Phase 1
Completed N=9
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00568022 ↗Enrolled (actual)
9
Serious AEs
22.2%
Results posted
Aug 2011
Primary outcomePrimary: Participants Experiencing Dose Limiting Toxicity (DLT) — 0; 0; 0 Participants
Summary
The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Experiencing Dose Limiting Toxicity (DLT) |
0; 0; 0 | — |
| PRIMARY Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) |
3; 3 | — |
| SECONDARY Adverse Events (AEs) and Serious Adverse Events (SAEs) |
3; 3; 3; 3; 3; 3 | — |
| SECONDARY Participant Tumor Response at Study Endpoint |
0; 0; 1; 1; 1; 2 | — |
| SECONDARY Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval |
164.01; 219.44; 192.13 | — |
| SECONDARY Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval |
1260.71; 1676.46; 1417.78 | — |
| SECONDARY Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval |
41.77; 44.17; 54.27 | — |
| SECONDARY Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval |
1910.13; 1498.46; 2055.55 | — |
| SECONDARY Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval |
41.52; 37.21; 42.79 | — |
Eligibility Criteria
Inclusion Criteria
- Women ≥ 20 years
- Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast
Exclusion Criteria
- Number of prior chemotherapy lines of treatment in the metastatic setting ≥3
Data sourced from ClinicalTrials.gov (NCT00568022). 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.