Trial Outcomes & Findings for Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer (NCT NCT00546364)
NCT ID: NCT00546364
Last Updated: 2016-03-10
Results Overview
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Baseline to 6 weeks (end of Cycle 2)
Results posted on
2016-03-10
Participant Flow
Of 62 participants enrolled, 62 were randomized and received treatment. Investigators had to terminate the study because an adequate number of participants could not be enrolled.
Participant milestones
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
20
|
|
Overall Study
Never Treated
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
17
|
18
|
17
|
Reasons for withdrawal
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Overall Study
Disease progression
|
5
|
11
|
8
|
|
Overall Study
Completed and off treatment
|
1
|
0
|
2
|
|
Overall Study
Administrative reason by sponsor
|
1
|
0
|
0
|
|
Overall Study
Poor compliance/noncompliance
|
0
|
0
|
1
|
|
Overall Study
No longer meets study criteria
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
3
|
|
Overall Study
Prior taxotere
|
1
|
0
|
0
|
|
Overall Study
Mixed response
|
1
|
0
|
0
|
|
Overall Study
Palliative treatment
|
1
|
0
|
1
|
|
Overall Study
Target lesions resected
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Sponsor decision
|
0
|
0
|
1
|
Baseline Characteristics
Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=22 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
n=93 Participants
|
59 years
n=4 Participants
|
55.5 years
n=27 Participants
|
57.5 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (end of Cycle 2)Population: All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Outcome measures
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=22 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Partial response (PR)
|
6 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Complete response (CR)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Stable disease (SD)
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive disease (PD)
|
4 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Discontinued before first tumor assessment
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
No tumor assessment due to other reasons
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Unable to determine
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeks (end of Cycle 2)Population: All participants with measurable disease who have a correct cancer diagnosis and have received any treatment.
The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.
Outcome measures
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=22 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Percentage of Participants With Best Response to Treatment of Complete or Partial
|
35 Percentage of patients
|
41 Percentage of patients
|
30 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to 6 weeks (end of Cycle 2)Population: All TN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).
Outcome measures
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=8 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=9 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=8 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial
|
38 Percentage of TN Participants
|
22 Percentage of TN Participants
|
13 Percentage of TN Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 weeks (end of Cycle 2)Population: All NTN participants who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.
Outcome measures
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=12 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=13 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=12 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort
|
33 Percentage of NTN Participants
|
54 Percentage of NTN Participants
|
42 Percentage of NTN Participants
|
SECONDARY outcome
Timeframe: Baseline to end of Cycle 1 (21 days), continuouslyPopulation: All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.
Outcome measures
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=22 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related AEDs (Grade 3)
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Deaths
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
AEs
|
20 Participants
|
22 Participants
|
20 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related AEs
|
20 Participants
|
22 Participants
|
19 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related AEs (Grade 3)
|
8 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related AEs (Grade 4)
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
SAEs
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related SAEs
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related SAEs (Grade 3)
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related SAEs (Grade 4)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
AEDs
|
4 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related AEDs
|
2 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related AEDs (Grade 4)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related peripheral neuropathy
|
10 Participants
|
15 Participants
|
5 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related peripheral neuropathy (Grade 3)
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy
Drug-related peripheral neuropathy (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cyclePopulation: All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.
Outcome measures
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=22 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Neutropenia (Grades 1-4)
|
18 Participants
|
15 Participants
|
17 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Neutropenia (Grade 3 or 4)
|
12 Participants
|
10 Participants
|
15 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Leukopenia (Grades 1-4)
|
20 Participants
|
19 Participants
|
17 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Leukopenia (Grade 3 or 4)
|
9 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Thrombocytopenia (Grades 1-4)
|
9 Participants
|
11 Participants
|
7 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Thrombocytopenia (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Anemia (Grades 1-4)
|
18 Participants
|
21 Participants
|
17 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade
Anemia (Grade 3 or 4)
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cyclePopulation: All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:\>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. Aspartate aminotransferase (AST) Grade 1: \>ULN to 2.5\*ULN; Grade 2: \>2.5 to 5.0\*ULN; Grade 3: \>5.0 to 20.0\*ULN; Grade 4: \>20.0\*ULN. Total bilirubin Grade 1: \>ULN to 1.5\*ULN; Grade 2: \>1.5 to 3.0\*ULN; Grade 3: \>3.0 to 10.0\*ULN; Grade 4: \>10.0\*ULN. Creatine Grade 1: \>ULN to 1.5\*ULN; Grade 2: 1.5 to 3.0\*ULN; Grade 3: \>3.0 to 6.0\*ULN; Grade 4: \>6.0\*ULN.
