Trial Outcomes & Findings for A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer (NCT NCT00723957)
NCT ID: NCT00723957
Last Updated: 2020-10-28
Results Overview
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
Randomization to disease progression or death (maximum reached: 14.39 months )
Results posted on
2020-10-28
Participant Flow
Of 260 participants enrolled, 197 were randomized. Among those randomized, 191 received treatment.
Participant milestones
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
99
|
|
Overall Study
COMPLETED
|
47
|
46
|
|
Overall Study
NOT COMPLETED
|
51
|
53
|
Reasons for withdrawal
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Overall Study
Adverse event unrelated to study drug
|
1
|
4
|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Disease progression
|
27
|
25
|
|
Overall Study
Maximum clinical benefit
|
4
|
5
|
|
Overall Study
Investigator decision
|
1
|
1
|
|
Overall Study
Study drug toxicity
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
|
Overall Study
Reason not analyzed
|
1
|
0
|
|
Overall Study
Never received treatment
|
3
|
3
|
Baseline Characteristics
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=98 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=99 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Beta III (βIII)-tubulin positive tumors (n=53, 51)
|
60.0 Years
n=93 Participants
|
60.0 Years
n=4 Participants
|
60.0 Years
n=27 Participants
|
|
Age, Customized
βIII-tubulin negative tumors (N=45, 48)
|
60.0 Years
n=93 Participants
|
60.5 Years
n=4 Participants
|
60.0 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 participants
n=93 Participants
|
22 participants
n=4 Participants
|
52 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
68 participants
n=93 Participants
|
76 participants
n=4 Participants
|
144 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Number of participants with βIII-tubulin positive and negative tumors
βIII tubulin-positive tumors
|
53 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
|
Number of participants with βIII-tubulin positive and negative tumors
βIII tubulin-negative tumors
|
45 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Randomization to disease progression or death (maximum reached: 14.39 months )Population: All randomized participants with βIII-tubulin positive tumors and who received study drug
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=53 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=51 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors
|
4.27 Months
95% Confidence Interval NA • Interval 2.89 to 5.65
|
4.27 Months
95% Confidence Interval NA • Interval 3.61 to 6.05
|
SECONDARY outcome
Timeframe: Randomization to disease progression or death (maximum reached: 12.29 months)Population: All randomized participants who had βIII-tubulin positive tumors and who received study drug
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=45 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=48 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors
|
5.78 Months
95% Confidence Interval NA • Interval 5.29 to 8.41
|
5.32 Months
95% Confidence Interval NA • Interval 4.27 to 5.98
|
SECONDARY outcome
Timeframe: Randomization to disease progression or death, assessed to 12.29 monthsPopulation: All randomized participants who received study drug
Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=98 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=99 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Progression-free Survival in the Overall Population
|
5.29 Months
Interval 4.14 to 5.88
|
5.13 Months
Interval 4.21 to 5.78
|
SECONDARY outcome
Timeframe: At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cyclesResponse evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=98 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=99 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)
βIII-tubulin positive subgroup (n=53, n=51)
|
17.0 Percentage of participants
Interval 8.1 to 29.8
|
29.4 Percentage of participants
Interval 17.5 to 43.8
|
|
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)
βIII-tubulin negative subgroup (n=45, n=48)
|
26.7 Percentage of participants
Interval 14.6 to 41.9
|
27.1 Percentage of participants
Interval 15.3 to 41.8
|
|
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)
Overall population
|
21.4 Percentage of participants
Interval 13.8 to 30.9
|
28.3 Percentage of participants
Interval 19.7 to 38.2
|
SECONDARY outcome
Timeframe: Randomization to date of first response (PR or CR)Population: All randomized participants
Time to Response is defined as the time from randomization date until the date of first response (Partial Response \[PR\] or Complete Response \[CR\])
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=21 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=28 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Time to Response
Beta III positive (n=9, 15)
|
12.1 Weeks
Interval 5.1 to 19.3
|
6.6 Weeks
Interval 5.3 to 18.1
|
|
Time to Response
Beta III negative (n=12, 13)
|
9.5 Weeks
Interval 5.0 to 17.4
|
7.0 Weeks
Interval 5.1 to 12.9
|
|
Time to Response
Overall population
|
12.1 Weeks
Interval 5.0 to 19.3
|
6.6 Weeks
Interval 5.1 to 18.1
|
SECONDARY outcome
Timeframe: Days 1 through 21, continuouslyPopulation: All participants who received any investigational product.
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=96 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=95 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy
AEs Leading to Discontinuation
|
11 Participants
|
15 Participants
|
|
Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy
Death
|
28 Participants
|
34 Participants
|
|
Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy
Drug-related AEs
|
85 Participants
|
87 Participants
|
|
Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy
SAEs
|
27 Participants
|
28 Participants
|
|
Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy
Drug-related SAEs
|
15 Participants
|
9 Participants
|
|
Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy
Drug-related peripheral neuropathy
|
35 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: At screening and weekly during 21-day cyclePopulation: All participants who received any investigational product.
LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: \<LLN to 3.0\*10\^9/L, Grade 2:\<3.0 to 2.0\*10\^9/L, Grade 3: \<2.0 to 1.0\*10\^9/L, Grade 4: \<1.0\*10\^9/L; Neutrophils (neutropenia) Grade 1: \<LLN to 1.5\*10\^9/L, Grade 2: \<1.5 to 1.0\*10\^9/L, Grade 3: \<1.0 to 0.5\*10\^9/L, Grade 4: \<0.5\*10\^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0\*10\^9/L, Grade 2: \<75.0 to 50.0\*10\^9/L, Grade 3: \<50.0 to 25.0\*10\^9/L, Grade 4:\<25.0 to 10\^9/L; Hemoglobin (anemia) Grade 1: \<LLN to 10.0 g/dL, Grade 2: \<10.0 to 8.0 g/dL, Grade 3: \<8.0 to 6.5 g/dL, Grade 4: \<6.5 g/dL.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=96 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=95 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Number of Participants With Hematology Laboratory Results of Grade 3 or 4
Neutropenia, Grade 3 or 4
|
54 Participants
|
51 Participants
|
|
Number of Participants With Hematology Laboratory Results of Grade 3 or 4
Leukopenia, Grade 3 or 4
|
31 Participants
|
15 Participants
|
|
Number of Participants With Hematology Laboratory Results of Grade 3 or 4
Thrombocytopenia, Grade 3 or 4
|
14 Participants
|
1 Participants
|
|
Number of Participants With Hematology Laboratory Results of Grade 3 or 4
Anemia, Grade 3 or 4
|
15 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)Population: All participants who received any investigational product.
ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:\>ULN to 2.5\*ULN, Gr 2: \>2.5 to 5.0\*ULN, Gr 3: \>5.0 to 20.0\*ULN, Gr 4: \>20.0\*ULN; Aspartate aminotransferase (AST) Gr 1: \>ULN to 2.5\*ULN, Gr 2: \>2.5 to 5.0\*ULN, Gr 3: \>5.0 to 20.0\*ULN, Gr 4: \>20.0\*ULN
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=96 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=95 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results
ALP, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results
ALP. Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results
AST, Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results
AST, Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Randomization to death or last known alive date, up to 31.34 monthsPopulation: All participants randomized to receive treatment
Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.
Outcome measures
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
n=98 Participants
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=99 Participants
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors
βIII-tubulin positive subgroup (n=53, 51)
|
10.61 Months
95% Confidence Interval NA • Interval 7.16 to 13.96
|
11.37 Months
95% Confidence Interval NA • Interval 8.15 to 15.41
|
|
Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors
βIII-tubulin negative subgroup (n=45, 48)
|
16.92 Months
95% Confidence Interval NA • Interval 13.04 to 27.96
|
9.40 Months
95% Confidence Interval NA • Interval 7.98 to 13.4
|
|
Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors
Overall population
|
13.04 Months
95% Confidence Interval NA • Interval 9.99 to 14.52
|
10.15 Months
95% Confidence Interval NA • Interval 8.28 to 13.4
|
Adverse Events
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)
Serious events: 27 serious events
Other events: 88 other events
Deaths: 0 deaths
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
Serious events: 28 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)
n=95 participants at risk
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=96 participants at risk
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Investigations
BLOOD CREATININE INCREASED
|
1.1%
1/95
|
0.00%
0/96
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/95
|
1.0%
1/96
|
|
Cardiac disorders
CARDIAC ARREST
|
2.1%
2/95
|
0.00%
0/96
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.1%
1/95
|
0.00%
0/96
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/95
|
1.0%
1/96
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
1.1%
1/95
|
0.00%
0/96
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
1.1%
1/95
|
0.00%
0/96
|
|
Cardiac disorders
PERICARDITIS CONSTRICTIVE
|
1.1%
1/95
|
0.00%
0/96
|
|
Vascular disorders
PHLEBITIS
|
1.1%
1/95
|
0.00%
0/96
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/95
|
1.0%
1/96
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/95
|
1.0%
1/96
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.1%
1/95
|
0.00%
0/96
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
1.1%
1/95
|
0.00%
0/96
|
|
Nervous system disorders
SYNCOPE
|
2.1%
2/95
|
1.0%
1/96
|
|
Nervous system disorders
HEADACHE
|
1.1%
1/95
|
0.00%
0/96
|
|
Nervous system disorders
MYELITIS
|
0.00%
0/95
|
1.0%
1/96
|
|
Nervous system disorders
DIZZINESS
|
3.2%
3/95
|
0.00%
0/96
|
|
Nervous system disorders
CONVULSION
|
1.1%
1/95
|
1.0%
1/96
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/95
|
1.0%
1/96
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.00%
0/95
|
1.0%
1/96
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/95
|
1.0%
1/96
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/95
|
2.1%
2/96
|
|
Gastrointestinal disorders
NAUSEA
|
1.1%
1/95
|
0.00%
0/96
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.1%
1/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/95
|
1.0%
1/96
