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A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma

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: NCT00108953
Recruitment Status : Completed
First Posted : April 22, 2005
Results First Posted : June 11, 2009
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Carcinoma, Hepatocellular
Interventions Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin
Drug: Doxorubicin/Placebo
Enrollment 96
Recruitment Details Enrollment started on 13 Apr 2005 and the last study contact occurred on 11 Apr 2008. The study was conducted at 25 active centers in 6 countries (Argentina, Canada, Hong Kong, Russia, United Kingdom, and United States.)
Pre-assignment Details 140 patients were screened, with 44 screen failures. The intent-to-treat (ITT) population (primary efficacy analysis) includes all randomized patients (96). The Safety population includes all patients who received at least 1 dose of study drug (95). The study consists of 2 periods: treatment period (not fixed but ended by any event) and follow-up.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description "Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks) "Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Period Title: Treatment Period
Started 47 [1] 49 [1]
Completed 47 [2] 49 [2]
Not Completed 0 0
[1]
ITT population
[2]
No patient under study medication anymore
Period Title: Follow-up
Started 40 [1] 45 [2]
Completed 11 12
Not Completed 29 33
Reason Not Completed
Death             18             26
Lost to Follow-up             1             1
Study terminated by sponsor             10             6
[1]
40 out of 47 patients were followed after end of double blind treatment
[2]
45 out of 49 patients were followed after end of double blind treatment
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin Total
Hide Arm/Group Description "Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks) "Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks) Total of all reporting groups
Overall Number of Baseline Participants 47 49 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Median (Full Range) Number Analyzed 47 participants 49 participants 96 participants
66
(38 to 82)
65
(38 to 81)
65
(38 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 49 participants 96 participants
Female
16
  34.0%
7
  14.3%
23
  24.0%
Male
31
  66.0%
42
  85.7%
73
  76.0%
Child Pugh Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 49 participants 96 participants
5 (Child-Pugh A) 30 28 58
6 (Child-Pugh A) 17 19 36
7 (Child-Pugh B) 0 2 2
>7 0 0 0
[1]
Measure Description: The Child-Pugh score is used to classify the stages of liver cirrhosis, based on clinical diagnosis and laboratory tests. Assessment of good operative risk (A) if 5 or 6 points, moderate risk (B) if 7 to 9 points, and poor operative risk (C) if 10 to 15 points. A "C" classification forecasts a survival of less than 12 months.
Eastern Cooperative Group performance status (ECOG PS) at study entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 49 participants 96 participants
Grade 0 22 16 38
Grade 1 18 25 43
Grade 2 4 3 7
Grade 3 0 1 1
missing 3 4 7
[1]
Measure Description: ECOG PS is a rating of daily living abilities, from 0 to 5. 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.
Tumor burden: Extrahepatic spread   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 49 participants 96 participants
yes 24 32 56
no 23 17 40
[1]
Measure Description: Tumor spread outside the liver, which describes an aggressive and advanced tumor pattern.
Tumor burden: Macroscopic vascular invasion   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 49 participants 96 participants
yes 13 16 29
no 33 32 65
missing 1 1 2
[1]
Measure Description: Tumor spread into the blood vessels as determined through radiological assessment (e.g., x-ray, imaging), which describes an aggressive and advanced tumor pattern.
1.Primary Outcome
Title Time to Progression (TTP)
Hide Description TTP was defined as the time from randomization to radiological disease progression by independent assessment.