Outcome measures
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=22 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
ALT, high (Grades 1-4)
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
ALT, high (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
AST, high (Grades 1-4)
|
7 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
AST, high (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
Total bilirubin, high (Grades 1-4)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
Total bilirubin, high (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
Creatinine, high (Grades 1-4)
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Results
Creatinine, high (Grade 3 or 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to date progressive disease reportedPopulation: This study was terminated due to inadequate enrollment. Consequently, time to progression was not analyzed.
Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (date of randomization) to date CR or PR criteria first metPopulation: This study was terminated due to inadequate enrollment. Consequently, duration of response was not analyzed.
Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to end of Cycle 18, maximum (54 weeks)Population: All participants who received at least 1 dose of ixabepilone plus capecitabine or of docetaxel plus capecitabine.
The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.
Outcome measures
| Measure |
Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Ixabepilone, 40 mg/m\^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
n=22 Participants
Ixabepilone, 32 mg/m\^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
n=20 Participants
Docetaxel, 75 mg/m\^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m\^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
|
|---|---|---|---|
|
Median Number of Treatment Cycles
|
3.0 Treatment cycles
Interval 1.0 to 16.0
|
4.5 Treatment cycles
Interval 1.0 to 18.0
|
6.0 Treatment cycles
Interval 1.0 to 17.0
|
Adverse Events
Docetaxel
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Ixabepilone 32
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Ixabepilone 40
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel
n=20 participants at risk
|
Ixabepilone 32
n=22 participants at risk
|
Ixabepilone 40
n=20 participants at risk
|
|---|---|---|---|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Vascular disorders
HYPOTENSION
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/20
|
9.1%
2/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
COLONIC OBSTRUCTION
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.0%
1/20
|
4.5%
1/22
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.0%
1/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
10.0%
2/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
INCISION SITE PAIN
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
General disorders
ASTHENIA
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/20
|
4.5%
1/22
|
0.00%
0/20
|
|
General disorders
CATHETER THROMBOSIS
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
Other adverse events
| Measure |
Docetaxel
n=20 participants at risk
|
Ixabepilone 32
n=22 participants at risk
|
Ixabepilone 40
n=20 participants at risk
|
|---|---|---|---|
|
Eye disorders
DRY EYE
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Eye disorders
PHOTOPHOBIA
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/20
|
9.1%
2/22
|
0.00%
0/20
|
|
Eye disorders
VISUAL IMPAIRMENT
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Eye disorders
LACRIMATION INCREASED
|
15.0%
3/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Eye disorders
OCULAR SURFACE DISEASE
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Investigations
WEIGHT DECREASED
|
15.0%
3/20
|
9.1%
2/22
|
25.0%
5/20
|
|
Investigations
HAEMOGLOBIN DECREASED
|
10.0%
2/20
|
45.5%
10/22
|
25.0%
5/20
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.00%
0/20
|
9.1%
2/22
|
0.00%
0/20
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/20
|
13.6%
3/22
|
5.0%
1/20
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Investigations
EOSINOPHIL COUNT DECREASED
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
15.0%
3/20
|
9.1%
2/22
|
25.0%
5/20
|
|
Investigations
EJECTION FRACTION DECREASED
