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

NCT00615940 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2014-02-28

No results posted yet for this study

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

DRUG

WX-671

capsules taken per os once daily until progression or toxicity

DRUG

placebo

capsule taken per os once daily until progression or toxicity

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Heidelberg Pharma AG

    lead INDUSTRY

Principal Investigators

  • Lori Goldstein, MD · Dept. of Medical Oncology, Division of Medical Science, Fox Chase Cancer Center, 7701 Burholme Avenue, Philadelphia, Pennsylvania 19111, USA

  • Nadia Harbeck, MD · Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Uniklinik Köln

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-12-31
Completion
2012-04-30

Countries

  • United States
  • Belgium
  • Brazil
  • Germany
  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00615940 on ClinicalTrials.gov