboActive Comparator
  • Capecitabine
  • Placebo

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure: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.
Safety Issue:
Description: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.
Measure:Percentage of Participants Achieving Objective Response Rate
Time Frame:Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Safety Issue:
Description: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.
Measure:Duration of Response (DOR)
Time Frame:Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Safety Issue:
Description: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.
Measure:Percentage of Participants Achieving Clinical Benefit Rate
Time Frame:Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Breast Cancer

Last Updated

July 10, 2017