A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

Sperimentale: Ixabepilone + Capecitabine

Droga: Ixabepilone

Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles

Altri nomi:

• BMS-247550
• IXEMPRA

Droga: Capecitabine

Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles

Participants Experiencing Dose Limiting Toxicity (DLT)

DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.

Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

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.

Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug

Participant Tumor Response at Study Endpoint

Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) in which complete response (CR) = disappearance of all target lesions; partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions; and stable disease (SD) = small changes that do not meet above criteria.

Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval

Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.

Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval

AUC = the average area under the concentration curve (AUC [INF]) of ixabepilone as determined from participant serum samples in one dosing interval over 24 hours.

Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval

T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.

Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval

Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.

Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval

CLT = total body clearance as determined from participant serum samples in one dosing interval.