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

January 15, 2018 updated by: Incyte Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche Sur Yon, France
      • Paris, France
      • Paris Cedex 10, France
  • Italy
      • Alba, Italy
      • Fano, Italy
      • Foggia, Italy
      • Lecco, Italy
      • Milano, Italy
      • Naples, Italy
      • Pontedera, Italy
      • Roma, Italy
      • Saronno, Italy
  • Portugal
      • Lisbon, Portugal
  • Spain
      • A Coruña, Spain
      • Barcelona, Spain
      • Jaén, Spain
      • Lleida, Spain
      • Madrid, Spain
  • United Kingdom
      • Cardiff, United Kingdom
      • Glasgow, United Kingdom
      • Kingston Upon Thames, United Kingdom
      • London, United Kingdom
      • Nottingham, United Kingdom
      • Sutton, United Kingdom
      • Taunton, United Kingdom
      • Truro, United Kingdom
      • Yeovil, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Sedona, Arizona, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Oxnard, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Santa Monica, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Denver, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Fort Myers, Florida, United States
      • Hialeah, Florida, United States
      • Miami, Florida, United States
      • Plantation, Florida, United States
      • Saint Petersburg, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Marietta, Georgia, United States
      • Savannah, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Quincy, Illinois, United States
      • Springfield, Illinois, United States
      • Urbana, Illinois, United States
    • Iowa
      • Ames, Iowa, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Michigan
      • Detroit, Michigan, United States
      • Kalamazoo, Michigan, United States
    • Minnesota
      • Duluth, Minnesota, United States
      • Minneapolis, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Grand Island, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Jersey
      • Camden, New Jersey, United States
      • Hackensack, New Jersey, United States
    • New Mexico
      • Farmington, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Bronx, New York, United States
      • Johnson City, New York, United States
      • New York, New York, United States
    • North Carolina
      • Goldsboro, North Carolina, United States
      • Pinehurst, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Middletown, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Greenville, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Bedford, Texas, United States
      • Dallas, Texas, United States
      • El Paso, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • McAllen, Texas, United States
      • Plano, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Salem, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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.
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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.
Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
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.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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.
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Gerard Kennealey, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

January 15, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 18424-268

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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