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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02120417
First received: April 18, 2014
Last updated: March 3, 2016
Last verified: March 2016
  Purpose
This is a randomized, double-blind, placebo controlled clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who receive treatment with capecitabine in combination with ruxolitinib versus those who receive 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 Blind (Subject, 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. Approximately 29 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 29 months. ] [ Designated as safety issue: No ]
    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: Randomization through end of study. Approximately 29 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
  • Duration of Response [ Time Frame: Baseline through end of study. Approximately 29 months. ] [ Designated as safety issue: No ]
    Duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment


Estimated Enrollment: 148
Study Start Date: March 2014
Estimated Study Completion Date: October 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 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 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
Genders 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
  • Subjects with hormone-receptor positive tumors must have failed available appropriate lines of hormonal therapy
  • ≥ 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. mGPS of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
      2. mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L

Exclusion Criteria:

  • Received prior treatment with capecitabine for metastatic disease
  • Received more than 2 prior chemotherapy regimens for advanced or metastatic disease (not including neoadjuvant/adjuvant therapy)
  • Unknown hormone-receptor status
  • Ongoing radiation therapy, radiation therapy administered within 2 weeks of enrollment
  • Inadequate renal, hepatic or bone marrow function
  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

  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, District of Columbia, United States
United States, Florida
Ft Myers, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
St. 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
St. 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
Bronx, New York, United States
Johnson City, New York, United States
New York, 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
Ft 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, 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
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
Last Updated: March 3, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016