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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:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02120417
First received: April 18, 2014
Last updated: July 10, 2017
Last verified: July 2017
  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.

Condition Intervention Phase
Advanced or Metastatic HER2-negative Breast Cancer Drug: Ruxolitinib Drug: Capecitabine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 149
Actual Study Start Date: May 2014
Study Completion Date: January 2017
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A - Capecitabine and ruxolitinib 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
Active Comparator: Treatment B - Capecitabine and placebo 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02120417

  Show 107 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Gerard Kennealey, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02120417     History of Changes
Other Study ID Numbers: INCB 18424-268
Study First Received: April 18, 2014
Results First Received: February 6, 2017
Last Updated: July 10, 2017

Keywords provided by Incyte Corporation:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2017