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Investigations
GRANULOCYTE COUNT DECREASED
|
5.0%
1/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
15.0%
3/20
|
22.7%
5/22
|
20.0%
4/20
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/20
|
4.5%
1/22
|
10.0%
2/20
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.0%
1/20
|
9.1%
2/22
|
15.0%
3/20
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/20
|
13.6%
3/22
|
0.00%
0/20
|
|
Cardiac disorders
TACHYCARDIA
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Cardiac disorders
PALPITATIONS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/20
|
0.00%
0/22
|
10.0%
2/20
|
|
Vascular disorders
FLUSHING
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/20
|
13.6%
3/22
|
0.00%
0/20
|
|
Vascular disorders
HYPOTENSION
|
5.0%
1/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Vascular disorders
LYMPHOEDEMA
|
5.0%
1/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Vascular disorders
HYPERTENSION
|
5.0%
1/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Vascular disorders
VENOUS THROMBOSIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Psychiatric disorders
ANXIETY
|
15.0%
3/20
|
13.6%
3/22
|
5.0%
1/20
|
|
Psychiatric disorders
INSOMNIA
|
5.0%
1/20
|
18.2%
4/22
|
0.00%
0/20
|
|
Psychiatric disorders
DEPRESSION
|
5.0%
1/20
|
13.6%
3/22
|
10.0%
2/20
|
|
Immune system disorders
HYPERSENSITIVITY
|
10.0%
2/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Nervous system disorders
HEADACHE
|
20.0%
4/20
|
13.6%
3/22
|
15.0%
3/20
|
|
Nervous system disorders
MIGRAINE
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Nervous system disorders
DIZZINESS
|
5.0%
1/20
|
4.5%
1/22
|
15.0%
3/20
|
|
Nervous system disorders
DYSGEUSIA
|
10.0%
2/20
|
13.6%
3/22
|
15.0%
3/20
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/20
|
9.1%
2/22
|
5.0%
1/20
|
|
Nervous system disorders
HYPOAESTHESIA
|
5.0%
1/20
|
9.1%
2/22
|
0.00%
0/20
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
15.0%
3/20
|
31.8%
7/22
|
10.0%
2/20
|
|
Nervous system disorders
EXTRAPYRAMIDAL DISORDER
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
15.0%
3/20
|
36.4%
8/22
|
35.0%
7/20
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
10/20
|
77.3%
17/22
|
40.0%
8/20
|
|
Gastrointestinal disorders
VOMITING
|
20.0%
4/20
|
36.4%
8/22
|
30.0%
6/20
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.0%
8/20
|
54.5%
12/22
|
45.0%
9/20
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.0%
2/20
|
22.7%
5/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
DYSPHAGIA
|
10.0%
2/20
|
9.1%
2/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
GASTRITIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
FLATULENCE
|
5.0%
1/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
STOMATITIS
|
20.0%
4/20
|
18.2%
4/22
|
25.0%
5/20
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.0%
5/20
|
31.8%
7/22
|
60.0%
12/20
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
LIP SWELLING
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.0%
1/20
|
13.6%
3/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
NEUTROPENIC COLITIS
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/20
|
9.1%
2/22
|
0.00%
0/20
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Infections and infestations
INFECTION
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Infections and infestations
SINUSITIS
|
5.0%
1/20
|
4.5%
1/22
|
10.0%
2/20
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Infections and infestations
CANDIDIASIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Infections and infestations
NAIL INFECTION
|
5.0%
1/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Infections and infestations
ORAL CANDIDIASIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Infections and infestations
LOCALISED INFECTION
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.0%
1/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Infections and infestations
NAIL BED INFECTION FUNGAL
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/20
|
0.00%
0/22
|
10.0%
2/20
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/20
|
18.2%
4/22
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
10.0%
2/20
|
27.3%
6/22
|
20.0%
4/20
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
5.0%
1/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/20
|
9.1%
