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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
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120417


  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Chandler, Arizona, United States
Sedona, Arizona, United States
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
United States, Colorado
Aurora, Colorado, United States
Denver, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, District of Columbia
Washington, D.C., District of Columbia, United States
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
United States, Georgia
Atlanta, Georgia, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Quincy, Illinois, United States
Springfield, Illinois, United States
Urbana, Illinois, United States
United States, Iowa
Ames, Iowa, United States
United States, Kansas
Wichita, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Michigan
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
United States, Minnesota
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
United States, Nebraska
Grand Island, Nebraska, United States
Omaha, Nebraska, United States
United States, New Jersey
Camden, New Jersey, United States
Hackensack, New Jersey, United States
United States, New Mexico
Farmington, New Mexico, United States
United States, New York
Albany, New York, United States
Johnson City, New York, United States
New York, New York, United States
The Bronx, New York, United States
United States, North Carolina
Goldsboro, North Carolina, United States
Pinehurst, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Middletown, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Greenville, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
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
United States, Utah
Ogden, Utah, United States
Salt Lake City, Utah, United States
United States, Virginia
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Salem, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Green Bay, Wisconsin, United States
Milwaukee, Wisconsin, United States
France
La Roche Sur Yon, France
Paris Cedex 10, France
Paris, 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
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
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
Last Verified: July 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