Clinical trial · Interventional
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane
NCT00568022CI-TRIAL-00021279completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ixabepilone + Capecitabine
- interventionNames
- Drug: Ixabepilone
- Drug: Capecitabine
Primary outcomes (2)
- measure
- Participants Experiencing Dose Limiting Toxicity (DLT)
- timeFrame
- From initiation of drug through last day of Cycle 2 (Day 42)
- description
- DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.
- measure
- Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
- timeFrame
- At the end of Cycle 2 (Day 42)
- description
- The MTD was defined as the highest dose evaluated for which less than 1/3 of the participants experienced DLT during the first two treatment cycles. If toxicities (e.g. hand-foot syndrome, existing peripheral neuropathy, etc.) occurred or became more severe in later cycles, the recommended Phase II dose was to be determined after due consideration of their severity.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.