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Trial record 55 of 519 for:    melanoma phase III

A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00111007
Recruitment Status : Completed
First Posted : May 17, 2005
Results First Posted : February 23, 2011
Last Update Posted : October 31, 2014
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Melanoma
Interventions Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Carboplatin/Paclitaxel
Drug: Placebo
Enrollment 270
Recruitment Details The study was conducted from May 4 2005 to Jan 08 2009 (first subject’s first visit to last subject's last visit) at 54 centers in 7 countries: Australia (6), Canada (6), France (6), Germany (10), Netherlands (2), United Kingdom (8), and United States (16).
Pre-assignment Details Of 315 screened subjects, 270 were randomized (45 failed screening) and were valid for Intent-To-Treat (ITT) analyses (135 in each treatment group). One subject in each group did not receive treatment: 1 died and 1 withdrew consent. Thus, 268 subjects received treatment (134 in each group) and were valid for the safety analyses.
Arm/Group Title Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Hide Arm/Group Description Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) 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 bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) 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 135 [1] 135 [1]
Received Treatment 134 [2] 134 [2]
Completed 27 24
Not Completed 108 111
Reason Not Completed
Adverse Event             12             4
Death             5             2
Protocol Violation             0             1
Withdrawal by Subject             6             8
Disease progression/recurrence/relapse             1             0
Relapse             1             0
Progression by clinical judgement             0             2
Radiological and symptomatic progression             83             93
Primary reason with other category             0             1
[1]
ITT population
[2]
Safety population
Period Title: Active Follow-up
Started 6 [1] 4 [1]
Completed 0 2
Not Completed 6 2
Reason Not Completed
Adverse Event             1             0
Death             2             0
Disease progression/recurrence/relapse             3             2
[1]
Subjects discontinued DB treatment with CR, PR and SD entered this period.
Period Title: Long Term Follow-up
Started 101 [1] 107 [1]
Completed 54 62
Not Completed 47 45
Reason Not Completed
Death             34             39
Lost to Follow-up             1             1
Withdrawal by Subject             0             1
Disease progression/recurrence/relapse             2             1
Missing             10             3
[1]
Subjects discontinued DB treatment with DP entered this period.
Arm/Group Title Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P) Total
Hide Arm/Group Description Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) 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 bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) 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 Number of Baseline Participants 135 135 270
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants 135 participants 270 participants
56.0  (12.8) 55.1  (13.0) 55.5  (57.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 135 participants 270 participants
<65 years 97 92 189
65 to 74 years 29 39 68
>=75 years 9 4 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 135 participants 270 participants
Female
51
  37.8%
48
  35.6%
99
  36.7%
Male
84
  62.2%
87
  64.4%
171
  63.3%
American Joint Committee on Cancer (AJCC) Stage at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 135 participants 270 participants
Stage III or IV M1a 16 11 27
Stage IV M1b 27 31 58
Stage IV M1c 92 93 185
[1]
Measure Description: 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.
Baseline Eastern Cooperative Oncology Group (ECOG) Performance   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 135 participants 270 participants
Status 0 76 70 146
Status 1 59 65 124
[1]
Measure Description: 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). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare; 3= Capable of limited selfcare; 4= Completely disabled; 5= Dead. Subjects entering this study must have had an ECOG score of 0 or 1 (restricted in physically strenuous activity but ambulatory).
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide 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 (median time of 124 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PFS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.
Arm/Group Title Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Hide Arm/Group Description:
Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) 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 bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) 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.
Overall Number of Participants Analyzed 135 135
Median (95% Confidence Interval)
Unit of Measure: days
122
(83 to 162)
125
(79 to 160)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib (Nexavar, BAY43-9006), Carboplatin/Paclitaxel (C/P)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments [Not Specified]
Method log rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.906
Confidence Interval (2-Sided) 95%
0.627 to 1.310
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide 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 (median time of 294 days)
Hide Outcome Measure Data
Hide Analysis Population Description
OS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.
Arm/Group Title Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Hide Arm/Group Description:
Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) 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 bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) 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.
Overall Number of Participants Analyzed 135 135
Median (95% Confidence Interval)
Unit of Measure: days
294
(247 to 321)
294
(259 to 382)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib (Nexavar, BAY43-9006), Carboplatin/Paclitaxel (C/P)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments [Not Specified]
Method log rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.996
Confidence Interval (2-Sided) 95%
0.744 to 1.333
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP was calculated as the time (days) from date of randomization to date of first observed disease progression (DP) (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 126 days)
Hide Outcome Measure Data
Hide Analysis Population Description
TTP was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.
