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Terminated early when the results from Study NCT00300885 showed an overall lack of efficacy in NSCLC and increased mortality in subjects with squamous subtype.
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The purpose of this study conducted in Asia-Pacific was to evaluate the efficacy and safety of Sorafenib in combination with paclitaxel and carboplatin versus placebo in combination with paclitaxel and carboplatin for chemonaive patients with unresectable stage IIIB (with effusion) or stage IV NSCLC. However, as indicated below, the study was terminated prematurely when the results from Study 11961 (NCT00300885), an earlier Phase 3 study of similar design in subjects with advanced NSCLC, showed an overall lack of efficacy and increased mortality in subjects with squamous subtype. The data available is presented as descriptive analyses, due to the limitations of implementing the statistical analysis plan.
The study was terminated early when the results from Study 11961 (NCT00300885), an earlier Phase 3 study evaluating the effects of Sorafenib in combination with paclitaxel and carboplatin in subjects with advanced NSCLC, showed an overall lack of efficacy of Sorafenib in combination with paclitaxel and carboplatin in NSCLC and increased mortality in subjects with squamous subtype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib + Paclitaxel + Carboplatin | Experimental | Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. |
|
| Placebo + Paclitaxel + Carboplatin | Placebo Comparator | Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib + Paclitaxel + Carboplatin | Drug | Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression free survival (PFS) is the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented. Since the study was terminated early and 89% of subjects' data were censored, only the number of PFS events (Failed [progressed or died before progression]) is reported, not the usual measure "number of days". | Up to 5 months after randomization of the first patient |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is the number of days from the date of randomization to the date of death due to any cause. Subjects alive at the time of analysis were censored at their last date of follow-up. Since the study was terminated early and 89% of subjects' data were censored, only the number of subjects who Failed (died) or were Censored is reported, not the usual measure "number of days". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | 510060 | China | |||
At the time of study termination, 91 (out of 108 screened subjects) of the planned 294 subjects had been screened and randomized. All 91 randomized subjects received at least 1 dose of study drug and were included in both the intent-to-treat (ITT) and safety analysis populations.
Subjects were recruited from 23 Sep 2007 to 12 May 2008 (first subject's first visit to last subject's last visit) at 15 centers in 4 countries: China (9), Singapore (2), Thailand (2), and Taiwan (2). The study was terminated prematurely after about 5 months of recruitment and before the planned 230 progression free survival (PFS) events occurred.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib + Paclitaxel + Carboplatin | Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
Not provided
Not provided
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Not provided
|
| Placebo + Paclitaxel + Carboplatin | Drug | Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days |
|
| Up to 5 months after randomization of the first patient |
| Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST) | Complete response (CR): Disappearance of all target lesions (TL). Partial response (PR): At least 30% decrease in sum of the largest diameter (LD) of TLs, taking baseline sum as reference. Stable disease (SD): No change in tumor size. Progressive disease (PD): At least a 20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since treatment started, or the appearance of 1 or more new lesions. | Best tumor response assessed every 6 weeks by investigator during treatment up to 5 months after randomization of the first patient. |
| Duration of Response | Duration of response (PR or better) was defined as the time from the first documented objective PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Since only 4 subjects had a response, the duration of response was not calculated. | Time from first documented objective response (complete response or partial response) to disease progression or death, or to last tumor assessment if censored, up to 5 months after randomization of the first patient. |
| Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2 | The LCS is a validated instrument for determining treatment impact on lung symptoms. The LCS consists of 7 questions with 5 responses ranging from "not at all" to "very much". The LCS total score ranges from 0 to 28. Lower scores reflect greater lung cancer symptoms. | Change from baseline of LCS score assessed at each treatment cycle starting with Cycle 2 (Cycles 2, 3, 4, 5, 6, 7; 21 days per cycle) up to 5 months after randomization of the first patient. |
| Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 3 and Cycle 5 | HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL. | Change from baseline of HRQoL score assessed (at treatment Cycle 3 and Cycles 5 [21 days per cycle]) up to 5 months after randomization of the first patient. |
| Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 7 | HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL. | Change from baseline of HRQoL score assessed (at treatment Cycle 7 [21 days per cycle]) up to 5 months after randomization of the first patient. |
| Guangzhou |
| Guangdong |
| 510515 |
| China |
| Shatin | Hong Kong | China |
| Nanjing | Jiangsu | 210003 | China |
| Hangzhou | Zhejiang | (310022), | China |
| Hangzhou | Zhejiang | 310016 | China |
| Beijing | 100021 | China |
| Beijing | 100142 | China |
| Beijing | 100730 | China |
| Chongqing | 400038 | China |
| Shanghai | 200032 | China |
| Shanghai | 200433 | China |
| Mumbai | Maharashtra | 400012 | India |
| New Delhi | 110008 | India |
| Singapore | 119228 | Singapore |
| Singapore | 169610 | Singapore |
| Gyeonggi-do | 410-769 | South Korea |
| Seoul | 136-705 | South Korea |
| Taipei | Taiwan | 100 | Taiwan |
| Changhua | 500 | Taiwan |
| Bangkok | Bangkok | 10330 | Thailand |
| Bangkok | Bangkok | Thailand |
| FG001 | Placebo + Paclitaxel + Carboplatin | Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days |
| Start of Maintenance Monotherapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib + Paclitaxel + Carboplatin | Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. |
| BG001 | Placebo + Paclitaxel + Carboplatin | Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) performance status | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study must have had an ECOG score of 0 or 1(restricted in physically strenuous activity but ambulatory). | Number | Participants |
| |||||||||||||||||
| Geographic region | Subjects in the study were stratified as to whether they were from China or not from China. | Number | Participants |
| |||||||||||||||||
| Histology | Subjects in the study were stratified by the histology of their non-small cell lung cancer into non-squamous vs squamous. | Number | Participants |
| |||||||||||||||||
