Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00110994
Collaborator
Amgen (Industry)
101
14
2
35
7.2
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
101 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase II Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine (DTIC) Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
Study Start Date
:
Apr 1, 2005
Actual Primary Completion Date
:
Oct 1, 2006
Actual Study Completion Date
:
Mar 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21
Drug: Dacarbazine
Dacarbazine, 1000 mg/m^2 intravenous on Study Day 1
|
| Active Comparator: 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. |
Drug: Placebo
Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21
Drug: Dacarbazine
Dacarbazine, 1000 mg/m^2 intravenous on Study Day 1
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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).
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tucson | Arizona | United States | 85724 | |
| 2 | Aurora | Colorado | United States | 80045 | |
| 3 | Lakeland | Florida | United States | 33805 | |
| 4 | Park Ridge | Illinois | United States | 60068 | |
| 5 | Boston | Massachusetts | United States | 02114 | |
| 6 | Boston | Massachusetts | United States | 02115-6084 | |
| 7 | Boston | Massachusetts | United States | 02215 | |
| 8 | St. Louis | Missouri | United States | 63110-1093 | |
| 9 | Omaha | Nebraska | United States | 68114 | |
| 10 | Charlotte | North Carolina | United States | 28203 | |
| 11 | Pittsburgh | Pennsylvania | United States | 15232 | |
| 12 | Hilton Head Island | South Carolina | United States | 29926-2739 | |
| 13 | Nashville | Tennessee | United States | 37232-6307 | |
| 14 | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Bayer
- Amgen
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00110994
Other Study ID Numbers:
- 11715
First Posted:
May 17, 2005
Last Update Posted:
Jun 8, 2015
Last Verified:
May 1, 2015
Study Results
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 Detail | 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. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Period Title: Double-blind (DB) Treatment | ||
| STARTED | 51 | 50 |
| Received Treatment | 51 | 50 |
| COMPLETED | 9 | 3 |
| NOT COMPLETED | 42 | 47 |
| Period Title: Double-blind (DB) Treatment | ||
| STARTED | 1 | 2 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 1 | 2 |
| Period Title: Double-blind (DB) Treatment | ||
| STARTED | 41 | 47 |
| COMPLETED | 22 | 30 |
| NOT COMPLETED | 19 | 17 |
Baseline Characteristics
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine | Total |
|---|---|---|---|
| Arm/Group Description | 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, 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. | Total of all reporting groups |
| Overall Participants | 51 | 50 | 101 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
56.5
(12.7)
|
60.1
(13.8)
|
58.3
(13.3)
|
| Age, Customized (participants) [Number] | |||
| <65 years |
36
70.6%
|
33
66%
|
69
68.3%
|
| >=65 and <75 years |
11
21.6%
|
8
16%
|
19
18.8%
|
| >=75 years |
4
7.8%
|
9
18%
|
13
12.9%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
13
25.5%
|
17
34%
|
30
29.7%
|
| Male |
38
74.5%
|
33
66%
|
71
70.3%
|
| American Joint Committee on Cancer (AJCC) Stage at Study Entry (participants) [Number] | |||
| Stage III |
2
3.9%
|
1
2%
|
3
3%
|
| Stage IV M1a |
3
5.9%
|
7
14%
|
10
9.9%
|
| Stage IV M1b |
18
35.3%
|
17
34%
|
35
34.7%
|
| Stage IV M1c |
28
54.9%
|
25
50%
|
53
52.5%
|
| Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status (participants) [Number] | |||
| Status 0 |
31
60.8%
|
31
62%
|
62
61.4%
|
| Status 1 |
20
39.2%
|
19
38%
|
39
38.6%
|
| Lactate dehydrogenase (LDH) at study entry (participants) [Number] | |||
