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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Experimental | Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. |
|
| Placebo + Dacarbazine | Active Comparator | Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day. | Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date. | Time from randomization to death (the maximum treatment duration of 71.1 weeks) |
| Number of Participants in Tumor Response Categories |
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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 |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18445842 | Result | McDermott DF, Sosman JA, Gonzalez R, Hodi FS, Linette GP, Richards J, Jakub JW, Beeram M, Tarantolo S, Agarwala S, Frenette G, Puzanov I, Cranmer L, Lewis K, Kirkwood J, White JM, Xia C, Patel K, Hersh E. Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. J Clin Oncol. 2008 May 1;26(13):2178-85. doi: 10.1200/JCO.2007.14.8288. |
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A total of 101 subjects were randomized (50 to Placebo + Dacarbazine (DTIC) and 51 to Sorafenib + DTIC) and were included in the population valid for intent to treat (ITT) analyses. All randomized subjects received study drug and were included in the population valid for safety analyses.
A total of 121 subjects were enrolled at 17 centers in the United States. There were 20 screening failures; 12 subjects did not meet 1 or more entry criteria, 4 subjects withdrew consent before randomization, and 4 subjects were not randomized for other reasons. 101 subjects were randomized between 21 Mar 2005 and 27 Apr 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind (DB) Treatment |
|
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| Placebo | Drug | Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21 |
|
| Dacarbazine | Drug | Dacarbazine, 1000 mg/m^2 intravenous on Study Day 1 |
|
Tumor response was defined as the best response (confirmed complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]) assessed using the Response Evaluation Criteria in Solid Tumors (RECIST). PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD. CR: Disappearance of all target lesions. SD: Does not qualify for CR or PR. PD: at least a 20% increase in SLD taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. |
| Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| Time to Progression (TTP) | TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day. | Time from randomization to documented tumor progression (median time of 148 days) |
| Duration of Response (DOR) | Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. | Time from initial response to documented tumor progression or death (median time of 188 days) |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started). | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted | European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ-5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health. | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment | European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ-5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health. | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted | European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100. | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment | European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100. | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Lakeland | Florida | 33805 | United States |
| Park Ridge | Illinois | 60068 | United States |
| Boston | Massachusetts | 02114 | United States |
| Boston | Massachusetts | 02115-6084 | United States |
| Boston | Massachusetts | 02215 | United States |
| St Louis | Missouri | 63110-1093 | United States |
| Omaha | Nebraska | 68114 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| Hilton Head Island | South Carolina | 29926-2739 | United States |
| Nashville | Tennessee | 37232-6307 | United States |
| San Antonio | Texas | 78229 | United States |
| FG001 | Placebo + Dacarbazine | Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Active Follow-up |
|
|
| Long Term Follow-up |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. |
| BG001 | Placebo + Dacarbazine | Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| American Joint Committee on Cancer (AJCC) Stage at Study Entry | Stage III: Clinical or radiological evidence of regional metastases (M), in either the lymph nodes or intra-lymphatic. Stage IV: M at any distant site. M1a: M to the skin, subcutaneous tissue, or lymph nodes. M1b: M to the lung. M1c: M to all other visceral sites or at any site associated with an elevated serum lactate dehydrogenase. | Number | participants |
| |||||||||||||||
| Baseline 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 |
| |||||||||||||||
| Lactate dehydrogenase (LDH) at study entry | Lactate dehydrogenase (LDH) was assessed at study entry as part of a battery of tests to assess liver function. A typical normal range is 105 to 333 Units/Liter (U/L), but may vary across laboratories. | 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 (PFS) | PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors [RECIST] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. PFS for subjects who had no tumor assessments after baseline and did not die was censored at 1 day. | PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Median | 95% Confidence Interval | days | Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks) |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall Survival (OS) was calculated as the number of days from date of randomization to death date. Subjects who had not died at the time of analysis were censored at their last contact date. | OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Median | 95% Confidence Interval | days | Time from randomization to death (the maximum treatment duration of 71.1 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants in Tumor Response Categories | Tumor response was defined as the best response (confirmed complete response [CR], partial response [PR], stable disease [SD], or progressive disease [PD]) assessed using the Response Evaluation Criteria in Solid Tumors (RECIST). PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD. CR: Disappearance of all target lesions. SD: Does not qualify for CR or PR. PD: at least a 20% increase in SLD taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. | Tumor response was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Number | participants | Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (per modified RECIST or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease). The actual dates of tumor assessments were used for this calculation. TTP for subjects without disease progression at the time of analysis, including subjects with death prior to progression, was censored at the last date of tumor evaluation. TTP for subjects who had no tumor assessments after baseline was censored at 1 day. | TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Median | 95% Confidence Interval | days | Time from randomization to documented tumor progression (median time of 148 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of response was defined as the time from the first documented objective response of Partial Response (PR: At least a 30% decrease in the sum of the longest diameter [SLD] of target lesions, taking as reference the baseline SLD or better) or Complete Response (CR: Disappearance of all target lesions), whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. | DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Median | 95% Confidence Interval | days | Time from initial response to documented tumor progression or death (median time of 188 days) |