Arm/Group Title Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Hide Arm/Group Description:
Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) 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 bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) 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.
Overall Number of Participants Analyzed 135 135
Median (95% Confidence Interval)
Unit of Measure: days
126
(90 to 167)
126
(83 to 160)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib (Nexavar, BAY43-9006), Carboplatin/Paclitaxel (C/P)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.331
Comments [Not Specified]
Method log rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.863
Confidence Interval (2-Sided) 95%
0.641 to 1.162
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response (DOR)
Hide 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 197 days)
Hide Outcome Measure Data
Hide Analysis Population Description
DOR was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.
Arm/Group Title Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Hide Arm/Group Description:
Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) 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 bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) 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.
Overall Number of Participants Analyzed 135 135
Median (Full Range)
Unit of Measure: days
228
(42 to 420)
166
(46 to 209)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib (Nexavar, BAY43-9006), Carboplatin/Paclitaxel (C/P)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.146
Comments [Not Specified]
Method log rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.398
Confidence Interval (2-Sided) 95%
0.110 to 1.437
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noted
Hide 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 at visit when best response was noted (maximum treatment duration of 68.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Change in ECOG PS was analyzed for the intent to treat (ITT) population, defined as all subjects randomized to treatment. For the ITT population, subjects were included in the treatment group assigned at randomization, regardless of the treatment received.
Arm/Group Title Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Hide Arm/Group Description:
Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) 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 bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) 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.
Overall Number of Participants Analyzed 135 135
Measure Type: Number
Unit of Measure: participants
missing 10 4
better 9 10
no change 70 82
worse 46 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib (Nexavar, BAY43-9006), Carboplatin/Paclitaxel (C/P)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Abbreviations used in the Adverse Events section: Absolute Neutrophil Count (ANC), Aspartate Aminotransferase (AST), Central Nervous System (CNS), Common Terminology Criteria for Adverse Events (CTCAE), Gastro-Intestinal (GI), Genito-Urinary (GU), National Cancer Institute (NCI), Not Otherwise Specified (NOS)
 
Arm/Group Title Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Hide Arm/Group Description Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) 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 bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) 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) Carboplatin/Paclitaxel (C/P)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Affected / at Risk (%) Affected / at Risk (%)
