Trials / Terminated
TerminatedNCT02120417
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2016-02-01
- Completion
- 2017-01-01
- First posted
- 2014-04-22
- Last updated
- 2018-02-13
- Results posted
- 2017-07-12
Locations
106 sites across 6 countries: United States, France, Italy, Portugal, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02120417. Inclusion in this directory is not an endorsement.