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Capecitabine and Exisulind in Metastatic Breast Cancer
NCT00037609Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2001
- Primary completion
- Feb 2003
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- exisulind
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of exisulind in breast cancer, sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Objective Response Rate at 6 weeks. Started Jan 2001; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Capecitabine + Exisulind
Capecitabine 1000 mg/m^2 taken by mouth twice daily. Exisulind 125 mg taken by mouth twice daily.
03
Who it enrols
Patients with metastatic breast cancer who have received both anthracycline and taxane chemotherapy, with adequate organ function and Zubrod PS < 2.
04
Endpoints
Primary
Objective Response Rate
Secondary
Pharmacokinetics
Toxicity
Duration of Response
Time to Progression
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