Cancer, Melanoma
Conditions
Brief summary
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.
Interventions
DRUGSorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
DRUGPlacebo
Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21
DRUGDacarbazine
Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1
Sponsors
Amgen
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have a life expectancy of at least 12 weeks * Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma * Patients who have an ECOG PS of 0, or 1 * Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
Exclusion criteria
* Primary ocular or mucosal melanoma * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: flat tumor\] & T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 3 years prior to study entry * History of cardiac disease * Known history of human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Tumor Response Categories | Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days | 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. |
| Time to Progression (TTP) | Time from randomization to documented tumor progression (median time of 148 days) | 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. |
| Duration of Response (DOR) | Time from initial response to documented tumor progression or death (median time of 188 days) | 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. |
| Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days | 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). |
| Overall Survival (OS) | Time from randomization to death (the maximum treatment duration of 71.1 weeks) | 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. |
| Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days | 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 European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days | 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 European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days | 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 European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the Visit at Which Best Response Was First Noted | Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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. | 50 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active Follow-up | Disease progression/recurrence/replace | 1 | 0 |
| Active Follow-up | Other reasons | 0 | 2 |
| Double-blind (DB) Treatment | Adverse Event | 3 | 0 |
| Double-blind (DB) Treatment | Death | 1 | 0 |
| Double-blind (DB) Treatment | other reasons | 2 | 3 |
| Double-blind (DB) Treatment | Progression by clinical judgement | 2 | 1 |
| Double-blind (DB) Treatment | Radiological and symptomatic progression | 34 | 41 |
| Double-blind (DB) Treatment | Withdrawal by Subject | 0 | 2 |
| Long Term Follow-up | Death | 19 | 17 |
Baseline characteristics
| Characteristic | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine | Total |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 12.7 | 60.1 years STANDARD_DEVIATION 13.8 | 58.3 years STANDARD_DEVIATION 13.3 |
| Age, Customized >=65 and <75 years | 11 participants | 8 participants | 19 participants |
| Age, Customized <65 years | 36 participants | 33 participants | 69 participants |
| Age, Customized >=75 years | 4 participants | 9 participants | 13 participants |
| American Joint Committee on Cancer (AJCC) Stage at Study Entry Stage III | 2 participants | 1 participants | 3 participants |
| American Joint Committee on Cancer (AJCC) Stage at Study Entry Stage IV M1a | 3 participants | 7 participants | 10 participants |
| American Joint Committee on Cancer (AJCC) Stage at Study Entry Stage IV M1b | 18 participants | 17 participants | 35 participants |
| American Joint Committee on Cancer (AJCC) Stage at Study Entry Stage IV M1c | 28 participants | 25 participants | 53 participants |
| Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status Status 0 | 31 participants | 31 participants | 62 participants |
| Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status Status 1 | 20 participants | 19 participants | 39 participants |
| Lactate dehydrogenase (LDH) at study entry High | 12 participants | 17 participants | 29 participants |
| Lactate dehydrogenase (LDH) at study entry Low | 1 participants | 2 participants | 3 participants |
| Lactate dehydrogenase (LDH) at study entry Missing | 5 participants | 2 participants | 7 participants |
| Lactate dehydrogenase (LDH) at study entry Normal | 33 participants | 29 participants | 62 participants |
| Sex: Female, Male Female | 13 Participants | 17 Participants | 30 Participants |
| Sex: Female, Male Male | 38 Participants | 33 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 49 / 51 | 45 / 50 |
| serious Total, serious adverse events | 22 / 51 | 14 / 50 |
Outcome results
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.
Time frame: Time from randomization to documented tumor progression or death (the maximum treatment duration of 71.1 weeks)
Population: PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Progression Free Survival (PFS) | 148 days |
| Placebo + Dacarbazine | Progression Free Survival (PFS) | 82 days |
p-value: 0.06895% CI: [0.428, 1.034]log rank test
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).
Time frame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Population: Change in ECOG performance status was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | missing | 1 participants |
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | better | 1 participants |
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | no change | 34 participants |
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | worse | 15 participants |
| Placebo + Dacarbazine | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | worse | 13 participants |
| Placebo + Dacarbazine | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | missing | 1 participants |
| Placebo + Dacarbazine | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | no change | 34 participants |
| Placebo + Dacarbazine | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted | better | 2 participants |
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.
Time frame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Population: Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment | -0.015 scores on a scale | Standard Deviation 0.124 |
| Placebo + Dacarbazine | Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment | -0.019 scores on a scale | Standard Deviation 0.161 |
p-value: 0.89t-test, 2 sided
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.
Time frame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Population: Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | 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 | -0.004 scores on a scale | Standard Deviation 0.142 |
| Placebo + Dacarbazine | 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 | -0.008 scores on a scale | Standard Deviation 0.125 |
p-value: 0.908t-test, 2 sided
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.
Time frame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Population: Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment | -2.00 scores on a scale | Standard Deviation 19.612 |
| Placebo + Dacarbazine | Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment | -8.146 scores on a scale | Standard Deviation 20.905 |
p-value: 0.168t-test, 2 sided
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.
Time frame: Baseline and every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Population: Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted | 0.558 scores on a scale | Standard Deviation 17.86 |
| Placebo + Dacarbazine | Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted | -4.425 scores on a scale | Standard Deviation 17.28 |
p-value: 0.201t-test, 2 sided
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.
Time frame: Time from initial response to documented tumor progression or death (median time of 188 days)
Population: DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Duration of Response (DOR) | 188 days |
| Placebo + Dacarbazine | Duration of Response (DOR) | 161 days |
p-value: 0.19495% CI: [0.114, 1.601]log rank test
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.
Time frame: Every 6 weeks from the start of the treatment until the end of treatment visit with a median of 134 days
Population: Tumor response was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Number of Participants in Tumor Response Categories | PR | 12 participants |
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Number of Participants in Tumor Response Categories | PD | 15 participants |
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Number of Participants in Tumor Response Categories | SD | 24 participants |
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Number of Participants in Tumor Response Categories | Not Evaluated | 0 participants |
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Number of Participants in Tumor Response Categories | CR | 0 participants |
| Placebo + Dacarbazine | Number of Participants in Tumor Response Categories | Not Evaluated | 1 participants |
| Placebo + Dacarbazine | Number of Participants in Tumor Response Categories | CR | 0 participants |
| Placebo + Dacarbazine | Number of Participants in Tumor Response Categories | PR | 6 participants |
| Placebo + Dacarbazine | Number of Participants in Tumor Response Categories | SD | 22 participants |
| Placebo + Dacarbazine | Number of Participants in Tumor Response Categories | PD | 21 participants |
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.
Time frame: Time from randomization to death (the maximum treatment duration of 71.1 weeks)
Population: OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Overall Survival (OS) | 319 days |
| Placebo + Dacarbazine | Overall Survival (OS) | 359 days |
p-value: 0.97395% CI: [0.627, 1.57]log rank test
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.
Time frame: Time from randomization to documented tumor progression (median time of 148 days)
Population: TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Time to Progression (TTP) | 148 days |
| Placebo + Dacarbazine | Time to Progression (TTP) | 82 days |
p-value: 0.03995% CI: [0.391, 0.98]log rank test