Time Frame from date of randomization of the first patient until 3 years later
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population, primary population for efficacy analysis, includes all randomized patients.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description:
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Overall Number of Participants Analyzed 47 49
Median (95% Confidence Interval)
Unit of Measure: days
263
(146 to 384)
147
(66 to 244)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib + Doxorubicin, Placebo + Doxorubicin
Comments The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio, log
Estimated Value 0.6
Confidence Interval 95%
0.33 to 0.95
Estimation Comments Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin
2.Secondary Outcome
Title Overall Survival
Hide Description The time from date of randomization to date of death
Time Frame from date of randomization of the first patient until 3 years later
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population, primary population for efficacy analysis, includes all randomized patients. The table below gives the lower and upper limit of the confidence interval; 999999999 = not estimable.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description:
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Overall Number of Participants Analyzed 47 49
Median (95% Confidence Interval)
Unit of Measure: days
418
(317 to 999999999)
199
(148 to 302)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib + Doxorubicin, Placebo + Doxorubicin
Comments The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.52
Confidence Interval 95%
0.37 to 0.74
Estimation Comments Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Time from the date of randomization to the date of the first documented radiological progression (as defined per independent central radiological assessment) or death, whichever occurs first
Time Frame from date of randomization of the first patient until 3 years later
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population, primary population for efficacy analysis, includes all randomized patients.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description:
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Overall Number of Participants Analyzed 47 49
Median (95% Confidence Interval)
Unit of Measure: days
242
(140 to 312)
85
(71 to 172)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib + Doxorubicin, Placebo + Doxorubicin
Comments The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.61
Confidence Interval 95%
0.45 to 0.83
Estimation Comments Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin
4.Secondary Outcome
Title Percentage of Participants in Each Category of Best Tumor Response
Hide Description Percentage of participants with complete or partial response (CR or PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) and achieved during treatment or 30 days after end of treatment. CR: disappearance of all clinical and radiological tumor lesions. PR: at least 30% decrease in sum of the longest diameters of tumor lesions. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
Time Frame achieved during treatment or within 30 days after termination of active therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population, primary population for efficacy analysis, includes all randomized patients.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description:
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Overall Number of Participants Analyzed 47 49
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response (CR) 0.0 2.0
Partial Response (PR) 4.3 0.0
Stable Disease (SD) 66.0 49.0
5.Secondary Outcome
Title Time to Symptomatic Progression (TTSP)
Hide Description Time from date of randomization to date of first documented symptomatic progression defined by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8) assessment
Time Frame from date of randomization of the first patient until 3 years later
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population, primary population for efficacy analysis, includes all randomized patients.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description:
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Overall Number of Participants Analyzed 47 49
Median (95% Confidence Interval)
Unit of Measure: days
208
(85 to 317)
152
(110 to 180)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sorafenib + Doxorubicin, Placebo + Doxorubicin
Comments The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval 95%
