Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004875-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.
This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.
Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events section.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomiting); Day 1-28 400 mg bid, Day 29-56 600 mg bid, Day 57 onwards 800 mg bid. Subjects will continue on treatment until progression, unacceptable toxicity, subject withdraws consent or the decision is taken to stop the study following the analysis of response rates. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response - mITT (Modified Intent-to-treat) Population | Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes. | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
| Tumor Response - ITT (Intent to Treat) Population | Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions. | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response - mITT Population | Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux | 33000 | France | ||||
Not provided
| Label | URL |
|---|---|
| Click here and search for Bayer product information provided by EMA | View source |
Not provided
Of the 89 subjects enrolled, 83 were treated with the study drug. Safety population = 83 subjects who took at least one dose of study drug and had any data after baseline. Intent to treat population = 67 subjects treated with the study drug who had at least one efficacy evaluation after baseline.
Subjects were enrolled from 04 Feb to 05 Nov 2008 at 19 centers in 5 countries (Germany, France, United Kingdom, Italy and Poland).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) | Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss) | AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. |
| Pharmacokinetics (PK) Analysis - Maximum Observed Concentration in Plasma (Cmax) | Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. |
| Pharmacokinetics (PK) Analysis - Time to Maximum Concentration (Tmax) | Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. |
| Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan. | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
| Time to Progression (TTP) | Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan. | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
| Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
| Disease Control - mITT Population | Disease Control (DC) of a subject was defined as the proportion of patients with confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, and SD was defined as steady state of disease. | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
| La Roche-sur-Yon |
| 85925 |
| France |
| Marseille | 13385 | France |
| Nantes | 44805 | France |
| Paris | 75475 | France |
| Tours | 37044 | France |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Marburg | Hesse | 35043 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Jena | Thuringia | 07740 | Germany |
| Aviano | Pordenone | 33081 | Italy |
| Milan | 20133 | Italy |
| Pavia | 27100 | Italy |
| Olsztyn | 10-226 | Poland |
| Warsaw | 02-781 | Poland |
| Warsaw | 04-141 | Poland |
| Wroclaw | 50 - 556 | Poland |
| London | London | SW3 6JJ | United Kingdom |
| Greater Manchester | Manchester | M20 4BX | United Kingdom |
| Cardiff | South Glamorgan | CF14 7TB | United Kingdom |
| Glasgow | G12 0YN | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) | Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| ECOG (Eastern Cooperative Oncology Group) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). Status 0 = fully active; Status 1 = restricted strenuous activity, ambulatory and able to carry out work of a light or sedentary nature | Number | participants |
| ||||||||||||||||||||||
| Stage at study entry | Categorized information on tumor size, lymph node involvement and metastases. Stages I-IV. The higher the stage, the more advanced cancer. | 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 | Best Response - mITT (Modified Intent-to-treat) Population | Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes. | The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose. | Posted | Number | Participants | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
|
|
| ||||||||||||||||||||||||||
| Primary | Tumor Response - ITT (Intent to Treat) Population | Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions. | The population for the efficacy analysis was the intent-to-treat (ITT) population defined as all patients who received at least one dose of study medication with at least one valid tumor assessment post-baseline. | Posted | Number | participants | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss) | AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. | PK Analysis Population. 40 participants in the 400 mg bid group that had an AUC(0-10)ss calculated; 30 participants in the 600 mg bid group that had an AUC(0-10)ss calculated; 26 participants and 27 participants in the 800 mg bid group that had an AUC(0-10)ss calculated, for sorafenib and M2 parameter respectively. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg*h/L | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose. |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss) | AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. | PK Analysis Population. 32 participants in the 400 mg bid group that had an AUC(0-12)ss calculated; 23 participants in the 600 mg bid group that had an AUC(0-12)ss calculated; 19 participants and 20 participants in the 800 mg bid group that had an AUC(0-12)ss calculated, for sorafenib and M2 parameter respectively. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg*h/L | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Analysis - Maximum Observed Concentration in Plasma (Cmax) | Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. | PK Analysis Population. 40 participants in the 400 mg bid group that had Cmax calculated; 31 participants in the 600 mg bid group that had Cmax calculated; 28 participants in the 800 mg bid group that had Cmax calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. |
| |||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Analysis - Time to Maximum Concentration (Tmax) | Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib. | PK Analysis Population. 40 participants in the 400 mg bid group that had Tmax calculated; 31 participants in the 600 mg bid group that had Tmax calculated; 28 participants in the 800 mg bid group that had Tmax calculated. | Posted | Median | Full Range | hours | Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose. |
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan. | Intent-to-treat (ITT). | Posted | Median | 95% Confidence Interval | months | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan. | Intent-to treat (ITT). | Posted | Median | 95% Confidence Interval | months | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Tumor Response - mITT Population | Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions. | The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose. | Posted | Number | Participants | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Disease Control - mITT Population | Disease Control (DC) of a subject was defined as the proportion of patients with confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, and SD was defined as steady state of disease. | The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose. | Posted | Number | Participants | Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months. |
|
|
Not provided
Abbreviations used in the Adverse Events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma glutamyl transpeptidase (GGT)
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 (Nexavar, BAY43-9006) | Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle,600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed. | 45 | 83 | 80 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Cardiac arrhythmia - Other | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Cardiac general - Other | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GI - Other | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Constitutional symptoms - Other | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Abdomen NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Back | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Bone | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Breast | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Chest/Thorax NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Joint | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Other | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Stomach | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hepatobiliary - Other | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (Documented clinically), Kidney | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (Documented clinically), Lung (Pneumonia) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Abdomen NOS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Anal/perianal | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection with normal ANC, Sinus | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Intraop injury - Other | Injury, poisoning and procedural complications | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypercalcemia | 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 |
| |
| Hyperkalemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypocalcemia | 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 |
| |
| Fracture | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Musculoskeletal - Other | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Secondary malignancy (possibly related to cancer treatment) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neurology - Other | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Airway obstruction, Bronchus | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dermatology - Other | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema: Limb | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Ocular - Other | Eye disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GI - Other | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mucositis (clinical exam), Oral cavity | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), Oral cavity | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Taste Alteration | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Constitutional symptoms - Other | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Flu-like syndrome | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Insomnia | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Abdomen NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Back | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Bone | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Breast | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Chest wall | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Chest/Thorax NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Dental/Teeth/peridontal | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Extremity - limb | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Head/Headache | 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 |
| |
| Pain, Other | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, Stomach | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Weight loss | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Allergy - Other | Immune system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (Documented clinically), Bladder (urinary) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (Documented clinically), Skin (Cellulitis) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (Documented clinically), Urinary tract NOS | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection - Other | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| AST | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GGT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyperkalemia | 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 |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypocalcemia | 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 |
| |
| 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 |
| |
| Metabolic/Lab - Other | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Musculoskeletal - Other | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mood Alteration, Anxiety | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mood alteration, Depression | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neurology - Other | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Renal - Other | Renal and urinary 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 |
| |
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Voice changes | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dermatology - Other | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage pulmonary, Nose | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, Oral cavity | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
The Principal Investigator (PI) can publish results following completion of study. The PI must discuss a publication with Bayer prior to release&obtain written consent to proceed. The Investigator must send a draft to Bayer at least 30d in advance of submission to obtain approval. Any submission to Bayer will be reviewed w/o unreasonable delay&approval not be withheld unreasonably. In difference of opinion publication will be discussed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| 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 |
Not provided
Not provided
| Counts |
|---|
| Participants |
|
|
Participants received 800 mg orally twice daily (bid)
|
|
Participants received 800 mg orally twice daily (bid)
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|