| Normal |
33
64.7%
|
29
58%
|
62
61.4%
|
| Low |
1
2%
|
2
4%
|
3
3%
|
| High |
12
23.5%
|
17
34%
|
29
28.7%
|
| Missing |
5
9.8%
|
2
4%
|
7
6.9%
|
Outcome Measures
| Title | Progression Free Survival (PFS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| Median (95% Confidence Interval) [days] |
148
|
82
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine, Placebo + Dacarbazine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.068 |
| Comments | ||
| Method | log rank test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.665 | |
| Confidence Interval |
(2-Sided) 95% 0.428 to 1.034 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Overall Survival (OS) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| Median (95% Confidence Interval) [days] |
319
|
359
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine, Placebo + Dacarbazine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.973 |
| Comments | ||
| Method | log rank test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.992 | |
| Confidence Interval |
(2-Sided) 95% 0.627 to 1.570 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants in Tumor Response Categories |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Tumor response was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| CR |
0
0%
|
0
0%
|
| PR |
12
23.5%
|
6
12%
|
| SD |
24
47.1%
|
22
44%
|
| PD |
15
29.4%
|
21
42%
|
| Not Evaluated |
0
0%
|
1
2%
|
| Title | Time to Progression (TTP) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| Median (95% Confidence Interval) [days] |
148
|
82
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine, Placebo + Dacarbazine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | ||
| Method | log rank test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.619 | |
| Confidence Interval |
(2-Sided) 95% 0.391 to 0.980 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Duration of Response (DOR) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| Median (95% Confidence Interval) [days] |
188
|
161
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine, Placebo + Dacarbazine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.194 |
| Comments | ||
| Method | log rank test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.427 | |
| Confidence Interval |
(2-Sided) 95% 0.114 to 1.601 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to the Visit When the Best Tumor Response Was Noted |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in ECOG performance status was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| missing |
1
2%
|
1
2%
|
| better |
1
2%
|
2
4%
|
| no change |
34
66.7%
|
34
68%
|
| worse |
15
29.4%
|
13
26%
|
| Title | 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 |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| Mean (Standard Deviation) [scores on a scale] |
-0.004
(0.142)
|
-0.008
(0.125)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine, Placebo + Dacarbazine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.908 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change of European Quality of Life 5-dimensional (EQ-5D) Questionnaire Index Score From Baseline to the End of Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change of EQ-5D questionnaire index score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| Mean (Standard Deviation) [scores on a scale] |
-0.015
(0.124)
|
-0.019
(0.161)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine, Placebo + Dacarbazine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.890 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the Visit at Which Best Response Was First Noted |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| Mean (Standard Deviation) [scores on a scale] |