0.40 to 1.05
Estimation Comments Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin
6.Secondary Outcome
Title Duration of Response
Hide Description Time from date of first objective response (complete response [CR] or partial response [PR]) to date progression is first documented (as defined per independent central radiological assessment) or death, whichever occurs first
Time Frame from date of randomization of the first patient until 3 years later
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population, primary population for efficacy analysis, includes all randomized patients.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description:
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Overall Number of Participants Analyzed 47 49
Median (Full Range)
Unit of Measure: days
199
(97 to 301)
68
(68 to 68)
7.Secondary Outcome
Title Time to Response (TTR)
Hide Description Time from date of randomization to date of first objective response (complete response [CR] or partial response [PR]) is documented and confirmed according to RECIST criteria
Time Frame from date of randomization until 3 years later at end of study
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population, primary population for efficacy analysis, includes all randomized patients.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description:
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Overall Number of Participants Analyzed 47 49
Median (Full Range)
Unit of Measure: days
134
(83 to 184)
40
(40 to 40)
8.Secondary Outcome
Title Percentage of Participants for Whom Disease Control Was Achieved
Hide Description Participants with disease control: those who have as best response complete response (CR), partial response (PR) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease) according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame from date of randomization to end of treatment plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population, primary population for efficacy analysis, includes all randomized patients.
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description:
"Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
"Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
Overall Number of Participants Analyzed 47 49
Measure Type: Number
Unit of Measure: Percentage of participants
63.8 30.6
Time Frame [Not Specified]
Adverse Event Reporting Description

The following abbreviations were used in the Adverse Event section:

  • Common toxicity criteria for adverse events (CTCAE)
  • Absolute neutrophil count (ANC)
  • Alanine aminotransferase (AST)
  • Gastrointestinal (GI)
  • Not otherwise specified (NOS)
  • International normalized ratio (INR)
  • Alanine aminotransferase (ALT)
 
Arm/Group Title Sorafenib + Doxorubicin Placebo + Doxorubicin
Hide Arm/Group Description "Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks) "Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)
All-Cause Mortality
Sorafenib + Doxorubicin Placebo + Doxorubicin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sorafenib + Doxorubicin Placebo + Doxorubicin
Affected / at Risk (%) Affected / at Risk (%)
Total   19/47 (40.43%)   20/48 (41.67%) 
Blood and lymphatic system disorders     
Neutrophils * 1  2/47 (4.26%)  0/48 (0.00%) 
Hemoglobin * 1  1/47 (2.13%)  1/48 (2.08%) 
Cardiac disorders     
Supraventricular Arrhythmia, Atrial Fibrillation * 1  1/47 (2.13%)  1/48 (2.08%) 
Supraventricular Arrhythmia, Sinus Tachycardia * 1  1/47 (2.13%)  0/48 (0.00%) 
Cardiac Ischemia/Infarction * 1  2/47 (4.26%)  0/48 (0.00%) 
Hypotension * 1  0/47 (0.00%)  1/48 (2.08%) 
Gastrointestinal disorders     
Dehydration * 1  2/47 (4.26%)  2/48 (4.17%) 
Diarrhea * 1  1/47 (2.13%)  2/48 (4.17%) 
Vomiting * 1  3/47 (6.38%)  0/48 (0.00%) 
Mucositis (Clinical Exam), Oral Cavity * 1  1/47 (2.13%)  1/48 (2.08%) 
Nausea * 1  2/47 (4.26%)  0/48 (0.00%) 
Constipation * 1  1/47 (2.13%)  0/48 (0.00%) 
Ileus * 1  1/47 (2.13%)  0/48 (0.00%) 
General disorders     
Death not associated with CTCAE term, Disease Progression NOS * 1  3/47 (6.38%)  10/48 (20.83%) 
Fever * 1  0/47 (0.00%)  1/48 (2.08%) 
Fatigue * 1  1/47 (2.13%)  0/48 (0.00%) 
Pain, Back * 1  2/47 (4.26%)  1/48 (2.08%) 
Pain, Abdomen NOS * 1  2/47 (4.26%)  1/48 (2.08%) 
Pain, Chest/Thorax NOS * 1  1/47 (2.13%)  0/48 (0.00%) 
Pain, Liver * 1  1/47 (2.13%)  0/48 (0.00%) 
Hepatobiliary disorders     
Liver Dysfunction * 1  1/47 (2.13%)  0/48 (0.00%) 
Hepathobilary - other * 1  0/47 (0.00%)  1/48 (2.08%) 
