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

• Sponsor: R-Pharm (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00568022
• Collaborator: (none)
• Enrollment: 9
• Locations: 4
• Arm: 1
• Duration (Months): 23
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Ixabepilone; Drug: Capecitabine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ixabepilone + Capecitabine	Drug: Ixabepilone; Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles; Other Names: IXEMPRA BMS-247550 ; Drug: Capecitabine; Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles

Outcome Measures

Primary Outcome Measures

1. Participants Experiencing Dose Limiting Toxicity (DLT) [From initiation of drug through last day of Cycle 2 (Day 42)]

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

2. Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) [At the end of Cycle 2 (Day 42)]

   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.

Secondary Outcome Measures

1. Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline to Day 42, continuously]

   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

2. Participant Tumor Response at Study Endpoint [At baseline and after every 42 days (every 2 21-day cycles) after baseline]

   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.

3. Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval [During Cycle 1 at specified timepoints (Day 1 to Day 8).]

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

4. Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval [During Cycle 1 at specified timepoints (Day 1 to Day 8).]

   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.

5. Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval [During Cycle 1 at specified timepoints (Day 1 to Day 8).]

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

6. Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval [During Cycle 1 at specified timepoints (Day 1 to Day 8).]

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

7. Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval [During Cycle 1 at specified timepoints (Day 1 to Day 8).]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Matsuyama-Shi	Ehime	Japan	7910280
2	Local Institution	Maebashi-Shi	Gunma	Japan	371-8511
3	Local Institution	Sunto-Gun	Shizuoka	Japan	411-8777
4	Local Institution	Osaka		Japan	540-0006

Sponsors and Collaborators

• R-Pharm

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: R-Pharm
• ClinicalTrials.gov Identifier: NCT00568022
• Other Study ID Numbers: CA163-117
• First Posted: Dec 5, 2007
• Last Update Posted: Mar 10, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Breast Neoplasms; Capecitabine

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 4 sites in Japan.

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	3	3	3
COMPLETED	3	3	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day	Total
Arm/Group Description	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.	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 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.	Total of all reporting groups
Overall Participants	3	3	3	9
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	3 100%	2 66.7%	8 88.9%
>=65 years	0 0%	0 0%	1 33.3%	1 11.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.0 (13.00)	52.7 (4.73)	52.7 (20.26)	53.1 (12.28)
Sex: Female, Male (Count of Participants)
Female	3 100%	3 100%	3 100%	9 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Japan	3 100%	3 100%	3 100%	9 100%

Outcome Measures

1. Primary Outcome

Title	Participants Experiencing Dose Limiting Toxicity (DLT)
Description	DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.
Time Frame	From initiation of drug through last day of Cycle 2 (Day 42)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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 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.
Measure Participants	3	3	3
Number [Participants]	0 0%	0 0%	0 0%

2. Secondary Outcome

Title	Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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
Time Frame	Baseline to Day 42, continuously

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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 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.
Measure Participants	3	3	3
AEs	3 100%	3 100%	3 100%
Related AEs	3 100%	3 100%	3 100%
Discontinued Due to AEs	0 0%	0 0%	0 0%
SAEs	0 0%	1 33.3%	1 33.3%
Related SAEs	0 0%	1 33.3%	1 33.3%
Discontinued Due to SAEs	0 0%	0 0%	0 0%
Deaths	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Participant Tumor Response at Study Endpoint
Description	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.
Time Frame	At baseline and after every 42 days (every 2 21-day cycles) after baseline

Outcome Measure Data

Analysis Population Description

All treated participants with measurable disease and tumor response.

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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 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.
Measure Participants	3	3	3
CR	0 0%	0 0%	1 33.3%
PR	1 33.3%	1 33.3%	2 66.7%
PD	1 33.3%	1 33.3%	0 0%
SD	1 33.3%	1 33.3%	0 0%

4. Secondary Outcome

Title	Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval
Description	Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.
Time Frame	During Cycle 1 at specified timepoints (Day 1 to Day 8).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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 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.
Measure Participants	3	3	3
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]	164.01 (30)	219.44 (13)	192.13 (6)

5. Secondary Outcome

Title	Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval
Description	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.
Time Frame	During Cycle 1 at specified timepoints (Day 1 to Day 8).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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 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.
Measure Participants	3	3	3
Geometric Mean (Geometric Coefficient of Variation) [ng·h/mL]	1260.71 (1)	1676.46 (24)	1417.78 (10)

6. Secondary Outcome

Title	Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval
Description	T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.
Time Frame	During Cycle 1 at specified timepoints (Day 1 to Day 8).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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 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.
Measure Participants	3	3	3
Mean (Standard Deviation) [Hours]	41.77 (9)	44.17 (8)	54.27 (16)

7. Secondary Outcome

Title	Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval
Description	Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.
Time Frame	During Cycle 1 at specified timepoints (Day 1 to Day 8).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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 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.
Measure Participants	3	3	3
Mean (Standard Deviation) [Liters]	1910.13 (423)	1498.46 (140)	2055.55 (795)

8. Secondary Outcome

Title	Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval
Description	CLT = total body clearance as determined from participant serum samples in one dosing interval.
Time Frame	During Cycle 1 at specified timepoints (Day 1 to Day 8).

