Phase 2
Completed N=143
Evaluate Safety, Efficacy and Pharmacokinetics
Source: ClinicalTrials.gov NCT01084863 ↗Enrolled (actual)
143
Serious AEs
21.7%
Results posted
Jan 2025
Primary outcomePrimary: Area Under the Concentration Time Curve at Steady State (AUCss) — 34400; 31800 ug*h/mL
Summary
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration Time Curve at Steady State (AUCss) |
34400; 31800 | — |
| SECONDARY Trough Concentration at Steady State (CtroughSS) |
21.1; 20.8 | — |
| SECONDARY Cardiotoxicity |
-5.49; -6.43 | — |
| SECONDARY Immunogenicity |
2; 0 | — |
| SECONDARY Overall Response Rate (ORR; Complete Response [CR] Plus Partial Response [PR]) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
61.8; 76.1; 68.4; 80.6; 65.8; 77.6 | — |
| SECONDARY Serum Human Epidermal Growth Factor Receptor-2 (HER-2) Shed Antigen Value |
85.20; 77.87; 49.68; 8.82 | — |
Eligibility Criteria
Inclusion Criteria
- Are females
- Have a Her 2 over-expression
- Have Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
- Current clinical or radiographic evidence central nervous system (CNS) metastases
- Current Known infection
- Pregnant or nursing mother
Data sourced from ClinicalTrials.gov (NCT01084863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.