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| Secondary | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | Change in ECOG PS is defined as an improvement (increase) or worsening (decrease) of at least one grade from the baseline ECOG score (from 0 [fully active] to 5 [dead]). Change in ECOG PS was recorded at the visit at which best confirmed response (BCR) using the modified RECIST (PR, CR, stable disease or Progressive Disease (PD)) was first noted (the change was 7% for both Sorafenib and Placebo). The BCR is the BCR recorded from the start of the treatment until DP/recurrence (taking as reference for DP, the smallest measurements recorded since treatment started). | Change in ECOG performance status was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Number | participants | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted | European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ-5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health. | Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment | European Quality of Life 5-dimensional (EQ-5D) is a self-administered questionnaire developed to measure health status across 5 dimensions: Mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). The five dimensions are summarized into a single score, the EQ-5D index score, which ranges between 0 and 1, with 0 representing the worst imaginable health state or death and 1 representing perfect health. | Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted | European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100. | Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment | European Quality of Life Visual Analogue Scale (EQ-VAS) is a self-administered test that records the respondents' self-rated health status on a visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Responders specify their scales by indicating a position along a continuous line between 0 and 100. | Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days |
|
Not provided
Abbreviations used in the Adverse Events section: Absolute Neutrophil Count (ANC), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Central Nervous System (CNS), Common Terminology Criteria for Adverse Events (CTCAE), Gastro-Intestinal (GI), National Cancer Institute (NCI), Not Otherwise Specified (NOS)
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) + Dacarbazine | Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. | 22 | 51 | 49 | 51 | ||
| EG001 | Placebo + Dacarbazine | Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. | 14 | 50 | 45 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| platelets | 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 |
| |
| hemoglobin | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| leukocytes | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| supraventricular arrhythmia, atrial fibrillation | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| supraventricular arrhythmia, supraventricular tachycardia | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| hypotension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| cardiac ischemia / infarction | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| cardiopulmonary arrest | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| hypertension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| death not associated with CTCAE term, disease progression NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| death not associated with CTCAE term, multi-organ failure | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| fever | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| constitutional symptoms - other | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| rigors / chills | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ascites | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| constipation | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| dehydration | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CNS hemorrhage | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| hemorrhage, GI, abdomen NOS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| hemorrhage, GI, upper GI NOS | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| hemorrhage - other | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| hemorrhage pulmonary, nose | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| cholecystitis | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| liver dysfunction | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| pancreatitis | Hepatobiliary disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| infection - other | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| infection with unknown ANC, skin (cellulitis) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| fracture | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| CNS ischemia | 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 |
| |
| psychosis | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| seizure | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| blurred vision | Eye disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| pain, chest / thorax NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| pain, abdomen NOS | 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, muscle | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| pain, pain NOS | General 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 |
| |
| renal failure | 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 |
| |
| thrombosis / thrombus / embolism | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| no code in CTCAE | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic reaction | Immune system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| platelets | 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 |
| |
| hemoglobin | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| leukocytes | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| lymphopenia | 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 |
| |
| fatigue | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| weight loss | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| rigors / chills | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| sweating | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| fever | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| anorexia | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| constipation | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| heartburn | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| GI - other | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| flatulence | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| taste alteration | 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 |
| |
| dry mouth | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| edema: limb | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| lipase | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALT | 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 |
| |
| AST | 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 |
| |
| hypophosphatemia | 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 |
| |
| hypomagnesemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| neuropathy: sensory | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| dizziness | Nervous system 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, extremity - limb | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| pain, pain NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| pain, other | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| voice changes | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| rash / desquamation | 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 |
| |
| hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| alopecia | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| injection site reaction | 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 |
| |
| flushing | 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 |
| |
| acne | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D003606 | Dacarbazine |
| 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 |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
Not provided
Not provided
| >=65 and <75 years |
|
| >=75 years |
|
| Male |
|
| Stage IV M1a |
|
| Stage IV M1b |
|
| Stage IV M1c |
|
| Status 1 |
|
| Low |
|
| High |
|
| Missing |
|
|
|
|
|
|
|
|
|
|
|
|
Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. |
|
|
Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. |
|
|
|
Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
|
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