Eisai Clinical Trials
Study Overview
E7389
eribulin mesilate
NCT02225470
Sep 2013 - Jun 2018
Breast Cancer
1. Progression-Free Survival (PFS) of Eribulin Arm by tumor assessment : Time to disease progression [ Time Frame: Baseline until date of recorded disease progression or death, or up to 2 years ]
2. Progression-Free Survival (PFS) of Vinorelbine Arm by tumor assessment: Time to disease progression [ Time Frame: Baseline until date of recorded disease progression or death, or up to 2 years ]
3. Maximum observed plasma concentration (Cmax) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
4. Time at which the highest drug concentration occurs (tmax) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
5. Area under the plasma concentration-time curve (AUC) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
6. Terminal phase rate constant (lambda Z) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
7. Terminal elimination phase half-life (t1/2) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
8. Distribution volume at steady-state (Vss) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
9. Total clearance (CL) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
2. Progression-Free Survival (PFS) of Vinorelbine Arm by tumor assessment: Time to disease progression [ Time Frame: Baseline until date of recorded disease progression or death, or up to 2 years ]
3. Maximum observed plasma concentration (Cmax) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
4. Time at which the highest drug concentration occurs (tmax) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
5. Area under the plasma concentration-time curve (AUC) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
6. Terminal phase rate constant (lambda Z) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
7. Terminal elimination phase half-life (t1/2) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
8. Distribution volume at steady-state (Vss) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
9. Total clearance (CL) of Eribulin Arm in a minimum of 15 subjects [ Time Frame: Day 1 and Day 8 ]
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Females 18 Years to 70 Years (Adult, Older Adult)
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Completed -
Phase 3
ChinaData Sharing
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CSDR Availability Clinical Trial Data Redacted documents may be available upon request for this study.
Document type Availability Protocol SAP Sample CRF Full CSR