Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.
Interventions
DRUGIxabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL
On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
DRUGIxabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m\^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
Sponsors
R-Pharm
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥20 years * Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC) * Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage IV, or recurrent * No prior chemotherapy-containing regimens for the treatment of NSCLC * Eastern Cooperative Oncology Group performance status of 0-1 * Life expectancy of at least 12 weeks * Accessible for treatment and follow up; patients who could be hospitalized for first 15 days of Cycle 1 * Adequate recovery from previous systemic therapy (at least 3 weeks for surgery or radiation therapy)
Exclusion criteria
* Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug * Women pregnant or breast feeding * Women with a positive pregnancy test result on enrollment or prior to study drug administration * Sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are WOCBP * Patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases * Prior radiation must not have included ≥30% of major bone-marrow-containing areas (pelvis, lumbar spine) * Common Terminology Criteria (CTC) Grade 2 or greater neuropathy * Psychiatric or other disorders rendering the patient incapable of complying with protocol requirements * Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix (Patients with a history of malignancy but without evidence of disease for 5 years are eligible) * Serious uncontrolled medical disorder or active systemic infection that would impair the ability of the subject to receive protocol therapy. * Myocardial infarction, unstable angina, or unstable congestive heart failure within 6 months * Known history of infection with human immunodeficiency virus * Inadequate bone marrow function * Inadequate hepatic function * Inadequate renal function * Known prior severe hypersensitivity reaction (CTC Grade 2 or greater) to agents containing Cremophor®EL * Known severe hypersensitivity reaction to agents containing carboplatin and other platinum * Prior treatment with an epothilone and/or with platinum * History of high-dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within 2 years * On treatment with strong Cytochrome P450 3A4 inhibitor * Current imprisonment * Compulsorily detention for treatment of psychiatric or physical illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose-limiting Toxicity (DLT) | Days 1 through 21 (Cycle 1) | DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (\<25,000 cells/mm\^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. |
| Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 | Days 1 through 21 (Cycle 1) | The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | At screening and Days 8 and 15 of Cycle 1 (21 days) | LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (\*10\^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (\*10\^3 c/uL); neutrophils (absolute), neutrophils + bands (\*10\^3 c/uL); platelet count (\*10\^9 c/L; LLN=131; ULN=365) Appendix 7.1.2 |
| Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | At screening and Days 8 and 15 of Cycle 1 (21 days) | ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L) |
| Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | At screening and Days 8 and 15 of Cycle 1 (21 days) | Toxicities graded according to CTC, Version 3. Protein Gr 1: \<1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: \>=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry. |
| Number of Participants With Abnormalities in Blood Pressure and Heart Rate | At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) | Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE. |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) | — |
| Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | Days 1 through 21 (Cycle 1) | 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 inpatient hospitalization or prolongs existing hospitalization. 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. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug. |
| Total Body Clearance of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) | — |
| Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) | Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes \>10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair. |
| Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | Days 1 through 21 (Cycle 1) | Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met. |
| Maximum Observed Plasma Concentration of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) | — |
| Time of Maximum Observed Plasma Concentration of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) | — |
| Volume of Distribution at Steady State of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) | — |
| Number of Participants With Grade 3 or Greater Treatment-related AEs | Days 1 through 21 (Cycle 1) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug. |
Countries
Japan
Participant flow
Pre-assignment details
After all participants in Dose Level 1 (ixabepilone, 32 mg/m\^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2 (ixabepilone, 32 mg/m\^2 + carboplatin, 6 mg/min/mL) opened.
Participants by arm
| Arm | Count |
|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion; 30 minutes after infusion completion, carboplatin, 5 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | 6 |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL Ixabepilone, 32 mg/m\^2, administered as a 3-hour infusion; 30 minutes after infusion completion, carboplatin, 6 mg/min/mL, infused over 30 minutes on Day 1 of each 21-day cycle. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Dose Level 1 | Adverse Event | 1 | 0 |
| Dose Level 1 | Disease progression | 2 | 0 |
| Dose Level 2 | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Continuous | 51.2 years STANDARD_DEVIATION 8.3 | 57.7 years STANDARD_DEVIATION 10.5 | 54.4 years STANDARD_DEVIATION 9.62 |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Japanese | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2
The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.
Time frame: Days 1 through 21 (Cycle 1)
Population: All participants who received at least 1 dose of either ixabepilone or carboplatin
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 | 6 mg/min/mL |
Primary
Number of Participants With Dose-limiting Toxicity (DLT)
DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (\<25,000 cells/mm\^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.