0.558
(17.86)
|
-4.425
(17.28)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine, Placebo + Dacarbazine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.201 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change of European Quality of Life Visual Analogue Scale (EQ-VAS) Score From Baseline to the End of Treatment |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change of EQ-VAS score was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. |
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine |
|---|---|---|
| Arm/Group Description | 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, 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. |
| Measure Participants | 51 | 50 |
| Mean (Standard Deviation) [scores on a scale] |
-2.00
(19.612)
|
-8.146
(20.905)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine, Placebo + Dacarbazine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.168 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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) | |||
| Arm/Group Title | Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine | ||
| Arm/Group Description | 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, 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. | ||
All Cause Mortality |
||||
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/51 (43.1%) | 14/50 (28%) | ||
| Blood and lymphatic system disorders | ||||
| platelets | 1/51 (2%) | 1/50 (2%) | ||
| neutrophils | 0/51 (0%) | 1/50 (2%) | ||
| hemoglobin | 0/51 (0%) | 1/50 (2%) | ||
| leukocytes | 1/51 (2%) | 0/50 (0%) | ||
| Cardiac disorders | ||||
| supraventricular arrhythmia, atrial fibrillation | 1/51 (2%) | 0/50 (0%) | ||
| supraventricular arrhythmia, supraventricular tachycardia | 0/51 (0%) | 1/50 (2%) | ||
| hypotension | 4/51 (7.8%) | 0/50 (0%) | ||
| cardiac ischemia / infarction | 2/51 (3.9%) | 0/50 (0%) | ||
| cardiopulmonary arrest | 0/51 (0%) | 1/50 (2%) | ||
| hypertension | 1/51 (2%) | 0/50 (0%) | ||
| Eye disorders | ||||
| blurred vision | 1/51 (2%) | 0/50 (0%) | ||
| Gastrointestinal disorders | ||||
| vomiting | 3/51 (5.9%) | 1/50 (2%) | ||
| nausea | 2/51 (3.9%) | 1/50 (2%) | ||
| ascites | 1/51 (2%) | 0/50 (0%) | ||
| constipation | 0/51 (0%) | 1/50 (2%) | ||
| dehydration | 0/51 (0%) | 1/50 (2%) | ||
| General disorders | ||||
| death not associated with CTCAE term, disease progression NOS | 2/51 (3.9%) | 1/50 (2%) | ||
| death not associated with CTCAE term, multi-organ failure | 1/51 (2%) | 0/50 (0%) | ||
| fever | 2/51 (3.9%) | 1/50 (2%) | ||
| constitutional symptoms - other | 1/51 (2%) | 2/50 (4%) | ||
| rigors / chills | 0/51 (0%) | 1/50 (2%) | ||
| pain, chest / thorax NOS | 1/51 (2%) | 1/50 (2%) | ||
| pain, abdomen NOS | 1/51 (2%) | 1/50 (2%) | ||
| pain, extremity - limb | 0/51 (0%) | 1/50 (2%) | ||
| pain, head / headache | 1/51 (2%) | 0/50 (0%) | ||
| pain, muscle | 0/51 (0%) | 1/50 (2%) | ||
| pain, pain NOS | 1/51 (2%) | 0/50 (0%) | ||
| no code in CTCAE | 1/51 (2%) | 0/50 (0%) | ||
| Hepatobiliary disorders | ||||
| cholecystitis | 2/51 (3.9%) | 0/50 (0%) | ||
| liver dysfunction | 1/51 (2%) | 0/50 (0%) | ||
| pancreatitis | 1/51 (2%) | 0/50 (0%) | ||
| Infections and infestations | ||||
| infection - other | 1/51 (2%) | 1/50 (2%) | ||
| infection with unknown ANC, skin (cellulitis) | 0/51 (0%) | 1/50 (2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| fracture | 2/51 (3.9%) | 0/50 (0%) | ||
| Nervous system disorders | ||||
| CNS ischemia | 0/51 (0%) | 1/50 (2%) | ||
| dizziness | 1/51 (2%) | 0/50 (0%) | ||
| neurology - other | 1/51 (2%) | 0/50 (0%) | ||
| psychosis | 0/51 (0%) | 1/50 (2%) | ||
| seizure | 0/51 (0%) | 1/50 (2%) | ||
| Renal and urinary disorders | ||||
| renal failure | 2/51 (3.9%) | 0/50 (0%) | ||
