Clinical Trials Directory

Trials / Completed

CompletedNCT00615940

Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer

A Phase 2, Two-arm, Double-blind, Multi-center, Randomized Study of the Combination of Oral WX-671 Plus Capecitabine vs. Capecitabine Monotherapy in First-line Her2-negative Metastatic Breast Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
132 (actual)
Sponsor
Heidelberg Pharma AG · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This randomized, double-blind, placebo controlled phase II trial is studying how well capecitabine works when given in combination with WX-671 or when given alone in treating patients receiving first-line therapy for her2negative metastatic breast cancer.

Conditions

Interventions

TypeNameDescription
DRUGWX-671capsules taken per os once daily until progression or toxicity
DRUGplacebocapsule taken per os once daily until progression or toxicity

Timeline

Start date
2008-07-01
Primary completion
2011-12-01
Completion
2012-04-01
First posted
2008-02-14
Last updated
2014-02-28

Locations

20 sites across 5 countries: United States, Belgium, Brazil, Germany, Israel

Source: ClinicalTrials.gov record NCT00615940. Inclusion in this directory is not an endorsement.