Phase 1
N=42
Phase I Combination w/ Epirubicin
Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00322374 ↗Enrolled (actual)
42
Serious AEs
26.2%
Results posted
Aug 2010
Primary outcome: Primary: Number of Participants With a Dose Limiting Toxicity (DLT) — 1; 1; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ixabepilone (Drug); Epirubicin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- R-Pharm
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Dose Limiting Toxicity (DLT) |
1; 1; 2; 1; 1; 2 | — |
| PRIMARY Ixabepilone Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (R2PD) |
30; 30 | — |
| SECONDARY Number of Participants With Death, Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3/4 AEs, or AEs Leading to Discontinuation |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Single-dose Ixabepilone |
169.00; 217.86; 251.83 | — |
| SECONDARY Area Under the Curve, Extrapolated to Infinity (AUC[INF]) of Single-dose Ixabepilone |
1760.42; 2072.43; 2100.56 | — |
| SECONDARY Terminal Half-life (T-Half) of Single-dose Ixabepilone |
51.82; 34.07; 44.15 | — |
| SECONDARY Clearance (CLT) of Single-dose Ixabepilone |
26.03; 24.62; 26.68 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Single-dose Ixabepilone |
1331.65; 803.21; 1001.70 | — |
| SECONDARY Epirubicin Cmax |
3306.53; 4139.00; 4533.08 | — |
| SECONDARY Epirubicin AUC(INF) |
2489.37; 3132.67; 2595.44 | — |
| SECONDARY Epirubicin T-Half |
13.61; 19.41; 15.55 | — |
| SECONDARY Epirubicin CLT |
81.33; 53.85; 58.00 | — |
| SECONDARY Epirubicin Vss |
912.83; 750.24; 522.45 | — |
| SECONDARY Number Of Participants With A Best Overall Tumor Response of Complete Response, Partial Response, Stable Disease, And Progressive Disease |
0; 0; 18; 9; 11; 10 | — |
| SECONDARY Duration of Tumor Response |
6.45; 6.4 | — |
| SECONDARY Number Of Participants With Tumor Response by Duration of Response Category |
5; 1; 13; 8; 11; 6 | — |
Summary
Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Eligibility Criteria
Inclusion Criteria
- Women ≥18 years
- Histologically or cytologically confirmed diagnosis of metastatic breast cancer
- Measurable or nonmeasurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST)
Exclusion Criteria
- Number of prior chemotherapy lines of treatment in the metastatic setting ≥2
Data sourced from ClinicalTrials.gov (NCT00322374). 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.