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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02120417
First received: April 18, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted

April 18, 2014
April 18, 2014
March 2014
August 2016   (final data collection date for primary outcome measure)
Overall Survival (OS) [ Time Frame: Randomization until death due to any cause. Approximately 29 months. ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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: Baseline 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
Same as current
Not Provided
Not Provided
 
A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
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 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Advanced or Metastatic HER2-negative Breast Cancer
  • 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)
  • Drug: Placebo
    5 mg matching placebo tablets to be administered by mouth
  • Experimental: Treatment A - Capecitabine and ruxolitinib
    Interventions:
    • Drug: Ruxolitinib
    • Drug: Capecitabine
  • Active Comparator: Treatment B - Capecitabine and placebo
    Interventions:
    • Drug: Capecitabine
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
148
November 2016
August 2016   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • Received prior treatment with capecitabine
  • Received more than 2 prior chemotherapy regimens for advanced or metastatic disease (not including neoadjuvant/adjuvant therapy)
  • Unknown hormone-receptor status
  • Bilateral breast cancer or a history of 2 distinct breast cancers
  • Inflammatory breast carcinoma
  • Ongoing radiation therapy, radiation therapy administered within 2 weeks of enrollment, or history of radiation therapy to ≥ 25% of the bone marrow
Female
18 Years and older
No
Contact: Incyte Corporation Call Center 1-855-463-3463
United States
 
NCT02120417
INCB 18424-268
No
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Gerard Kennealey, MD Incyte Corporation
Incyte Corporation
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP