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Combination Study of a New Taxane and Capecitabine in Patients With Metastatic Breast Cancer

NCT00327743 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-05-18

No results posted yet for this study

Summary

The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.

Conditions

Interventions

DRUG

larotaxel

IV infusion on Day 1 of a 21-day cycle

DRUG

capecitabine

oral, twice daily, Day 1-Day 14 of a 21-day cycle

Sponsors & Collaborators

Principal Investigators

  • ICD · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States
  • France

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 NCT00327743 on ClinicalTrials.gov