Trial Outcomes & Findings for A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer (NCT NCT00568022)
NCT ID: NCT00568022
Last Updated: 2016-03-10
Results Overview
DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
From initiation of drug through last day of Cycle 2 (Day 42)
Results posted on
2016-03-10
Participant Flow
Participants were recruited from 4 sites in Japan.
Participant milestones
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 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.
|
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day
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.
|
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 13.00 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 4.73 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 20.26 • n=5 Participants
|
53.1 years
STANDARD_DEVIATION 12.28 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From initiation of drug through last day of Cycle 2 (Day 42)Population: All participants who received at least 1 dose of either ixabepilone or capecitabine.
DLT was defined as any ixabepilone and/or capecitabine related events requiring study discontinuation during the first two treatment cycles.
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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.
|
|---|---|---|---|
|
Participants Experiencing Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At the end of Cycle 2 (Day 42)Population: All participants treated at the highest dose level.
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.
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + 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 2000 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.
|
|---|---|---|---|
|
Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Ixa 40 mg/m^2 + Cap 2000 mg/m^2 MTD
|
3 Participants
|
—
|
—
|
|
Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
Ixa 40 mg/m^2 + Cap 2000 ng/m^2 RP2D
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 42, continuouslyPopulation: All participants who received at least 1 dose of either ixabepilone or capecitabine.
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
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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.
|
|---|---|---|---|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Related AEs
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Discontinued Due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Discontinued Due to SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and after every 42 days (every 2 21-day cycles) after baselinePopulation: All treated participants with measurable disease and tumor response.
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.
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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.
|
|---|---|---|---|
|
Participant Tumor Response at Study Endpoint
SD
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Participant Tumor Response at Study Endpoint
CR
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participant Tumor Response at Study Endpoint
PR
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Participant Tumor Response at Study Endpoint
PD
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).Population: All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.
Cmax = maximum observed plasma concentration of ixabepilone as determined from participant serum samples in one dosing interval.
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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.
|
|---|---|---|---|
|
Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval
|
164.01 ng/mL
Geometric Coefficient of Variation 30
|
219.44 ng/mL
Geometric Coefficient of Variation 13
|
192.13 ng/mL
Geometric Coefficient of Variation 6
|
SECONDARY outcome
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).Population: All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.
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.
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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.
|
|---|---|---|---|
|
Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval
|
1260.71 ng·h/mL
Geometric Coefficient of Variation 1
|
1676.46 ng·h/mL
Geometric Coefficient of Variation 24
|
1417.78 ng·h/mL
Geometric Coefficient of Variation 10
|
SECONDARY outcome
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).Population: All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.
T 1/2 = terminal elimination half life as determined from participant serum samples in one dosing interval.
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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.
|
|---|---|---|---|
|
Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval
|
41.77 Hours
Standard Deviation 9
|
44.17 Hours
Standard Deviation 8
|
54.27 Hours
Standard Deviation 16
|
SECONDARY outcome
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).Population: All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.
Vss = volume of distribution at steady state determined from participant serum samples from one dosing interval.
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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.
|
|---|---|---|---|
|
Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval
|
1910.13 Liters
Standard Deviation 423
|
1498.46 Liters
Standard Deviation 140
|
2055.55 Liters
Standard Deviation 795
|
SECONDARY outcome
Timeframe: During Cycle 1 at specified timepoints (Day 1 to Day 8).Population: All participants who received ixabepilone and capecitabine and who had adequate PK concentration profiles.
CLT = total body clearance as determined from participant serum samples in one dosing interval.
Outcome measures
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 + Capecitabine 1650 mg/m^2/Day
n=3 Participants
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 2000 mg/m^2/Day
n=3 Participants
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.
|
|---|---|---|---|
|
Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval
|
41.52 L/h
Standard Deviation 2
|
37.21 L/h
Standard Deviation 7
|
42.79 L/h
Standard Deviation 7
|
Adverse Events
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 participants at risk
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 + Capecitabine 1650 mg/m^2/Day
n=3 participants at risk
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 2000 mg/m^2/Day
n=3 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
Other adverse events
| Measure |
Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day
n=3 participants at risk
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 + Capecitabine 1650 mg/m^2/Day
n=3 participants at risk
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 2000 mg/m^2/Day
n=3 participants at risk
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.
|
|---|---|---|---|
|
Investigations
WEIGHT DECREASED
|
66.7%
2/3
|
33.3%
1/3
|
33.3%
1/3
|
|
Investigations
HAEMOGLOBIN DECREASED
|
33.3%
1/3
|
66.7%
2/3
|
100.0%
3/3
|
|
Investigations
MONOCYTE COUNT DECREASED
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/3
|
66.7%
2/3
|
66.7%
2/3
|
|
Vascular disorders
FLUSHING
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/3
|
33.3%
1/3
|
66.7%
2/3
|
|
Nervous system disorders
NEURALGIA
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
3/3
|
|
Gastrointestinal disorders
NAUSEA
|
33.3%
1/3
|
100.0%
3/3
|
66.7%
2/3
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
1/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
|
Gastrointestinal disorders
DIARRHOEA
|
66.7%
2/3
|
66.7%
2/3
|
33.3%
1/3
|
|
Gastrointestinal disorders
GASTRITIS
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
|
Gastrointestinal disorders
TONGUE PIGMENTATION
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
|
Infections and infestations
PARONYCHIA
|
33.3%
1/3
|
33.3%
1/3
|
33.3%
1/3
|
|
Infections and infestations
LYMPHANGITIS
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
66.7%
2/3
|
100.0%
3/3
|
100.0%
3/3
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
3/3
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/3
|
0.00%
0/3
|
66.7%
2/3
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
3/3
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/3
|
100.0%
3/3
|
100.0%
3/3
|
|
Skin and subcutaneous tissue disorders
RASH
|
66.7%
2/3
|
66.7%
2/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
PRURIGO
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/3
|
33.3%
1/3
|
66.7%
2/3
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
66.7%
2/3
|
66.7%
2/3
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLOURATION
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
66.7%
2/3
|
0.00%
0/3
|
100.0%
3/3
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
RADIATION SKIN INJURY
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
100.0%
3/3
|
100.0%
3/3
|
66.7%
2/3
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
66.7%
2/3
|
100.0%
3/3
|
100.0%
3/3
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
33.3%
1/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL DISCOMFORT
|
0.00%
0/3
|
33.3%
1/3
|
0.00%
0/3
|
|
General disorders
OEDEMA
|
33.3%
1/3
|
0.00%
0/3
|
33.3%
1/3
|
|
General disorders
FATIGUE
|
100.0%
3/3
|
100.0%
3/3
|
100.0%
3/3
|
|
General disorders
PYREXIA
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
|
General disorders
EXTRAVASATION
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3
|
|
General disorders
INJECTION SITE OEDEMA
|
0.00%
0/3
|
66.7%
2/3
|
33.3%
1/3
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/3
|
33.3%
1/3
|
33.3%
1/3
|
|
General disorders
INJECTION SITE REACTION
|
33.3%
1/3
|
0.00%
0/3
|
66.7%
2/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER