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
  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: 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


Estimated Enrollment: 148
Study Start Date: March 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: August 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)
Active Comparator: Treatment B - Capecitabine and placebo 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

  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

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
  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

Contacts
Contact: Incyte Corporation Call Center 1-855-463-3463

  Show 25 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Gerard Kennealey, MD Incyte Corporation
  More Information

No publications provided

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: April 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Breast Cancer

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

ClinicalTrials.gov processed this record on August 19, 2014