2/22
|
10.0%
2/20
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
10.0%
2/20
|
4.5%
1/22
|
15.0%
3/20
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
5.0%
1/20
|
9.1%
2/22
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
30.0%
6/20
|
31.8%
7/22
|
30.0%
6/20
|
|
Blood and lymphatic system disorders
ANAEMIA
|
20.0%
4/20
|
27.3%
6/22
|
10.0%
2/20
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
30.0%
6/20
|
9.1%
2/22
|
15.0%
3/20
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
15.0%
3/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
55.0%
11/20
|
22.7%
5/22
|
25.0%
5/20
|
|
Blood and lymphatic system disorders
MONOCYTOPENIA
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
10.0%
2/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
RASH
|
10.0%
2/20
|
18.2%
4/22
|
10.0%
2/20
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
20.0%
4/20
|
45.5%
10/22
|
30.0%
6/20
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
10.0%
2/20
|
4.5%
1/22
|
10.0%
2/20
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.0%
1/20
|
9.1%
2/22
|
10.0%
2/20
|
|
Skin and subcutaneous tissue disorders
KOILONYCHIA
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
ONYCHOCLASIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
20.0%
4/20
|
9.1%
2/22
|
15.0%
3/20
|
|
Skin and subcutaneous tissue disorders
ONYCHOMADESIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
PALMAR ERYTHEMA
|
5.0%
1/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
EXFOLIATIVE RASH
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
10.0%
2/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
5.0%
1/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
40.0%
8/20
|
54.5%
12/22
|
40.0%
8/20
|
|
Reproductive system and breast disorders
BREAST DISCHARGE
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Reproductive system and breast disorders
PELVIC HAEMATOMA
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Reproductive system and breast disorders
MENSTRUATION IRREGULAR
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
WOUND SECRETION
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/20
|
13.6%
3/22
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.0%
1/20
|
13.6%
3/22
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
10.0%
2/20
|
4.5%
1/22
|
10.0%
2/20
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
15.0%
3/20
|
13.6%
3/22
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
15.0%
3/20
|
4.5%
1/22
|
25.0%
5/20
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.0%
1/20
|
13.6%
3/22
|
15.0%
3/20
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.0%
3/20
|
13.6%
3/22
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
15.0%
3/20
|
18.2%
4/22
|
20.0%
4/20
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/20
|
4.5%
1/22
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
5.0%
1/20
|
4.5%
1/22
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
5.0%
1/20
|
13.6%
3/22
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/20
|
4.5%
1/22
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
10.0%
2/20
|
0.00%
0/22
|
0.00%
0/20
|
|
General disorders
PAIN
|
15.0%
3/20
|
9.1%
2/22
|
5.0%
1/20
|
|
General disorders
CHILLS
|
5.0%
1/20
|
9.1%
2/22
|
0.00%
0/20
|
|
General disorders
OEDEMA
|
5.0%
1/20
|
0.00%
0/22
|
5.0%
1/20
|
|
General disorders
FATIGUE
|
60.0%
12/20
|
77.3%
17/22
|
75.0%
15/20
|
|
General disorders
PYREXIA
|
25.0%
5/20
|
4.5%
1/22
|
15.0%
3/20
|
|
General disorders
XEROSIS
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
General disorders
ASTHENIA
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
General disorders
FIBROSIS
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
General disorders
CHEST PAIN
|
5.0%
1/20
|
4.5%
1/22
|
5.0%
1/20
|
|
General disorders
OEDEMA PERIPHERAL
|
10.0%
2/20
|
22.7%
5/22
|
20.0%
4/20
|
|
General disorders
CATHETER SITE PAIN
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
General disorders
CATHETER THROMBOSIS
|
0.00%
0/20
|
0.00%
0/22
|
5.0%
1/20
|
|
General disorders
MUCOSAL INFLAMMATION
|
30.0%
6/20
|
13.6%
3/22
|
15.0%
3/20
|
|
General disorders
CATHETER SITE ERYTHEMA
|
5.0%
1/20
|
0.00%
0/22
|
0.00%
0/20
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
5.0%
1/20
|
4.5%
1/22
|
0.00%
0/20
|
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