Total   66/134 (49.25%)   65/134 (48.51%) 
Blood and lymphatic system disorders     
neutrophils * 1  15/134 (11.19%)  7/134 (5.22%) 
hemoglobin * 1  3/134 (2.24%)  8/134 (5.97%) 
platelets * 1  0/134 (0.00%)  3/134 (2.24%) 
leukocytes * 1  2/134 (1.49%)  1/134 (0.75%) 
Cardiac disorders     
supraventricular arrhythmia, atrial flutter * 1  1/134 (0.75%)  1/134 (0.75%) 
supraventricular arrhythmia, supraventricular extrasystoles (pac; premature nodal/junction contr) * 1  0/134 (0.00%)  1/134 (0.75%) 
supraventricular arrhythmia, supraventricular arrhythmia NOS * 1  1/134 (0.75%)  0/134 (0.00%) 
tachycardia * 1  0/134 (0.00%)  1/134 (0.75%) 
vasovagal episode * 1  0/134 (0.00%)  1/134 (0.75%) 
hypotension * 1  1/134 (0.75%)  2/134 (1.49%) 
cardiac ischemia / infarction * 1  2/134 (1.49%)  0/134 (0.00%) 
cardiac general - other * 1  0/134 (0.00%)  0/134 (0.00%) 
left ventricular diastolic dysfunction * 1  0/134 (0.00%)  1/134 (0.75%) 
pericarditis * 1  0/134 (0.00%)  1/134 (0.75%) 
Endocrine disorders     
diabetes * 1  1/134 (0.75%)  0/134 (0.00%) 
Gastrointestinal disorders     
vomiting * 1  1/134 (0.75%)  4/134 (2.99%) 
diarrhea * 1  2/134 (1.49%)  2/134 (1.49%) 
dehydration * 1  1/134 (0.75%)  2/134 (1.49%) 
obstruction, GI, small bowel NOS * 1  1/134 (0.75%)  2/134 (1.49%) 
anorexia * 1  0/134 (0.00%)  2/134 (1.49%) 
constipation * 1  2/134 (1.49%)  0/134 (0.00%) 
nausea * 1  1/134 (0.75%)  1/134 (0.75%) 
colitis * 1  0/134 (0.00%)  1/134 (0.75%) 
esophagitis * 1  0/134 (0.00%)  1/134 (0.75%) 
fistula, GI, esophagus * 1  0/134 (0.00%)  1/134 (0.75%) 
General disorders     
death not associated with CTCAE term, disease progression NOS * 1  2/134 (1.49%)  1/134 (0.75%) 
death not associated with CTCAE term, death NOS * 1  1/134 (0.75%)  0/134 (0.00%) 
fever * 1  3/134 (2.24%)  5/134 (3.73%) 
fatigue * 1  2/134 (1.49%)  4/134 (2.99%) 
constitutional symptoms - other * 1  1/134 (0.75%)  4/134 (2.99%) 
pain, abdomen NOS * 1  2/134 (1.49%)  4/134 (2.99%) 
pain, pain NOS * 1  3/134 (2.24%)  1/134 (0.75%) 
pain, chest / thorax NOS * 1  2/134 (1.49%)  0/134 (0.00%) 
pain, tumor pain * 1  0/134 (0.00%)  1/134 (0.75%) 
pain, joint * 1  1/134 (0.75%)  0/134 (0.00%) 
pain, muscle * 1  0/134 (0.00%)  1/134 (0.75%) 
no code in CTCAE * 1  1/134 (0.75%)  0/134 (0.00%) 
Hepatobiliary disorders     
liver dysfunction * 1  1/134 (0.75%)  1/134 (0.75%) 
cholecystitis * 1  1/134 (0.75%)  0/134 (0.00%) 
Immune system disorders     
allergic reaction * 1  4/134 (2.99%)  2/134 (1.49%) 
Infections and infestations     
febrile neutropenia * 1  10/134 (7.46%)  8/134 (5.97%) 
infection with unknown ANC, lung (pneumonia) * 1  1/134 (0.75%)  3/134 (2.24%) 
infection with unknown ANC, skin (cellulitis) * 1  2/134 (1.49%)  1/134 (0.75%) 
infection with normal ANC, upper airway NOS * 1  1/134 (0.75%)  1/134 (0.75%) 
infection - other * 1  0/134 (0.00%)  2/134 (1.49%) 
infection (documented clinically), upper airway NOS * 1  1/134 (0.75%)  0/134 (0.00%) 
infection with normal ANC, blood * 1  0/134 (0.00%)  1/134 (0.75%) 
infection with normal ANC, lung (pneumonia) * 1  0/134 (0.00%)  1/134 (0.75%) 
infection with normal ANC, soft tissue NOS * 1  0/134 (0.00%)  1/134 (0.75%) 
infection with normal ANC, vein * 1  1/134 (0.75%)  0/134 (0.00%) 
infection with normal ANC, wound * 1  0/134 (0.00%)  1/134 (0.75%) 
