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The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL | Active Comparator |
| |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL | Drug | On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose-limiting Toxicity (DLT) | DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. | Days 1 through 21 (Cycle 1) |
| Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 | The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles. | Days 1 through 21 (Cycle 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Chuo-Ku | Tokyo | 104-0045 | Japan |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Level 1 |
|
| |||||||||||||||||||||
| Dose Level 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/Min/mL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicity (DLT) | DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. | All participants who received at least 1 dose of either ixabepilone or carboplatin | Posted | Number | Participants | Days 1 through 21 (Cycle 1) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SUPERIOR VENA CAVAL OCCLUSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenopia | Eye disorders | MedDRA 12.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C430592 | ixabepilone |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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|
|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL | Drug | After all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles. |
|
| Days 1 through 21 (Cycle 1) |
| Number of Participants With Grade 3 or Greater Treatment-related AEs | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug. | Days 1 through 21 (Cycle 1) |
| Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365) Appendix 7.1.2 | At screening and Days 8 and 15 of Cycle 1 (21 days) |
| Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L) | At screening and Days 8 and 15 of Cycle 1 (21 days) |
| Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry. | At screening and Days 8 and 15 of Cycle 1 (21 days) |
| Number of Participants With Abnormalities in Blood Pressure and Heart Rate | Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE. | At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) |
| Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair. | At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) |
| Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met. | Days 1 through 21 (Cycle 1) |
| Maximum Observed Plasma Concentration of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) |
| Time of Maximum Observed Plasma Concentration of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) |
| Volume of Distribution at Steady State of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) |
| Total Body Clearance of Ixabepilone | Days 1 to 8 of Cycle 1 (21 days) |
| NOT COMPLETED |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG001 | 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. |
|
|
| Primary | Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2 | The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles. | All participants who received at least 1 dose of either ixabepilone or carboplatin | Posted | Number | mg/min/mL | Days 1 through 21 (Cycle 1) |
|
|
|
| Secondary | Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation | An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug. | All participants who received at least 1 dose of either ixabepilone or carboplatin | Posted | Number | Participants | Days 1 through 21 (Cycle 1) |
|
|
|
| Secondary | Number of Participants With Grade 3 or Greater Treatment-related AEs | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug. | All subjects who received at least 1 dose of either ixabepilone or carboplatin | Posted | Number | Participants | Days 1 through 21 (Cycle 1) |
|
|
|
| Secondary | Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade | LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365) Appendix 7.1.2 | All participants who received at least 1 dose of either ixabepilone or carboplatin | Posted | Number | Participants | At screening and Days 8 and 15 of Cycle 1 (21 days) |
|
|
|
| Secondary | Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade | ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L) | All participants who received at least 1 dose of either ixabepilone or carboplatin | Posted | Number | Participants | At screening and Days 8 and 15 of Cycle 1 (21 days) |
|
|
|