| renal - other | 1/51 (2%) | 0/50 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| dyspnea (shortness of breath) | 1/51 (2%) | 0/50 (0%) | ||
| Vascular disorders | ||||
| CNS hemorrhage | 4/51 (7.8%) | 0/50 (0%) | ||
| hemorrhage, GI, abdomen NOS | 1/51 (2%) | 0/50 (0%) | ||
| hemorrhage, GI, upper GI NOS | 0/51 (0%) | 1/50 (2%) | ||
| hemorrhage - other | 1/51 (2%) | 0/50 (0%) | ||
| hemorrhage pulmonary, nose | 0/51 (0%) | 1/50 (2%) | ||
| thrombosis / thrombus / embolism | 2/51 (3.9%) | 0/50 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Sorafenib (Nexavar, BAY43-9006) + Dacarbazine | Placebo + Dacarbazine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 49/51 (96.1%) | 45/50 (90%) | ||
| Blood and lymphatic system disorders | ||||
| platelets | 30/51 (58.8%) | 14/50 (28%) | ||
| neutrophils | 23/51 (45.1%) | 9/50 (18%) | ||
| hemoglobin | 18/51 (35.3%) | 12/50 (24%) | ||
| leukocytes | 13/51 (25.5%) | 7/50 (14%) | ||
| lymphopenia | 3/51 (5.9%) | 1/50 (2%) | ||
| edema: limb | 3/51 (5.9%) | 0/50 (0%) | ||
| Cardiac disorders | ||||
| hypertension | 5/51 (9.8%) | 0/50 (0%) | ||
| hypotension | 4/51 (7.8%) | 0/50 (0%) | ||
| Gastrointestinal disorders | ||||
| nausea | 29/51 (56.9%) | 26/50 (52%) | ||
| diarrhea | 29/51 (56.9%) | 8/50 (16%) | ||
| anorexia | 17/51 (33.3%) | 11/50 (22%) | ||
| vomiting | 15/51 (29.4%) | 8/50 (16%) | ||
| constipation | 8/51 (15.7%) | 12/50 (24%) | ||
| heartburn | 5/51 (9.8%) | 5/50 (10%) | ||
| GI - other | 6/51 (11.8%) | 2/50 (4%) | ||
| flatulence | 4/51 (7.8%) | 2/50 (4%) | ||
| taste alteration | 5/51 (9.8%) | 1/50 (2%) | ||
| mucositis (functional / symptomatic), oral cavity | 5/51 (9.8%) | 0/50 (0%) | ||
| dry mouth | 3/51 (5.9%) | 0/50 (0%) | ||
| General disorders | ||||
| fatigue | 29/51 (56.9%) | 27/50 (54%) | ||
| weight loss | 9/51 (17.6%) | 4/50 (8%) | ||
| rigors / chills | 5/51 (9.8%) | 3/50 (6%) | ||
| sweating | 5/51 (9.8%) | 2/50 (4%) | ||
| fever | 2/51 (3.9%) | 3/50 (6%) | ||
| pain, head / headache | 10/51 (19.6%) | 7/50 (14%) | ||
| pain, joint | 11/51 (21.6%) | 2/50 (4%) | ||
| pain, muscle | 6/51 (11.8%) | 4/50 (8%) | ||
| pain, extremity - limb | 3/51 (5.9%) | 1/50 (2%) | ||
| pain, pain NOS | 3/51 (5.9%) | 1/50 (2%) | ||
| pain, other | 3/51 (5.9%) | 0/50 (0%) | ||
| Immune system disorders | ||||
| allergic reaction | 3/51 (5.9%) | 0/50 (0%) | ||
| Metabolism and nutrition disorders | ||||
| lipase | 13/51 (25.5%) | 8/50 (16%) | ||
| ALT | 6/51 (11.8%) | 4/50 (8%) | ||
| amylase | 5/51 (9.8%) | 4/50 (8%) | ||
| AST | 4/51 (7.8%) | 3/50 (6%) | ||
| hypokalemia | 3/51 (5.9%) | 1/50 (2%) | ||
| hypophosphatemia | 3/51 (5.9%) | 1/50 (2%) | ||
| metabolic / lab - other | 3/51 (5.9%) | 1/50 (2%) | ||
| hypomagnesemia | 3/51 (5.9%) | 0/50 (0%) | ||
| Nervous system disorders | ||||
| neuropathy: sensory | 8/51 (15.7%) | 7/50 (14%) | ||
| dizziness | 6/51 (11.8%) | 3/50 (6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| voice changes | 3/51 (5.9%) | 1/50 (2%) | ||
| Skin and subcutaneous tissue disorders | ||||
| rash / desquamation | 19/51 (37.3%) | 6/50 (12%) | ||
| pruritus | 12/51 (23.5%) | 2/50 (4%) | ||
| hand-foot skin reaction | 11/51 (21.6%) | 1/50 (2%) | ||
| alopecia | 9/51 (17.6%) | 2/50 (4%) | ||
| injection site reaction | 6/51 (11.8%) | 4/50 (8%) | ||
| dermatology - other | 6/51 (11.8%) | 4/50 (8%) | ||
| flushing | 5/51 (9.8%) | 3/50 (6%) | ||
| dry skin | 3/51 (5.9%) | 2/50 (4%) | ||
| acne | 4/51 (7.8%) | 0/50 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | BAYER |
| Phone | |
| clinical-trials-contact@bayerhealthcare.com |
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00110994
Other Study ID Numbers:
- 11715
First Posted:
May 17, 2005
Last Update Posted:
Jun 8, 2015
Last Verified:
May 1, 2015