Non Small Cell Lung Cancer
Conditions
Keywords
Lung Cancer (NSCLC)
Brief summary
The purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied
Interventions
DRUGIxabepilone
Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months
DRUGCisplatin
Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months
Sponsors
R-Pharm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Escalation Phase Subjects: Primary solid tumor not curable by local measures such as surgery, radiation Inclusion Criteria: * Men and women age ≥ 18 Exclusion: * More than 2 prior chemotherapy containing regimens for metastatic disease * No prior exposure to cisplatin or ixabepilone Expansion Phase Subjects: Advanced Non-small cell lung cancer Inclusion Criteria: * Men and women age ≥ 18 Exclusion: * No prior chemotherapy-containing regimen for metastatic disease * No prior exposure to cisplatin or ixabepilone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Experiencing Dose Limiting Toxicity (DLT) | Within the first 21 days of first cycle | DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for \>3 weeks;Gr4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever \>38.5°C;thrombocytopenia \<25,000 cells/mm\^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7. |
| Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2 | Within the first 21 days of first cycle | The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC) | The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.) | The duration of response will be computed for all treated subjects whose best response is either partial response (PR) or complete response (CR). The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. Subjects who neither relapse nor die will be censored on the date of their last tumor assessment. |
| Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm. | Complete Response(CR):Disappearance of all clinical/radiological evidence of target lesions (TL) & all nontarget lesions (NTL) + no new lesions (NWL). Partial Response(PR):CR of TL + persistence of \>=1 NTL (NonCR/NonPD) + no NWL; OR \>=30% decrease in sum of longest diameter(LD) of all TL + CR or NonCR/NonPD in NTL + no NWL. Progressive Disease (PD):\>=20% increase in sum of LD of TL regardless of NTL & NWL status; or unequivocal progression of NTL regardless of TL & NWL status; or NWL regardless of TL & NTL status. Stable Disease(SD): Neither PD nor PR in TL + CR or NonCR/NonPD in NTL + no NWL. |
| Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2. | Grade (Gr) 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Hemoglobin Gr1 \<LLN - 10.0 g/dL; Gr2 \<10.0 - 8.0 g/dL; Gr3 \<8.0 - 6.5 g/dL; Gr4 \<6.5 g/dL. White Blood Cell Count (WBC) Gr1 \<lower limit of normal (LLN) - 3000/mm\^3; Gr2 \<3000 - 2000/mm\^3; Gr3 \<2000 - 1000/mm\^3; Gr4 \<1000/mm\^3. Absolute Neutrophil Count (ANC) Gr 1 \<LLN - 1500/mm\^3; Gr 2 \<1500 - 1000/mm\^3; Gr3 \<1000 - 500/mm\^3; Gr 4 \<500/mm\^3. Platelets Gr1 \<LLN - 75,000/mm\^3; Gr2 \<75,000 - 50,000/mm\^3; Gr3 \<50,000 - 25,000/mm\^3; Gr4 \<25,000/mm\^3. Normal ranges vary by local laboratory. |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2. | AE=any new untoward medical occurrence/worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical event that results in death, persistent/significant incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires/prolongs inpatient hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. |
| Percentage of Participants With Response | At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm. | Response in participants with non-small cell lung cancer (NSCLC) was defined as the number of subjects in whose best response is partial response (PR) or complete response (CR) (see Outcome Measure 3 for definitions) divided by the total number of response evaluable subjects. |
Countries
Italy, United States
Participant flow
Pre-assignment details
A total of 30 participants were enrolled; 29 were treated (1 participant no longer met study criteria).
Participants by arm
| Arm | Count |
|---|---|
| Ixa 32 mg/m^2+Cis 60 mg/m^2 6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m\^2+ cisplatin (cis) 60 mg/m\^2 administered intravenously on Day 1 of a 21 day cycle | 24 |
| 32mg/m^2+Cis 80mg/m^2 5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m\^2+cis 80mg/m\^2, administered intravenously on Day 1 of a 21 day cycle | 5 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Disease Progression | 11 |
Baseline characteristics
| Characteristic | 32mg/m^2+Cis 80mg/m^2 | Total | Ixa 32 mg/m^2+Cis 60 mg/m^2 |
|---|---|---|---|
| Age, Continuous | 54 years | 63 years | 64 years |
| Age, Customized < 50 years | 2 participants | 5 participants | 3 participants |
| Age, Customized >= 50 years | 3 participants | 24 participants | 21 participants |
| Age, Customized < 65 years | 5 participants | 17 participants | 12 participants |
| Age, Customized >= 65 years | 0 participants | 12 participants | 12 participants |
| Karnofsky Performance Status 100 - Normal no complaints; no evidence of disease | 2 participants | 15 participants | 13 participants |
| Karnofsky Performance Status 80 - Activity with effort; some signs of disease | 2 participants | 11 participants | 9 participants |
| Karnofsky Performance Status 90 - Normal activity; minor signs of disease | 1 participants | 3 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 12 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 17 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 24 | 5 / 5 |
| serious Total, serious adverse events | 7 / 24 | 2 / 5 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2
The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level.