| Secondary | Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade | Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry. | Posted | Number | Participants | At screening and Days 8 and 15 of Cycle 1 (21 days) |
|
|
|
| Secondary | Number of Participants With Abnormalities in Blood Pressure and Heart Rate | Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE. | Posted | Number | Participants | At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) |
|
|
|
| Secondary | Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status | Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair. | Posted | Number | Participants | At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22) |
|
|
|
| Secondary | Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment | Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met. | All treated participants with measurable disease at baseline, as determined by investigator | Posted | Number | Participants | Days 1 through 21 (Cycle 1) |
|
|
|
| Secondary | Maximum Observed Plasma Concentration of Ixabepilone | All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles | Posted | Geometric Mean | Standard Deviation | ng/mL | Days 1 to 8 of Cycle 1 (21 days) |
|
|
|
| Secondary | Time of Maximum Observed Plasma Concentration of Ixabepilone | All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles | Posted | Mean | Standard Deviation | Hours | Days 1 to 8 of Cycle 1 (21 days) |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone | All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles | Posted | Geometric Mean | Standard Deviation | ng*h/mL | Days 1 to 8 of Cycle 1 (21 days) |
|
|
|
| Secondary | Volume of Distribution at Steady State of Ixabepilone | All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles | Posted | Mean | Standard Deviation | Liters | Days 1 to 8 of Cycle 1 (21 days) |
|
|
|
| Secondary | Total Body Clearance of Ixabepilone | All participants who received ixabepilone and carboplatin and had adequate pharmacokinetic concentration profiles | Posted | Mean | Standard Deviation | Liters/hour | Days 1 to 8 of Cycle 1 (21 days) |
|
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Ixabepilone, 32 mg/m2 + 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. | 0 | 6 | 6 | 6 |
| Protein urine | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Superior vena caval occlusion | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Glycosuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| SAEs |
|
| AEs |
|
| Treatment-related AEs leading to discontinuation |
|
| Anemia |
|
| Thrombocytopenia |
|
| Lymphopenia |
|
| Nausea |
|
| Liver function test abnormality |
|
| Deep vein thrombosis |
|
| Hemoglobin: Grade 3 (6.5-<8.0) |
|
| Hemoglobin: Grade 4 (<6.5) |
|
| Hemoglobin: Not reported |
|
| Leukocytes: Grade 1 (3.0-<LLN) |
|
| Leukocytes: Grade 2 (2.0-<3.0) |
|
| Leukocytes: Grade 3 (1.0-<2.0) |
|
| Leukocytes: Grade 4 (<1.0) |
|
| Leukocytes: Not reported |
|
| Lymphocytes (absolute): Grade 1 (0.8-<1.5) |
|
| Lymphocytes (absolute): Grade 2 (0.5-<0.8) |
|
| Lymphocytes (absolute): Grade 3 (0.2-<0.5) |
|
| Lymphocytes (absolute): Grade 4 (<0.2) |
|
| Lymphocytes: Not reported |
|
| Neutrophils (absolute): Grade 1 (1.5-<2.0) |
|
| Neutrophils (absolute): Grade 2 (1.0-<1.5) |
|
| Neutrophils (absolute): Grade 3 (0.5-<1.0) |
|
| Neutrophils (absolute): Grade 4 (<0.5) |
|
| Neutrophils (absolute): Not reported |
|
| Neutrophils+bands (absolute): Grade 1 (1.5-<2.0) |
|
| Neutrophils+bands (absolute): Grade 2 (1.0-<1.5) |
|
| Neutrophils+bands (absolute): Grade 3 (0.5-<1.0) |
|
| Neutrophils+bands (absolute): Grade 4 (<0.5) |
|
| Neutrophils+bands (absolute): Not reported |
|
| Platelet count: Grade 1 (75.0-<LLN) |
|
| Platelet count: Grade 2 (50.0-<75.0) |
|
| Platelet count: Grade 3 (25.0-<50.0) |
|
| Platelet count: Grade 4 (<25.0) |
|
| Platelet count: Not reported |
|
| ALT: Grade 3 ( >5.0-20.0*ULN ) |
|
| Albumin: Grade 1 (<LLN-3.0) |
|
| ALP: Grade 1 ( >1.0-2.5*ULN) |
|
| AST: Grade 1 ( >1.0-2.5*ULN) |
|
| AST: Grade 2 (>2.5-5.0*ULN) |
|
| Bilirubin: Grade 1 (>1.0-1.5*ULN) |
|
| Bilirubin: Grade 2 (>1.5-3.0*ULN) |
|
| Calcium: Grade 1 (8.0-<LLN or >ULN -11.5) |
|
| Creatinine: Grade 1 (>1.0-1.5*ULN) |
|
| Potassium: Grade 1 (3.0-<LLN or >ULN-5.5) |
|
| Sodium: Grade 1 (130-<LLN or >ULN-150) |
|
| Protein (Grade 3) |
|
| Protein (Grade 4) |
|
| Not reported |
|
| Weight |
|
| ECOG performance status |
|
| PD |
|
| SD |
|
| Unable to be assessed (patient discontinuation) |
|