Metastatic Breast Cancer
Conditions
Brief summary
The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.
Interventions
DRUGIxabepilone
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
Sponsors
R-Pharm
US Oncology Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) ≥ 50 * Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer * Prior chemotherapy is permitted with no limit on the number of prior regimens * Two weeks or more have elapsed since last chemotherapy or radiation treatment * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 * Is female, ≥ 18 yrs of age * Protocol defined appropriate laboratory values * Negative pregnancy test within 7 calendar days prior to registration * Has signed a patient informed consent
Exclusion criteria
* Had prior treatment with ixabepilone or other epothilones * Has HER2+ disease * Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events \[NCI CTCAE\] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil) * Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy * Is receiving concurrent investigational therapy or has received such therapy within the past 30 days * Has peripheral neuropathy \> Grade 1 * Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible * Is pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months | From the date of randomization to 6-months on study | PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Progression Free Survival | From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months) | PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375. |
| Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST] | Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months) | ORR is defined as the proportion of responders (complete response \[CR\] + partial response \[PR\] in participants with measurable disease) in that arm among all randomized participants. CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography \[CT\], magnetic resonance imaging \[MRI\], X-ray) or as ≥10 mm with spiral CT scan. |
| Overall Survival (OS) | From the date of randomization to date of death (maximum participant OS of 26.3 months) | Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm. Survival time (months) = (End date - date of randomization + 1)/30.4375 |
| Time to Response | From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months) | Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR. CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD. |
| Duration of Response | From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months) | Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD. |
| Incidence of All Grades of Peripheral Neuropathy | Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm). | All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included. |
| Best Response as Assessed With RECIST | Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months) | Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm). | 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, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade. |
Countries
United States
Participant flow
Recruitment details
A total of 176 participants were enrolled by 55 sites in the United States over a period of 12 months.
Pre-assignment details
All the 176 enrolled participants were randomized. Of the 5 participants who did not receive treatment, 2 were due to disease progression, 1 on participant request, and 2 due to other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Ixabepilone 16 mg/m^2 ixabepilone 16 mg/m\^2 weekly for 3 weeks followed by 1 week rest | 85 |
| Ixabepilone 40 mg/m^2 ixabepilone 40 mg/m\^2 every 3 weeks | 91 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | On Active Treatment/Pending | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Ixabepilone 40 mg/m^2 | Ixabepilone 16 mg/m^2 |
|---|---|---|---|
| Age, Continuous | 59.5 Years STANDARD_DEVIATION 10.9 | 58.7 Years STANDARD_DEVIATION 10.4 | 60.3 Years STANDARD_DEVIATION 11.4 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0=normal activity | 82 Participants | 43 Participants | 39 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1=symptoms, but fully ambulatory | 83 Participants | 43 Participants | 40 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 2=symptomatic, but in bed < 50% of the day | 11 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized African American | 19 Participants | 10 Participants | 9 Participants |
| Race/Ethnicity, Customized Caucasian | 139 Participants | 70 Participants | 69 Participants |
| Race/Ethnicity, Customized Hispanic | 17 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 176 Participants | 91 Participants | 85 Participants |
| Sex: Female, Male Female | 176 Participants | 91 Participants | 85 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 82 / 82 | 89 / 89 |
| serious Total, serious adverse events | 25 / 82 | 30 / 89 |
Outcome results
Primary
Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months
PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.
Time frame: From the date of randomization to 6-months on study
Population: ITT population: Participants who were randomized on the study (eligible and ineligible).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone 16 mg/m^2 | Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months | 28.6 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months | 42.7 Percentage of Participants |
p-value: 0.03Log Rank
Secondary
Best Response as Assessed With RECIST
Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.
Time frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
Population: Evaluable population: All treated participants with CR, PR, SD, PD, or NE response and who had received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone 16 mg/m^2 | Best Response as Assessed With RECIST | SD | 40.5 Percentage of Participants |
| Ixabepilone 16 mg/m^2 | Best Response as Assessed With RECIST | PD | 41.8 Percentage of Participants |
| Ixabepilone 16 mg/m^2 | Best Response as Assessed With RECIST | PR | 7.6 Percentage of Participants |
| Ixabepilone 16 mg/m^2 | Best Response as Assessed With RECIST | NE | 10.1 Percentage of Participants |
| Ixabepilone 16 mg/m^2 | Best Response as Assessed With RECIST | SD>=6 months | 19.0 Percentage of Participants |
| Ixabepilone 16 mg/m^2 | Best Response as Assessed With RECIST | CR+PR+SD>=6 mos | 26.6 Percentage of Participants |
| Ixabepilone 16 mg/m^2 | Best Response as Assessed With RECIST | CR | 0 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Best Response as Assessed With RECIST | CR+PR+SD>=6 mos | 29.2 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Best Response as Assessed With RECIST | CR | 1.1 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Best Response as Assessed With RECIST | PR | 12.4 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Best Response as Assessed With RECIST | SD | 44.9 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Best Response as Assessed With RECIST | SD>=6 months | 15.7 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Best Response as Assessed With RECIST | PD | 29.2 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Best Response as Assessed With RECIST | NE | 12.4 Percentage of Participants |
Secondary
Duration of Response
Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.