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
PNEUMONIA
|
3.2%
3/95
|
3.1%
3/96
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.1%
1/95
|
0.00%
0/96
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/95
|
1.0%
1/96
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.1%
1/95
|
1.0%
1/96
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/95
|
1.0%
1/96
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/95
|
1.0%
1/96
|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.2%
4/95
|
0.00%
0/96
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.1%
1/95
|
0.00%
0/96
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.1%
1/95
|
1.0%
1/96
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.1%
2/95
|
0.00%
0/96
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
2.1%
2/95
|
3.1%
3/96
|
|
Injury, poisoning and procedural complications
FRACTURE
|
1.1%
1/95
|
0.00%
0/96
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/95
|
1.0%
1/96
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
1.1%
1/95
|
0.00%
0/96
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.1%
1/95
|
2.1%
2/96
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
2.1%
2/95
|
0.00%
0/96
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HAEMORRHAGE
|
0.00%
0/95
|
1.0%
1/96
|
|
Respiratory, thoracic and mediastinal disorders
OESOPHAGOBRONCHIAL FISTULA
|
0.00%
0/95
|
1.0%
1/96
|
|
General disorders
PAIN
|
0.00%
0/95
|
1.0%
1/96
|
|
General disorders
FATIGUE
|
1.1%
1/95
|
1.0%
1/96
|
|
General disorders
PYREXIA
|
1.1%
1/95
|
2.1%
2/96
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/95
|
1.0%
1/96
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
1.1%
1/95
|
2.1%
2/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SARCOMA
|
0.00%
0/95
|
1.0%
1/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.00%
0/95
|
1.0%
1/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
1.1%
1/95
|
2.1%
2/96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
1.1%
1/95
|
1.0%
1/96
|
Other adverse events
| Measure |
Ixabepilone, 32 mg/m^2 + Carboplatin (AUC)
n=95 participants at risk
Ixabepilone administered as a 3-hour intravenous (IV) infusion at a starting dose of 32 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an area under the concentration-time curve (AUC) of 6 mg/mL per minute (AUC 6), on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
n=96 participants at risk
Paclitaxel administered as a 3-hour IV infusion at a starting dose of 200 mg/m\^2 on Day 1 of a 21-day cycle followed by carboplatin, administered at a dose calculated to produce an AUC 6, on Day 1 of a 21-day cycle for a maximum of 6 cycles
|
|---|---|---|
|
Psychiatric disorders
INSOMNIA
|
7.4%
7/95
|
7.3%
7/96
|
|
Immune system disorders
HYPERSENSITIVITY
|
2.1%
2/95
|
6.2%
6/96
|
|
Nervous system disorders
HEADACHE
|
5.3%
5/95
|
7.3%
7/96
|
|
Nervous system disorders
DIZZINESS
|
8.4%
8/95
|
7.3%
7/96
|
|
Nervous system disorders
DYSGEUSIA
|
4.2%
4/95
|
6.2%
6/96
|
|
Nervous system disorders
PARAESTHESIA
|
9.5%
9/95
|
9.4%
9/96
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
17.9%
17/95
|
22.9%
22/96
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
8.4%
8/95
|
21.9%
21/96
|
|
Gastrointestinal disorders
NAUSEA
|
43.2%
41/95
|
32.3%
31/96
|
|
Gastrointestinal disorders
VOMITING
|
17.9%
17/95
|
10.4%
10/96
|
|
Gastrointestinal disorders
DIARRHOEA
|
15.8%
15/95
|
16.7%
16/96
|
|
Gastrointestinal disorders
CONSTIPATION
|
12.6%
12/95
|
13.5%
13/96
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.1%
2/95
|
6.2%
6/96
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.3%
5/95
|
2.1%
2/96
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
31.6%
30/95
|
28.1%
27/96
|
|
Blood and lymphatic system disorders
ANAEMIA
|
26.3%
25/95
|
13.5%
13/96
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
12.6%
12/95
|
10.4%
10/96
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
33.7%
32/95
|
22.9%
22/96
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
17.9%
17/95
|
1.0%
1/96
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.3%
5/95
|
5.2%
5/96
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
47.4%
45/95
|
57.3%
55/96
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
4.2%
4/95
|
9.4%
9/96
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
15.8%
15/95
|
30.2%
29/96
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.3%
6/95
|
4.2%
4/96
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
15.8%
15/95
|
26.0%
25/96
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.2%
4/95
|
7.3%
7/96
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
9.5%
9/95
|
15.6%
15/96
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.4%
8/95
|
9.4%
9/96
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.3%
5/95
|
4.2%
4/96
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
11.6%
11/95
|
5.2%
5/96
|
|
General disorders
PAIN
|
6.3%
6/95
|
4.2%
4/96
|
|
General disorders
FATIGUE
|
33.7%
32/95
|
31.2%
30/96
|
|
General disorders
PYREXIA
|
10.5%
10/95
|
6.2%
6/96
|
|
General disorders
ASTHENIA
|
12.6%
12/95
|
17.7%
17/96
|
|
General disorders
CHEST PAIN
|
10.5%
10/95
|
14.6%
14/96
|
|
General disorders
OEDEMA PERIPHERAL
|
5.3%
5/95
|
5.2%
5/96
|
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