Time frame: Days 1 through 21 (Cycle 1)
Population: All participants who received at least 1 dose of either ixabepilone or carboplatin
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Dose-limiting Toxicity (DLT) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Dose-limiting Toxicity (DLT) | 1 Participants |
Secondary
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone | 1542.11 ng*h/mL | Standard Deviation 585.29 |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone | 2135.93 ng*h/mL | Standard Deviation 1246.08 |
Secondary
Maximum Observed Plasma Concentration of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Maximum Observed Plasma Concentration of Ixabepilone | 195.77 ng/mL | Standard Deviation 45.89 |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Maximum Observed Plasma Concentration of Ixabepilone | 250.32 ng/mL | Standard Deviation 76.17 |
Secondary
Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met.
Time frame: Days 1 through 21 (Cycle 1)
Population: All treated participants with measurable disease at baseline, as determined by investigator
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | PR | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | SD | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | PD | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | Unable to be assessed (patient discontinuation) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | CR | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | Unable to be assessed (patient discontinuation) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | CR | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | PR | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | PD | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | SD | 4 Participants |
Secondary
Number of Participants With Abnormalities in Blood Pressure and Heart Rate
Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE.
Time frame: At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Blood Pressure and Heart Rate | Blood pressure | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Blood Pressure and Heart Rate | Heart rate | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Blood Pressure and Heart Rate | Blood pressure | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Blood Pressure and Heart Rate | Heart rate | 0 Participants |
Secondary
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (\*10\^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (\*10\^3 c/uL); neutrophils (absolute), neutrophils + bands (\*10\^3 c/uL); platelet count (\*10\^9 c/L; LLN=131; ULN=365) Appendix 7.1.2
Time frame: At screening and Days 8 and 15 of Cycle 1 (21 days)
Population: All participants who received at least 1 dose of either ixabepilone or carboplatin
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes (absolute): Grade 3 (0.2-<0.5) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Grade 2 (1.0-<1.5) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes (absolute): Grade 4 (<0.2) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Grade 1 (3.0-<LLN) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes: Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Grade 4 (<6.5) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Grade 1 (1.5-<2.0) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Grade 2 (2.0-<3.0) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Grade 3 (0.5-<1.0) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Grade 3 (1.0-<2.0) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Grade 4 (<0.5) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Grade 2 (8.0-<10.0) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Grade 4 (<1.0) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Grade 1 (1.5-<2.0) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Grade 3 (0.5-<1.0) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Grade 2 (1.0-<1.5) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Grade 4 (<0.5) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Grade 3 (6.5-<8.0) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes (absolute): Grade 1 (0.8-<1.5) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Grade 1 (75.0-<LLN) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Grade 2 (50.0-<75.0) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes (absolute): Grade 2 (0.5-<0.8) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Grade 3 (25.0-<50.0) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Grade 4 (<25.0) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Grade 1 (10.0- LLN) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Grade 4 (<25.0) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Grade 1 (10.0- LLN) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Grade 4 (<6.5) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Grade 1 (1.5-<2.0) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Grade 2 (1.0-<1.5) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Grade 2 (2.0-<3.0) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Grade 2 (8.0-<10.0) | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Grade 3 (6.5-<8.0) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Hemoglobin: Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Grade 1 (3.0-<LLN) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Grade 3 (1.0-<2.0) | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Grade 4 (<1.0) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Leukocytes: Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes (absolute): Grade 1 (0.8-<1.5) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes (absolute): Grade 2 (0.5-<0.8) | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes (absolute): Grade 3 (0.2-<0.5) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes (absolute): Grade 4 (<0.2) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Lymphocytes: Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Grade 2 (1.0-<1.5) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Grade 3 (0.5-<1.0) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Grade 4 (<0.5) | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils (absolute): Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Grade 1 (1.5-<2.0) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Grade 3 (0.5-<1.0) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Grade 4 (<0.5) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Neutrophils+bands (absolute): Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Grade 1 (75.0-<LLN) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Grade 2 (50.0-<75.0) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | Platelet count: Grade 3 (25.0-<50.0) | 1 Participants |
Secondary
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L)
Time frame: At screening and Days 8 and 15 of Cycle 1 (21 days)
Population: All participants who received at least 1 dose of either ixabepilone or carboplatin
