Evaluate Safety, Efficacy and Pharmacokinetics
Phase 1/2
Completed
NCT01084863
| Condition | Metastatic Breast Cancer |
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| Phase | Phase 1/2 |
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| Sponsor | Celltrion |
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| Status | Completed |
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| Enrollment | 143 participants |
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| Interventions | CT-P6, Herceptin, Paclitaxel |
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| Start date | Feb, 2010 |
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| Completion date | Dec, 2011 |
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| Results posted | Jan 24, 2025 |
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Summary
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
Area Under the Concentration Time Curve at Steady State (AUCss)
3, 6, 12, 24, 72, 168, 336, 504 hours predose · ug*h/mL
| CT-P6 & Paclitaxel | 34400 ± 15000 ug*h/mL |
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| Herceptin & Paclitaxel | 31800 ± 9820 ug*h/mL |
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| Geometric Mean Ratio | 104.57 (95% CI 93.64–116.78) |
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Open in BENITIONS
View on ClinicalTrials.gov
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