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day	Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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.	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 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.
Measure Participants	3	3	3
Mean (Standard Deviation) [L/h]	41.52 (2)	37.21 (7)	42.79 (7)

9. Primary Outcome

Title	Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
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.
Time Frame	At the end of Cycle 2 (Day 42)

Outcome Measure Data

Analysis Population Description

All participants treated at the highest dose level.

Arm/Group Title	All Participants With Measurable Disease and Tumor Response
Arm/Group Description	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.
Measure Participants	3
Ixa 40 mg/m^2 + Cap 2000 mg/m^2 MTD	3 100%
Ixa 40 mg/m^2 + Cap 2000 ng/m^2 RP2D	3 100%

Adverse Events

Arm/Group Title	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day		Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day		Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Arm/Group Description	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 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 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.
All Cause Mortality
	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day		Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day		Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day		Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day		Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)
Blood and lymphatic system disorders
NEUTROPENIA	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Infections and infestations
SKIN INFECTION	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day		Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day		Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		3/3 (100%)
Blood and lymphatic system disorders
LEUKOPENIA	3/3 (100%)		3/3 (100%)		3/3 (100%)
LYMPHOPENIA	0/3 (0%)		0/3 (0%)		2/3 (66.7%)
NEUTROPENIA	3/3 (100%)		3/3 (100%)		3/3 (100%)
THROMBOCYTOPENIA	0/3 (0%)		3/3 (100%)		3/3 (100%)
Gastrointestinal disorders
NAUSEA	1/3 (33.3%)		3/3 (100%)		2/3 (66.7%)
VOMITING	1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)
CHEILITIS	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)
DIARRHOEA	2/3 (66.7%)		2/3 (66.7%)		1/3 (33.3%)
GASTRITIS	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
TOOTHACHE	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
STOMATITIS	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
CONSTIPATION	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)
TONGUE PIGMENTATION	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
ABDOMINAL DISCOMFORT	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
ABDOMINAL PAIN UPPER	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)
General disorders
OEDEMA	1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)
FATIGUE	3/3 (100%)		3/3 (100%)		3/3 (100%)
PYREXIA	0/3 (0%)		2/3 (66.7%)		1/3 (33.3%)
EXTRAVASATION	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
OEDEMA PERIPHERAL	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
INJECTION SITE OEDEMA	0/3 (0%)		2/3 (66.7%)		1/3 (33.3%)
INFLUENZA LIKE ILLNESS	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)
INJECTION SITE REACTION	1/3 (33.3%)		0/3 (0%)		2/3 (66.7%)
Hepatobiliary disorders
HYPERBILIRUBINAEMIA	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Immune system disorders
SEASONAL ALLERGY	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Infections and infestations
PARONYCHIA	1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)
LYMPHANGITIS	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
SKIN INFECTION	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
NASOPHARYNGITIS	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
Injury, poisoning and procedural complications
CONTUSION	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
LIMB INJURY	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
RADIATION SKIN INJURY	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Investigations
WEIGHT DECREASED	2/3 (66.7%)		1/3 (33.3%)		1/3 (33.3%)
HAEMOGLOBIN DECREASED	1/3 (33.3%)		2/3 (66.7%)		3/3 (100%)
MONOCYTE COUNT DECREASED	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
ALANINE AMINOTRANSFERASE INCREASED	0/3 (0%)		2/3 (66.7%)		1/3 (33.3%)
ASPARTATE AMINOTRANSFERASE INCREASED	0/3 (0%)		2/3 (66.7%)		2/3 (66.7%)
Metabolism and nutrition disorders
DECREASED APPETITE	2/3 (66.7%)		3/3 (100%)		3/3 (100%)
Musculoskeletal and connective tissue disorders
MYALGIA	3/3 (100%)		3/3 (100%)		2/3 (66.7%)
ARTHRALGIA	2/3 (66.7%)		3/3 (100%)		3/3 (100%)
MUSCLE SPASMS	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
SPINAL OSTEOARTHRITIS	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
Nervous system disorders
HEADACHE	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
DIZZINESS	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
DYSGEUSIA	0/3 (0%)		1/3 (33.3%)		2/3 (66.7%)
NEURALGIA	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
PERIPHERAL SENSORY NEUROPATHY	3/3 (100%)		3/3 (100%)		3/3 (100%)
Psychiatric disorders
SLEEP DISORDER	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
DYSPHONIA	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
OROPHARYNGEAL PAIN	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
OROPHARYNGEAL DISCOMFORT	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
Skin and subcutaneous tissue disorders
RASH	2/3 (66.7%)		2/3 (66.7%)		0/3 (0%)
PRURIGO	1/3 (33.3%)		0/3 (0%)		0/3 (0%)
ALOPECIA	0/3 (0%)		1/3 (33.3%)		2/3 (66.7%)
DRY SKIN	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
ERYTHEMA	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
NAIL DISORDER	2/3 (66.7%)		2/3 (66.7%)		1/3 (33.3%)
SKIN DISORDER	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
NAIL DISCOLOURATION	0/3 (0%)		0/3 (0%)		1/3 (33.3%)
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	2/3 (66.7%)		0/3 (0%)		3/3 (100%)
Vascular disorders
FLUSHING	0/3 (0%)		1/3 (33.3%)		0/3 (0%)
PHLEBITIS	0/3 (0%)		0/3 (0%)		1/3 (33.3%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.