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | AST: Grade 2 (>2.5-5.0*ULN) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ALT: Grade 1 ( >1.0-2.5*ULN) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Bilirubin: Grade 1 (>1.0-1.5*ULN) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Albumin: Grade 1 (<LLN-3.0) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Bilirubin: Grade 2 (>1.5-3.0*ULN) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ALT: Grade 2 (>2.5-5.0*ULN) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Calcium: Grade 1 (8.0-<LLN or >ULN -11.5) | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ALP: Grade 1 ( >1.0-2.5*ULN) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Creatinine: Grade 1 (>1.0-1.5*ULN) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Potassium: Grade 1 (3.0-<LLN or >ULN-5.5) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | AST: Grade 1 ( >1.0-2.5*ULN) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Sodium: Grade 1 (130-<LLN or >ULN-150) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ALT: Grade 3 ( >5.0-20.0*ULN ) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Sodium: Grade 1 (130-<LLN or >ULN-150) | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ALT: Grade 2 (>2.5-5.0*ULN) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ALT: Grade 3 ( >5.0-20.0*ULN ) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Albumin: Grade 1 (<LLN-3.0) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ALP: Grade 1 ( >1.0-2.5*ULN) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | AST: Grade 1 ( >1.0-2.5*ULN) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | AST: Grade 2 (>2.5-5.0*ULN) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Bilirubin: Grade 1 (>1.0-1.5*ULN) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Bilirubin: Grade 2 (>1.5-3.0*ULN) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Calcium: Grade 1 (8.0-<LLN or >ULN -11.5) | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Creatinine: Grade 1 (>1.0-1.5*ULN) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | Potassium: Grade 1 (3.0-<LLN or >ULN-5.5) | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ALT: Grade 1 ( >1.0-2.5*ULN) | 2 Participants |
Secondary
Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
Toxicities graded according to CTC, Version 3. Protein Gr 1: \<1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: \>=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry.
Time frame: At screening and Days 8 and 15 of Cycle 1 (21 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Protein (Grade 4) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Protein (Grade 1) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Protein (Grade 2) | 3 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Protein (Grade 3) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Not reported | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Protein (Grade 3) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Protein (Grade 1) | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Protein (Grade 4) | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Protein (Grade 2) | 0 Participants |
Secondary
Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status
Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes \>10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair.
Time frame: At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | Blood pressure | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | Heart rate | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | Weight | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | Blood pressure | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | Weight | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | Heart rate | 0 Participants |
Secondary
Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation
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 inpatient hospitalization or prolongs existing hospitalization. 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. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.
Time frame: Days 1 through 21 (Cycle 1)
Population: All participants who received at least 1 dose of either ixabepilone or carboplatin
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | Treatment-related SAEs | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | SAEs | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | AEs | 6 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | Treatment-related AEs leading to discontinuation | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | Death | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | Treatment-related AEs leading to discontinuation | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | Death | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | Treatment-related SAEs | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | AEs | 6 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | SAEs | 0 Participants |
Secondary
Number of Participants With Grade 3 or Greater Treatment-related AEs
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.
Time frame: Days 1 through 21 (Cycle 1)
Population: All subjects who received at least 1 dose of either ixabepilone or carboplatin
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Neutropenia | 5 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Leukopenia | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Anemia | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Liver function test abnormality | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Deep vein thrombosis | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Thrombocytopenia | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Lymphopenia | 2 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Nausea | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Nausea | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Neutropenia | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Deep vein thrombosis | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Leukopenia | 4 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Lymphopenia | 0 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Anemia | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Thrombocytopenia | 1 Participants |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Number of Participants With Grade 3 or Greater Treatment-related AEs | Liver function test abnormality | 1 Participants |
Secondary
Time of Maximum Observed Plasma Concentration of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Time of Maximum Observed Plasma Concentration of Ixabepilone | 2.61 Hours | Standard Deviation 0.88 |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Time of Maximum Observed Plasma Concentration of Ixabepilone | 2.43 Hours | Standard Deviation 1.03 |
Secondary
Total Body Clearance of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Total Body Clearance of Ixabepilone | 33.64 Liters/hour | Standard Deviation 11 |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Total Body Clearance of Ixabepilone | 25.20 Liters/hour | Standard Deviation 8 |
Secondary
Volume of Distribution at Steady State of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL | Volume of Distribution at Steady State of Ixabepilone | 1131.02 Liters | Standard Deviation 373 |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL | Volume of Distribution at Steady State of Ixabepilone | 1122.82 Liters | Standard Deviation 477 |