Injury, poisoning and procedural complications     
intraop injury, bone * 1  0/134 (0.00%)  1/134 (0.75%) 
Metabolism and nutrition disorders     
hyperglycemia * 1  0/134 (0.00%)  3/134 (2.24%) 
AST * 1  0/134 (0.00%)  1/134 (0.75%) 
hypoglycemia * 1  0/134 (0.00%)  1/134 (0.75%) 
hyponatremia * 1  1/134 (0.75%)  0/134 (0.00%) 
Musculoskeletal and connective tissue disorders     
muscle weakness, whole body / generalized * 1  1/134 (0.75%)  0/134 (0.00%) 
Nervous system disorders     
seizure * 1  1/134 (0.75%)  6/134 (4.48%) 
confusion * 1  0/134 (0.00%)  2/134 (1.49%) 
neuropathy: motor * 1  2/134 (1.49%)  0/134 (0.00%) 
CNS ischemia * 1  1/134 (0.75%)  0/134 (0.00%) 
speech impairment * 1  1/134 (0.75%)  0/134 (0.00%) 
neurology - other * 1  0/134 (0.00%)  1/134 (0.75%) 
neuropathy: sensory * 1  1/134 (0.75%)  0/134 (0.00%) 
somnolence * 1  1/134 (0.75%)  0/134 (0.00%) 
syncope (fainting) * 1  0/134 (0.00%)  1/134 (0.75%) 
Respiratory, thoracic and mediastinal disorders     
dyspnea (shortness of breath) * 1  1/134 (0.75%)  2/134 (1.49%) 
pulmonary - other * 1  1/134 (0.75%)  1/134 (0.75%) 
aspiration * 1  1/134 (0.75%)  0/134 (0.00%) 
pleural effusion * 1  1/134 (0.75%)  0/134 (0.00%) 
Skin and subcutaneous tissue disorders     
erythema multiforme * 1  2/134 (1.49%)  0/134 (0.00%) 
hand - foot skin reaction * 1  1/134 (0.75%)  0/134 (0.00%) 
rash / desquamation * 1  1/134 (0.75%)  0/134 (0.00%) 
ulceration * 1  1/134 (0.75%)  0/134 (0.00%) 
Vascular disorders     
CNS hemorrhage * 1  2/134 (1.49%)  2/134 (1.49%) 
hemorrhage - other * 1  1/134 (0.75%)  1/134 (0.75%) 
hemorrhage, GI, lower GI NOS * 1  0/134 (0.00%)  1/134 (0.75%) 
hemorrhage with surgery * 1  1/134 (0.75%)  0/134 (0.00%) 
hemorrhage pulmonary, respiratory tract NOS * 1  1/134 (0.75%)  0/134 (0.00%) 
hemorrhage, GU, bladder * 1  0/134 (0.00%)  1/134 (0.75%) 
hemorrhage, GU, urinary NOS * 1  0/134 (0.00%)  1/134 (0.75%) 
thrombosis / thrombus / embolism * 1  3/134 (2.24%)  9/134 (6.72%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI-CTCAE v.3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sorafenib (Nexavar, BAY43-9006) Carboplatin/Paclitaxel (C/P)
Affected / at Risk (%) Affected / at Risk (%)
Total   132/134 (98.51%)   134/134 (100.00%) 
Blood and lymphatic system disorders     
neutrophils * 1  68/134 (50.75%)  71/134 (52.99%) 
platelets * 1  62/134 (46.27%)  40/134 (29.85%) 
hemoglobin * 1  33/134 (24.63%)  44/134 (32.84%) 
leukocytes * 1  36/134 (26.87%)  38/134 (28.36%) 
lymphopenia * 1  8/134 (5.97%)  5/134 (3.73%) 
edema: limb * 1  14/134 (10.45%)  18/134 (13.43%) 
Cardiac disorders     
hypertension * 1  11/134 (8.21%)  6/134 (4.48%) 
Eye disorders     
blurred vision * 1  8/134 (5.97%)  11/134 (8.21%) 
Gastrointestinal disorders     
nausea * 1  71/134 (52.99%)  72/134 (53.73%) 
diarrhea * 1  64/134 (47.76%)  36/134 (26.87%) 
constipation * 1  40/134 (29.85%)  42/134 (31.34%) 
vomiting * 1  33/134 (24.63%)  32/134 (23.88%) 
anorexia * 1  32/134 (23.88%)  15/134 (11.19%) 
mucositis (functional / symptomatic), oral cavity * 1  17/134 (12.69%)  11/134 (8.21%) 
taste alteration * 1  11/134 (8.21%)  13/134 (9.70%) 
heartburn * 1  12/134 (8.96%)  11/134 (8.21%) 
GI - other * 1  13/134 (9.70%)  6/134 (4.48%) 
dry mouth * 1  7/134 (5.22%)  3/134 (2.24%) 
flatulence * 1  7/134 (5.22%)  3/134 (2.24%) 
General disorders     
fatigue * 1  102/134 (76.12%)  79/134 (58.96%) 
insomnia * 1  26/134 (19.40%)  25/134 (18.66%) 
