Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Capecitabine

Taxane

Antimetabolites

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

Ixabepilone

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

Bristol-Myers Squibb

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.

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

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

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.

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

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.

Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples 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.

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

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

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

R-Pharm

Ixabepilone 32 mg/m\^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m\^2/day was administered on Days 1 to 14 of each treatment cycle.

Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day

Ixabepilone 40 mg/m\^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m\^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.

Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day

Ixabepilone 40 mg/m\^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m\^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.

Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day

Ixabepilone 32 mg/m\^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m\^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Japan

Region of Enrollment

BMS Study Director

All participants who received at least 1 dose of either ixabepilone or capecitabine.

Participants Experiencing Dose Limiting Toxicity (DLT)

Related AEs

Discontinued Due to AEs

SAEs

Related SAEs

Discontinued Due to SAEs

Deaths

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

All treated participants with measurable disease and tumor response.

Participant Tumor Response at Study Endpoint

All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.

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

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

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

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

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

Ixa 40 mg/m^2 + Cap 2000 mg/m^2 MTD

Ixa 40 mg/m^2 + Cap 2000 ng/m^2 RP2D

The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥ 1 dose of ixabepilone and/or capecitabine in Cycle 1, completed adequate safety evaluations, and was observed for ≥ 21 days following the first dose or the participant experienced DLT.

All Participants With Measurable Disease and Tumor Response

All participants treated at the highest dose level.

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

After receiving Ixabepilone 32 mg/m\^2 + Capecitabine 1650 mg/m\^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m\^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m\^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.

After receiving Ixabepilone 40 mg/m\^2 + Capecitabine 1650 mg/m\^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m\^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m\^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.

Spots Global Cancer Trial Database for A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

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Study Description

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