Trial Outcomes & Findings for Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer (NCT NCT00683904)
NCT ID: NCT00683904
Last Updated: 2016-03-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Days 1 through 21 (Cycle 1)
Results posted on
2016-03-10
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: 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.
|
|---|---|---|
|
Dose Level 1
STARTED
|
6
|
0
|
|
Dose Level 1
COMPLETED
|
3
|
0
|
|
Dose Level 1
NOT COMPLETED
|
3
|
0
|
|
Dose Level 2
STARTED
|
0
|
6
|
|
Dose Level 2
COMPLETED
|
0
|
4
|
|
Dose Level 2
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
After all participants in Dose Level 1 have been observed for 1 full 21-day cycle, Dose Level 2 opened: 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.
|
|---|---|---|
|
Dose Level 1
Disease progression
|
2
|
0
|
|
Dose Level 1
Adverse Event
|
1
|
0
|
|
Dose Level 2
Adverse Event
|
0
|
2
|
Baseline Characteristics
Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
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.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 21 (Cycle 1)Population: All participants who received at least 1 dose of either ixabepilone or carboplatin
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.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants With Dose-limiting Toxicity (DLT)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 21 (Cycle 1)Population: All participants who received at least 1 dose of either ixabepilone or carboplatin
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.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=12 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2
|
6 mg/min/mL
|
—
|
SECONDARY outcome
Timeframe: Days 1 through 21 (Cycle 1)Population: All participants who received at least 1 dose of either ixabepilone or carboplatin
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.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
6 Participants
|
|
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
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 21 (Cycle 1)Population: All subjects who received at least 1 dose of either ixabepilone or carboplatin
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.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants With Grade 3 or Greater Treatment-related AEs
Thrombocytopenia
|
2 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Greater Treatment-related AEs
Neutropenia
|
5 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 or Greater Treatment-related AEs
Leukopenia
|
4 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 or Greater Treatment-related AEs
Anemia
|
4 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Greater Treatment-related AEs
Lymphopenia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Greater Treatment-related AEs
Nausea
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Greater Treatment-related AEs
Liver function test abnormality
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or Greater Treatment-related AEs
Deep vein thrombosis
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Lymphocytes: Not reported
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils (absolute): Grade 1 (1.5-<2.0)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Platelet count: Grade 1 (75.0-<LLN)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Platelet count: Grade 2 (50.0-<75.0)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Leukocytes: Grade 4 (<1.0)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Leukocytes: Not reported
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Hemoglobin: Grade 1 (10.0- LLN)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Hemoglobin: Grade 2 (8.0-<10.0)
|
2 Participants
|
5 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Hemoglobin: Grade 3 (6.5-<8.0)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Hemoglobin: Grade 4 (<6.5)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Hemoglobin: Not reported
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Leukocytes: Grade 1 (3.0-<LLN)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Leukocytes: Grade 2 (2.0-<3.0)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Leukocytes: Grade 3 (1.0-<2.0)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Lymphocytes (absolute): Grade 1 (0.8-<1.5)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Lymphocytes (absolute): Grade 2 (0.5-<0.8)
|
0 Participants
|
5 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Lymphocytes (absolute): Grade 3 (0.2-<0.5)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Lymphocytes (absolute): Grade 4 (<0.2)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils (absolute): Grade 2 (1.0-<1.5)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils (absolute): Grade 3 (0.5-<1.0)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils (absolute): Grade 4 (<0.5)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils (absolute): Not reported
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils+bands (absolute): Grade 1 (1.5-<2.0)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils+bands (absolute): Grade 2 (1.0-<1.5)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils+bands (absolute): Grade 3 (0.5-<1.0)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils+bands (absolute): Grade 4 (<0.5)
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Neutrophils+bands (absolute): Not reported
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Platelet count: Grade 3 (25.0-<50.0)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Platelet count: Grade 4 (<25.0)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Platelet count: Not reported
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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
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)
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
Albumin: Grade 1 (<LLN-3.0)
|
4 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
ALP: Grade 1 ( >1.0-2.5*ULN)
|
0 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
ALT: Grade 1 ( >1.0-2.5*ULN)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
ALT: Grade 2 (>2.5-5.0*ULN)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
ALT: Grade 3 ( >5.0-20.0*ULN )
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
AST: Grade 1 ( >1.0-2.5*ULN)
|
4 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
AST: Grade 2 (>2.5-5.0*ULN)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
Bilirubin: Grade 1 (>1.0-1.5*ULN)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
Bilirubin: Grade 2 (>1.5-3.0*ULN)
|
1 Participants
|
0 Participants
|
|
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
|
4 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
Creatinine: Grade 1 (>1.0-1.5*ULN)
|
0 Participants
|
2 Participants
|
|
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
|
1 Participants
|
|
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
Sodium: Grade 1 (130-<LLN or >ULN-150)
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
Not reported
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