Time frame: From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)
Population: ITT population with CR or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixabepilone 16 mg/m^2 | Duration of Response | 6.2 Months |
| Ixabepilone 40 mg/m^2 | Duration of Response | 6.3 Months |
Secondary
Incidence of All Grades of Peripheral Neuropathy
All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.
Time frame: Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).
Population: Safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone 16 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | Grade 3 | 6 Participants |
| Ixabepilone 16 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | All | 26 Participants |
| Ixabepilone 16 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | Grade 1 | 9 Participants |
| Ixabepilone 16 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | Grade 2 | 10 Participants |
| Ixabepilone 16 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | Grade 4 | 1 Participants |
| Ixabepilone 40 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | Grade 4 | 0 Participants |
| Ixabepilone 40 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | Grade 2 | 10 Participants |
| Ixabepilone 40 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | All | 39 Participants |
| Ixabepilone 40 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | Grade 3 | 14 Participants |
| Ixabepilone 40 mg/m^2 | Incidence of All Grades of Peripheral Neuropathy | Grade 1 | 15 Participants |
Secondary
Median Progression Free Survival
PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375.
Time frame: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)
Population: ITT population: Participants who were randomized on the study (eligible and ineligible).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixabepilone 16 mg/m^2 | Median Progression Free Survival | 2.9 Months |
| Ixabepilone 40 mg/m^2 | Median Progression Free Survival | 5.3 Months |
p-value: 0.05Log Rank
Secondary
Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]
ORR is defined as the proportion of responders (complete response \[CR\] + partial response \[PR\] in participants with measurable disease) in that arm among all randomized participants. CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography \[CT\], magnetic resonance imaging \[MRI\], X-ray) or as ≥10 mm with spiral CT scan.
Time frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
Population: Evaluable population-All treated participants with CR, PR, stable disease (SD), progressive disease (PD), or nonevaluable (NE) response and who had received at least 1 dose of study drug. Please refer outcome measure 4 for explanation of SD, PD, and NE.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone 16 mg/m^2 | Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST] | 7.6 Percentage of Participants |
| Ixabepilone 40 mg/m^2 | Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST] | 13.5 Percentage of Participants |
Secondary
Overall Survival (OS)
Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm. Survival time (months) = (End date - date of randomization + 1)/30.4375
Time frame: From the date of randomization to date of death (maximum participant OS of 26.3 months)
Population: ITT population: Participants who were randomized on the study (eligible and ineligible).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixabepilone 16 mg/m^2 | Overall Survival (OS) | 13.9 Months |
| Ixabepilone 40 mg/m^2 | Overall Survival (OS) | 16.1 Months |
p-value: 0.11Log Rank
Secondary
Time to Response
Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR. CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD.
Time frame: From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)
Population: ITT population with CR or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixabepilone 16 mg/m^2 | Time to Response | 2.5 Months |
| Ixabepilone 40 mg/m^2 | Time to Response | 2.8 Months |
Other Pre-specified
Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia
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, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. GR=Grade.
Time frame: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).
Population: ITT population: Participants randomized on the study (eligible and ineligible). AEs, AEs leading to death and GR 3-4 AEs: Safety population-Participants who received atleast 1 dose of study drug).~AEs leading to death: For 4 participants in Arm 1 and both participants in Arm 2, the reported AE term was disease progression.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Deaths (All) | 55 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Treatment-related deaths | 0 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | AEs leading to death (n=82; n=89) | 7 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 SAE | 25 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 study-related SAE | 5 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | AEs leading to discontinuation | 15 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 AE (n=82; n=89) | 82 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 study-related AEs | 69 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 GR 3 and 4 AEs (n=82; n=89) | 34 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 study-related GR 3 and 4 AEs | 23 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Drug-related peripheral neuropathy (All) | 26 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 1 and 2 drug-related peripheral neuropathy | 19 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 3 drug-related peripheral neuropathy | 6 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 4 drug-related peripheral neuropathy | 1 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Drug-related neutropenia (All) | 15 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 1 and 2 drug-related neutropenia | 10 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 3 drug-related neutropenia | 3 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 4 drug-related neutropenia | 2 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Drug-related alopecia (All) | 21 Participants |
| Ixabepilone 16 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 1 and 2 drug-related alopecia | 21 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 4 drug-related neutropenia | 16 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Deaths (All) | 48 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Drug-related peripheral neuropathy (All) | 38 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Treatment-related deaths | 0 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 1 and 2 drug-related neutropenia | 13 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | AEs leading to death (n=82; n=89) | 2 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 1 and 2 drug-related peripheral neuropathy | 24 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 SAE | 30 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 1 and 2 drug-related alopecia | 54 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 study-related SAE | 17 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 3 drug-related peripheral neuropathy | 14 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | AEs leading to discontinuation | 30 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 3 drug-related neutropenia | 18 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 AE (n=82; n=89) | 89 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | GR 4 drug-related peripheral neuropathy | 0 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 study-related AEs | 84 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Drug-related alopecia (All) | 54 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 GR 3 and 4 AEs (n=82; n=89) | 69 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | Drug-related neutropenia (All) | 47 Participants |
| Ixabepilone 40 mg/m^2 | Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia | At least 1 study-related GR 3 and 4 AEs | 61 Participants |