Time frame: Within the first 21 days of first cycle
Population: All subjects who received at least 1 dose of either ixabepilone or carboplatin
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2 | 60 mg/m^2 |
Primary
Participants Experiencing Dose Limiting Toxicity (DLT)
DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for \>3 weeks;Gr4 neutropenia (absolute neutrophil count \<500 cells/mm\^3) for \>=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever \>38.5°C;thrombocytopenia \<25,000 cells/mm\^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.
Time frame: Within the first 21 days of first cycle
Population: all treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Participants Experiencing Dose Limiting Toxicity (DLT) | 0 participants |
| 32mg/m^2+Cis 80mg/m^2 | Participants Experiencing Dose Limiting Toxicity (DLT) | 2 participants |
Secondary
Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC)
The duration of response will be computed for all treated subjects whose best response is either partial response (PR) or complete response (CR). The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. Subjects who neither relapse nor die will be censored on the date of their last tumor assessment.
Time frame: The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.)
Population: This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.
Secondary
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
AE=any new untoward medical occurrence/worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical event that results in death, persistent/significant incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires/prolongs inpatient hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening.
Time frame: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | SAEs | 7 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | AEs Leading to Discontinuation | 2 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Grade 3/4 Drug-Related AEs | 11 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Drug-Related AEs Leading to Discontinuation | 1 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Overall AEs | 24 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Death | 4 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Grade 3/4 AEs | 14 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Drug-Related SAEs | 4 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Drug-Related AEs | 24 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Drug-Related SAEs | 1 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | SAEs | 2 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Drug-Related AEs | 5 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Grade 3/4 Drug-Related AEs | 3 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Death | 1 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | AEs Leading to Discontinuation | 0 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Drug-Related AEs Leading to Discontinuation | 0 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Overall AEs | 5 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Grade 3/4 AEs | 3 participants |
Secondary
Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response(CR):Disappearance of all clinical/radiological evidence of target lesions (TL) & all nontarget lesions (NTL) + no new lesions (NWL). Partial Response(PR):CR of TL + persistence of \>=1 NTL (NonCR/NonPD) + no NWL; OR \>=30% decrease in sum of longest diameter(LD) of all TL + CR or NonCR/NonPD in NTL + no NWL. Progressive Disease (PD):\>=20% increase in sum of LD of TL regardless of NTL & NWL status; or unequivocal progression of NTL regardless of TL & NWL status; or NWL regardless of TL & NTL status. Stable Disease(SD): Neither PD nor PR in TL + CR or NonCR/NonPD in NTL + no NWL.
Time frame: At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Partial Response | 8 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Disease Progression | 5 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Stable Disease | 10 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Not Assessed | 1 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Complete Response | 0 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Not Assessed | 1 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Complete Response | 0 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Partial Response | 0 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Stable Disease | 2 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST) | Disease Progression | 2 participants |
Secondary
Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria
Grade (Gr) 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Hemoglobin Gr1 \<LLN - 10.0 g/dL; Gr2 \<10.0 - 8.0 g/dL; Gr3 \<8.0 - 6.5 g/dL; Gr4 \<6.5 g/dL. White Blood Cell Count (WBC) Gr1 \<lower limit of normal (LLN) - 3000/mm\^3; Gr2 \<3000 - 2000/mm\^3; Gr3 \<2000 - 1000/mm\^3; Gr4 \<1000/mm\^3. Absolute Neutrophil Count (ANC) Gr 1 \<LLN - 1500/mm\^3; Gr 2 \<1500 - 1000/mm\^3; Gr3 \<1000 - 500/mm\^3; Gr 4 \<500/mm\^3. Platelets Gr1 \<LLN - 75,000/mm\^3; Gr2 \<75,000 - 50,000/mm\^3; Gr3 \<50,000 - 25,000/mm\^3; Gr4 \<25,000/mm\^3. Normal ranges vary by local laboratory.
Time frame: Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | WBC, Grade 3-4 | 6 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | ANC, Grade 3-4 | 12 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Hemoglobin, Grade 3-4 | 1 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | WBC, Grade 1-4 | 19 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Platelet Count, Grade 3-4 | 0 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | ANC, Grade 1-4 | 18 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Hemoglobin, Grade 1-4 | 22 participants |
| Ixa 32 mg/m^2+Cis 60 mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Platelet Count, Grade 1-4 | 9 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Hemoglobin, Grade 3-4 | 0 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | WBC, Grade 3-4 | 3 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | ANC, Grade 1-4 | 5 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | ANC, Grade 3-4 | 4 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Platelet Count, Grade 1-4 | 3 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Hemoglobin, Grade 1-4 | 5 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | Platelet Count, Grade 3-4 | 1 participants |
| 32mg/m^2+Cis 80mg/m^2 | Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria | WBC, Grade 1-4 | 5 participants |
Secondary
Percentage of Participants With Response
Response in participants with non-small cell lung cancer (NSCLC) was defined as the number of subjects in whose best response is partial response (PR) or complete response (CR) (see Outcome Measure 3 for definitions) divided by the total number of response evaluable subjects.
Time frame: At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.
Population: This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.