| Stage at study entry | Subjects in the study were stratified by the stage of their disease: Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion) or Stage IV histological or cytological confirmation of Non-Small Cell Lung Cancer (NSCLC). | Number | 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 | Progression Free Survival | Progression free survival (PFS) is the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before progression was documented. Since the study was terminated early and 89% of subjects' data were censored, only the number of PFS events (Failed [progressed or died before progression]) is reported, not the usual measure "number of days". | It was intended to include all randomized subjects (the intent to treat (ITT) population) in the analysis. Since 89% of subjects were censored, PFS could not be calculated. The number of subjects who Failed (progressed or died before progression) or were Censored are reported. | Posted | Number | Participants | Up to 5 months after randomization of the first patient |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival is the number of days from the date of randomization to the date of death due to any cause. Subjects alive at the time of analysis were censored at their last date of follow-up. Since the study was terminated early and 89% of subjects' data were censored, only the number of subjects who Failed (died) or were Censored is reported, not the usual measure "number of days". | All randomized subjects (the intent to treat (ITT) population) were included in the analysis. Since 89% of subjects were censored, OS could not be calculated. The number of subjects who Failed (died) or were Censored are reported. | Posted | Number | Participants | Up to 5 months after randomization of the first patient |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Best Tumor Response (Number of Responses Per Category) According to Response Evaluation Criteria in Solid Tumors (RECIST) | Complete response (CR): Disappearance of all target lesions (TL). Partial response (PR): At least 30% decrease in sum of the largest diameter (LD) of TLs, taking baseline sum as reference. Stable disease (SD): No change in tumor size. Progressive disease (PD): At least a 20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since treatment started, or the appearance of 1 or more new lesions. | All randomized subjects (the intent to treat (ITT) population) were included in the analysis. | Posted | Number | Participants | Best tumor response assessed every 6 weeks by investigator during treatment up to 5 months after randomization of the first patient. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response (PR or better) was defined as the time from the first documented objective PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Since only 4 subjects had a response, the duration of response was not calculated. | All subjects that showed a response. Since only 4 subjects had a response, the data were not analyzed. | Posted | Number | days | Time from first documented objective response (complete response or partial response) to disease progression or death, or to last tumor assessment if censored, up to 5 months after randomization of the first patient. |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of Lung Cancer Symptoms (LCS) Score Assessed at Each Treatment Cycle (21 Days Per Cycle) Starting With Cycle 2 | The LCS is a validated instrument for determining treatment impact on lung symptoms. The LCS consists of 7 questions with 5 responses ranging from "not at all" to "very much". The LCS total score ranges from 0 to 28. Lower scores reflect greater lung cancer symptoms. | Of the 91 randomized subjects in the ITT population, 90 completed the LCS at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the response rate (number of evaluable subjects completing the questionnaire) decreased from cycle to cycle and makes the results hard to interpret. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline of LCS score assessed at each treatment cycle starting with Cycle 2 (Cycles 2, 3, 4, 5, 6, 7; 21 days per cycle) up to 5 months after randomization of the first patient. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 3 and Cycle 5 | HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL. | Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline of HRQoL score assessed (at treatment Cycle 3 and Cycles 5 [21 days per cycle]) up to 5 months after randomization of the first patient. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of Health-Related Quality of Life (HRQoL) Score Assessed at Treatment Cycle 7 | HRQoL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores demonstrate impaired HRQoL. | Of the 91 randomized subjects in the ITT population, 88 completed the FACT-L at baseline. Since more than half of the subjects received only 1 or 2 cycles before the trial was stopped, the number of subjects who completed the questionnaire after the first cycles was very low, making the results difficult to interpret. | Posted | Mean | Standard Deviation | Units on a scale | Change from baseline of HRQoL score assessed (at treatment Cycle 7 [21 days per cycle]) up to 5 months after randomization of the first patient. |
|
Not provided
The following acronyms and abbreviations were used in the Results section: Absolute Neutrophil Count (ANC); Not Otherwise Specified (NOS); Alanine aminotransferase (ALT); Gastrointestinal (GI)
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 | Sorafenib + Paclitaxel + Carboplatin | Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days. | 11 | 47 | 45 | 47 | ||
| EG001 | Placebo + Paclitaxel + Carboplatin | Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days | 3 | 44 | 39 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Neutrophiles | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Rash/Desquamation | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Infection (documented clinically), Lung (Pneumonia) | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, blood | Infections and infestations | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Pain, abdomen NOS | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Thrombosis/Embolism (vascular access) | Vascular disorders | NCI CTC 3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Rash/Desquamation | Skin and subcutaneous tissue disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | NCI CTC 3.0 | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Supraventricular arrhythmia, sinus tachycardia | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Insomnia | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, bone | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, extremity-limb | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, joint | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, muscle | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
Due to early termination of the study, no comparison of treatments was possible. This study also provided limited opportunity to distinguish between Adverse Events associated with sorafenib and events associated with the underlying lung disease.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Grade 1: Restricted strenuous activity, ambulatory |
|
| Non-China |
|
| Other |
|
| Missing histology |
|
| Stage IIIB |
|
| Stage IV |
|
|
|
|
|
|
|
|
|
Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
|
|
Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
|
|