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

NCT02120417 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2018-02-13

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Ruxolitinib

5 mg tablets to be administered by mouth Ruxolitinib 15 mg BID (starting dose)

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

Sponsors & Collaborators

Principal Investigators

  • Gerard Kennealey, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-02-29
Completion
2017-01-31

Countries

  • United States
  • France
  • Italy
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120417 on ClinicalTrials.gov