fever * 1  16/134 (11.94%)  11/134 (8.21%) 
sweating * 1  10/134 (7.46%)  16/134 (11.94%) 
weight loss * 1  16/134 (11.94%)  9/134 (6.72%) 
rigors / chills * 1  10/134 (7.46%)  8/134 (5.97%) 
constitutional symptoms - other * 1  3/134 (2.24%)  7/134 (5.22%) 
pain, joint * 1  44/134 (32.84%)  37/134 (27.61%) 
pain, muscle * 1  35/134 (26.12%)  27/134 (20.15%) 
pain, extremity - limb * 1  25/134 (18.66%)  23/134 (17.16%) 
pain, abdomen NOS * 1  19/134 (14.18%)  23/134 (17.16%) 
pain, head / headache * 1  21/134 (15.67%)  20/134 (14.93%) 
pain, back * 1  12/134 (8.96%)  18/134 (13.43%) 
pain, bone * 1  13/134 (9.70%)  17/134 (12.69%) 
pain, pain NOS * 1  13/134 (9.70%)  12/134 (8.96%) 
pain, throat / pharynx / larynx * 1  11/134 (8.21%)  6/134 (4.48%) 
pain, chest / thorax NOS * 1  10/134 (7.46%)  5/134 (3.73%) 
Immune system disorders     
allergic reaction * 1  8/134 (5.97%)  10/134 (7.46%) 
Infections and infestations     
infection - other * 1  7/134 (5.22%)  8/134 (5.97%) 
infection with normal ANC, upper airway NOS * 1  7/134 (5.22%)  6/134 (4.48%) 
infection with unknown ANC, skin (cellulitis) * 1  7/134 (5.22%)  0/134 (0.00%) 
Metabolism and nutrition disorders     
hypokalemia * 1  9/134 (6.72%)  11/134 (8.21%) 
hypomagnesemia * 1  5/134 (3.73%)  10/134 (7.46%) 
hypophosphatemia * 1  8/134 (5.97%)  4/134 (2.99%) 
lipase * 1  7/134 (5.22%)  3/134 (2.24%) 
Musculoskeletal and connective tissue disorders     
musculoskeletal - other * 1  8/134 (5.97%)  6/134 (4.48%) 
Nervous system disorders     
neuropathy: sensory * 1  89/134 (66.42%)  87/134 (64.93%) 
dizziness * 1  21/134 (15.67%)  19/134 (14.18%) 
mood alteration, depression * 1  9/134 (6.72%)  11/134 (8.21%) 
neuropathy: motor * 1  7/134 (5.22%)  5/134 (3.73%) 
neurology - other * 1  8/134 (5.97%)  4/134 (2.99%) 
Respiratory, thoracic and mediastinal disorders     
cough * 1  29/134 (21.64%)  25/134 (18.66%) 
dyspnea (shortness of breath) * 1  20/134 (14.93%)  24/134 (17.91%) 
voice changes * 1  10/134 (7.46%)  4/134 (2.99%) 
hiccoughs * 1  9/134 (6.72%)  4/134 (2.99%) 
pulmonary - other * 1  4/134 (2.99%)  9/134 (6.72%) 
Skin and subcutaneous tissue disorders     
alopecia * 1  90/134 (67.16%)  87/134 (64.93%) 
rash / desquamation * 1  79/134 (58.96%)  29/134 (21.64%) 
hand - foot skin reaction * 1  38/134 (28.36%)  8/134 (5.97%) 
pruritus * 1  34/134 (25.37%)  12/134 (8.96%) 
dermatology - other * 1  19/134 (14.18%)  6/134 (4.48%) 
dry skin * 1  16/134 (11.94%)  5/134 (3.73%) 
erythema multiforme * 1  12/134 (8.96%)  8/134 (5.97%) 
flushing * 1  6/134 (4.48%)  7/134 (5.22%) 
injection site reaction * 1  7/134 (5.22%)  5/134 (3.73%) 
acne * 1  1/134 (0.75%)  9/134 (6.72%) 
urticaria * 1  8/134 (5.97%)  1/134 (0.75%) 
Vascular disorders     
hemorrhage pulmonary, nose * 1  18/134 (13.43%)  10/134 (7.46%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI-CTCAE v.3.0
Metastatic melanoma is notorious for its resistance to chemotherapy. Thus, it is unlikely that inhibition of a single factor or pathway would produce a sustained clinical effect in patients with previously treated, highly refractory disease.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00111007     History of Changes
Obsolete Identifiers: NCT00262912
Other Study ID Numbers: 11718
2005-000941-12 ( EudraCT Number )
First Submitted: May 16, 2005
First Posted: May 17, 2005
Results First Submitted: January 27, 2011
Results First Posted: February 23, 2011
Last Update Posted: October 31, 2014