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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004909-34 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalation and Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within the first 21 days of first cycle |
| 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. | Within the first 21 days of first cycle |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Escalation Phase Subjects: Primary solid tumor not curable by local measures such as surgery, radiation
Inclusion Criteria:
Exclusion:
Expansion Phase Subjects: Advanced Non-small cell lung cancer
Inclusion Criteria:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| The Cancer Institute Of New Jersey |
A total of 30 participants were enrolled; 29 were treated (1 participant no longer met study criteria).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | Participants received both ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 and ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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. | all treated participants | Posted | Number | participants | Within the first 21 days of first cycle |
|
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Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixa 32 mg/m2 + Cis 60 mg/m2 | 6 participants with solid tumor (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) for 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BACTERAEMIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EAR PRURITUS | Ear and labyrinth disorders | MedDRA 13.1 | 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 |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
Not provided
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months |
|
| Ixabepilone | Drug | Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months |
|
|
| Cisplatin | Drug | Expansion: Solution, IV, 60-80 mg/m2, every 3 weeks, approximately 6 months |
|
| 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. |
| 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. | 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. |
| 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. | 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.) |
| 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. | 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. |
| 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 \ | 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. |
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Local Institution | Lucca | 55100 | Italy |
| Local Institution | Meldola (Fc) | 47014 | Italy |
| Local Institution | Rimini | 47900 | Italy |
| Local Institution | Viterbo | 01100 | Italy |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Karnofsky Performance Status | Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses. | Number | participants |
|
| OG001 | 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 |
|
|
| 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. | All treated participants | Posted | Number | participants | 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. |
|
|
|
| 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. | All subjects who received at least 1 dose of either ixabepilone or carboplatin | Posted | Number | mg/m^2 | Within the first 21 days of first cycle |
|
|
|
| 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. | This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued. | Posted | 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. |
|
|
| 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. | This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued. | Posted | 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.) |
|
|
| 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. | All treated participants | Posted | Number | participants | 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. |
|
|
|
| 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 \ | All treated participants | Posted | Number | participants | 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. |
|
|
|
| 7 |
| 24 |
| 24 |
| 24 |
| EG001 | Ixa 32 mg/m2 +Cis 80 mg/m2 | 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 | 2 | 5 | 5 | 5 |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| MUCOSAL INFLAMMATION | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| RESPIRATORY MONILIASIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| TYMPANOMETRY ABNORMAL | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| OEDEMA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| PRESYNCOPE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
|
| FLUSHING | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| NEUROTOXICITY | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| HERPES VIRUS INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| EAR CANAL ERYTHEMA | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 13.1 | 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.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Stable Disease |
|
| Disease Progression |
|
| Not Assessed |
|
| Drug-Related SAEs |
|
| AEs Leading to Discontinuation |
|
| Drug-Related AEs Leading to Discontinuation |
|
| Overall AEs |
|
| Grade 3/4 AEs |
|
| Drug-Related AEs |
|
| Grade 3/4 Drug-Related AEs |
|
| ANC, Grade 1-4 |
|
| ANC, Grade 3-4 |
|
| Platelet Count, Grade 1-4 |
|
| Platelet Count, Grade 3-4 |
|
| Hemoglobin, Grade 1-4 |
|
| Hemoglobin, Grade 3-4 |
|