Protein (Grade 1)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
Protein (Grade 2)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
Protein (Grade 3)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
Protein (Grade 4)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants With Abnormalities in Blood Pressure and Heart Rate
Blood pressure
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Blood Pressure and Heart Rate
Heart rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status
Heart rate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status
Weight
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status
Blood pressure
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 21 (Cycle 1)Population: All treated participants with measurable disease at baseline, as determined by investigator
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.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=4 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
Unable to be assessed (patient discontinuation)
|
0 Participants
|
1 Participants
|
|
Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
CR
|
0 Participants
|
0 Participants
|
|
Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
PR
|
2 Participants
|
1 Participants
|
|
Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
PD
|
2 Participants
|
0 Participants
|
|
Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
SD
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 1 to 8 of Cycle 1 (21 days)Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Maximum Observed Plasma Concentration of Ixabepilone
|
195.77 ng/mL
Standard Deviation 45.89
|
250.32 ng/mL
Standard Deviation 76.17
|
SECONDARY outcome
Timeframe: Days 1 to 8 of Cycle 1 (21 days)Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Time of Maximum Observed Plasma Concentration of Ixabepilone
|
2.61 Hours
Standard Deviation 0.88
|
2.43 Hours
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Days 1 to 8 of Cycle 1 (21 days)Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
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
|
2135.93 ng*h/mL
Standard Deviation 1246.08
|
SECONDARY outcome
Timeframe: Days 1 to 8 of Cycle 1 (21 days)Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Volume of Distribution at Steady State of Ixabepilone
|
1131.02 Liters
Standard Deviation 373
|
1122.82 Liters
Standard Deviation 477
|
SECONDARY outcome
Timeframe: Days 1 to 8 of Cycle 1 (21 days)Population: All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL
n=6 Participants
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Total Body Clearance of Ixabepilone
|
33.64 Liters/hour
Standard Deviation 11
|
25.20 Liters/hour
Standard Deviation 8
|
Adverse Events
Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL
n=6 participants at risk
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL
n=6 participants at risk
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Vascular disorders
SUPERIOR VENA CAVAL OCCLUSION
|
16.7%
1/6
|
0.00%
0/6
|
Other adverse events
| Measure |
Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL
n=6 participants at risk
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL
n=6 participants at risk
Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle.
|
|---|---|---|
|
Eye disorders
Asthenopia
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Protein urine
|
83.3%
5/6
|
16.7%
1/6
|
|
Investigations
Weight decreased
|
16.7%
1/6
|
50.0%
3/6
|
|
Investigations
Blood urine present
|
50.0%
3/6
|
50.0%
3/6
|
|
Investigations
Glucose urine present
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6
|
50.0%
3/6
|
|
Investigations
Blood sodium increased
|
16.7%
1/6
|
0.00%
0/6
|
|
Investigations
Blood albumin decreased
|
33.3%
2/6
|
16.7%
1/6
|
|
Investigations
Protein total decreased
|
16.7%
1/6
|
0.00%
0/6
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6
|
16.7%
1/6
|
|
Investigations
Blood potassium increased
|
33.3%
2/6
|
0.00%
0/6
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6
|
16.7%
1/6
|
|
Investigations
Liver function test abnormal
|
16.7%
1/6
|
33.3%
2/6
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
4/6
|
33.3%
2/6
|
|
Investigations
Aspartate aminotransferase increased
|
83.3%
5/6
|
50.0%
3/6
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6
|
16.7%
1/6
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6
|
0.00%
0/6
|
|
Vascular disorders
Haemorrhage
|
16.7%
1/6
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
|
16.7%
1/6
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
16.7%
1/6
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6
|
16.7%
1/6
|
|
Vascular disorders
Superior vena caval occlusion
|
16.7%
1/6
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6
|
0.00%
0/6
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6
|
16.7%
1/6
|
|
Psychiatric disorders
Sleep disorder
|
16.7%
1/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
16.7%
1/6
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6
|
0.00%
0/6
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6
|
66.7%
4/6
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6
|
16.7%
1/6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
6/6
|
83.3%
5/6
|
|
Gastrointestinal disorders
Nausea
|
100.0%
6/6
|
100.0%
6/6
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6
|
50.0%
3/6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
33.3%
2/6
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
3/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Constipation
|
83.3%
5/6
|
33.3%
2/6
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6
|
16.7%
1/6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6
|
0.00%
0/6
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
16.7%
1/6
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Glycosuria
|
16.7%
1/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Pollakiuria
|
16.7%
1/6
|
0.00%
0/6
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
6/6
|
83.3%
5/6
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
6/6
|
100.0%
6/6
|
|
Blood and lymphatic system disorders
Leukopenia
|
100.0%
6/6
|
100.0%
6/6
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
2/6
|
66.7%
4/6
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
6/6
|
100.0%
6/6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
6/6
|
100.0%
6/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
3/6
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
6/6
|
83.3%
5/6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
6/6
|
100.0%
6/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
6/6
|
83.3%
5/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6
|
33.3%
2/6
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6
|
16.7%
1/6
|
|
General disorders
Oedema
|
16.7%
1/6
|
0.00%
0/6
|
|
General disorders
Fatigue
|
83.3%
5/6
|
66.7%
4/6
|
|
General disorders
Malaise
|
16.7%
1/6
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
16.7%
1/6
|
16.7%
1/6
|
|
General disorders
Injection site reaction
|
16.7%
1/6
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
16.7%
1/6
|
0.00%
0/6
|
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