Infections and infestations     
Febrile Neutropenia * 1  1/47 (2.13%)  5/48 (10.42%) 
Infection with normal ANC, Skin (Cellulitis) * 1  2/47 (4.26%)  0/48 (0.00%) 
Infection (Documented Clinically), Blood * 1  1/47 (2.13%)  0/48 (0.00%) 
Infection (Documented Clinically), Kidney * 1  1/47 (2.13%)  0/48 (0.00%) 
Infection (Documented Clinically), Lung (Pneumonia) * 1  0/47 (0.00%)  1/48 (2.08%) 
Infection (Documented Clinically), Skin (Cellulitis) * 1  1/47 (2.13%)  0/48 (0.00%) 
Infection with normal ANC, Soft Tissue NOS * 1  0/47 (0.00%)  1/48 (2.08%) 
Metabolism and nutrition disorders     
Hyperkalemia * 1  2/47 (4.26%)  0/48 (0.00%) 
Lipase * 1  1/47 (2.13%)  1/48 (2.08%) 
Bilirubin (Hyperbilirubinemia) * 1  1/47 (2.13%)  0/48 (0.00%) 
Hypercalcemia * 1  1/47 (2.13%)  0/48 (0.00%) 
Nervous system disorders     
Neurology - other * 1  0/47 (0.00%)  1/48 (2.08%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea (Shortness of Breath) * 1  2/47 (4.26%)  1/48 (2.08%) 
Hiccoughs * 1  1/47 (2.13%)  0/48 (0.00%) 
Vascular disorders     
Hemorrhage, GI, Stomach * 1  1/47 (2.13%)  0/48 (0.00%) 
Hemorrhage, GI, Upper GI NOS * 1  1/47 (2.13%)  0/48 (0.00%) 
Thrombosis/Thrombus/Embolism * 1  1/47 (2.13%)  1/48 (2.08%) 
Artery Injury, Visceral * 1  1/47 (2.13%)  0/48 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTC V3
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sorafenib + Doxorubicin Placebo + Doxorubicin
Affected / at Risk (%) Affected / at Risk (%)
Total   47/47 (100.00%)   48/48 (100.00%) 
Blood and lymphatic system disorders     
Neutrophils * 1  31/47 (65.96%)  29/48 (60.42%) 
Hemoglobin * 1  15/47 (31.91%)  15/48 (31.25%) 
Leukocytes * 1  10/47 (21.28%)  9/48 (18.75%) 
Edema: Limb * 1  15/47 (31.91%)  14/48 (29.17%) 
Blood Other * 2  6/47 (12.77%)  7/48 (14.58%) 
Platelets * 2  7/47 (14.89%)  9/48 (18.75%) 
INR * 2  0/47 (0.00%)  3/48 (6.25%) 
Cardiac disorders     
Supraventricular Arrhythmia, Sinus Tachycardia * 2  4/47 (8.51%)  0/48 (0.00%) 
Hypertension * 2  8/47 (17.02%)  0/48 (0.00%) 
Hypotension * 2  0/47 (0.00%)  4/48 (8.33%) 
Left Ventricular Systolic Dysfunction * 2  9/47 (19.15%)  0/48 (0.00%) 
Eye disorders     
Ocular- Other * 2  4/47 (8.51%)  0/48 (0.00%) 
Watery Eye * 2  3/47 (6.38%)  0/48 (0.00%) 
Gastrointestinal disorders     
Nausea * 1  27/47 (57.45%)  27/48 (56.25%) 
Constipation * 1  21/47 (44.68%)  21/48 (43.75%) 
Anorexia * 1  24/47 (51.06%)  14/48 (29.17%) 
Diarrhea * 1  25/47 (53.19%)  12/48 (25.00%) 
Mucositis (Functional/Symptomatic), Oral Cavity * 1  11/47 (23.40%)  14/48 (29.17%) 
GI - other * 1  13/47 (27.66%)  7/48 (14.58%) 
Mucositis (Clinical Exam), Oral Cavity * 1  10/47 (21.28%)  6/48 (12.50%) 
Taste Alteration * 1  10/47 (21.28%)  5/48 (10.42%) 
Vomiting * 1  17/47 (36.17%)  10/48 (20.83%) 
Ascites * 2  4/47 (8.51%)  6/48 (12.50%) 
Distention * 2  5/47 (10.64%)  6/48 (12.50%) 
Dry Mouth * 2  4/47 (8.51%)  4/48 (8.33%) 
Dysphagia * 2  7/47 (14.89%)  0/48 (0.00%) 
Flatulence * 2  3/47 (6.38%)  4/48 (8.33%) 
Hemorrhoids * 2  0/47 (0.00%)  3/48 (6.25%) 
Heartburn * 2  5/47 (10.64%)  3/48 (6.25%) 
Teeth * 2  3/47 (6.38%)  0/48 (0.00%) 
Liver Dysfunction * 2  0/47 (0.00%)  3/48 (6.25%) 
General disorders     
Fatigue * 1  39/47 (82.98%)  32/48 (66.67%) 
Insomnia * 1  13/47 (27.66%)  8/48 (16.67%) 
Pain, Abdomen NOS * 1  18/47 (38.30%)  15/48 (31.25%) 
Pain, Back * 1  14/47 (29.79%)  7/48 (14.58%) 
Fever * 2  4/47 (8.51%)  4/48 (8.33%) 
Weight Loss * 2  9/47 (19.15%)  7/48 (14.58%) 
Constitutional Symptoms- Other * 2  7/47 (14.89%)  0/48 (0.00%) 
Rigors/Chills * 2  5/47 (10.64%)  0/48 (0.00%) 
Sweating * 2  3/47 (6.38%)  4/48 (8.33%) 
Pain, Chest Wall * 2  3/47 (6.38%)  3/48 (6.25%) 
Pain, Extremity-Limb * 2  3/47 (6.38%)  0/48 (0.00%) 
Pain, Head/Headache * 2  9/47 (19.15%)  6/48 (12.50%) 
Pain, Joint * 2  9/47 (19.15%)  3/48 (6.25%) 
Pain, Muscle * 2  6/47 (12.77%)  0/48 (0.00%) 
Pain, Other * 2  5/47 (10.64%)  3/48 (6.25%) 
Pain, Liver * 2  6/47 (12.77%)  3/48 (6.25%) 
Pain, Middle Ear * 2  3/47 (6.38%)  0/48 (0.00%) 
Pain, Pain NOS * 2  3/47 (6.38%)  0/48 (0.00%) 
Pain, Stomach * 2  3/47 (6.38%)  0/48 (0.00%) 
Pain, Throat/Pharynx/Larynx * 2  3/47 (6.38%)  0/48 (0.00%) 
Immune system disorders     
Rhinits * 2  4/47 (8.51%)  5/48 (10.42%) 
Infections and infestations     
Infection(Documented Clinically), Oral cavity - gums * 2  6/47 (12.77%)  3/48 (6.25%) 
Febrile Neutropenia * 2  0/47 (0.00%)  3/48 (6.25%) 
Infection- Other * 2  3/47 (6.38%)  3/48 (6.25%) 
Metabolism and nutrition disorders     
Bilirubin (Hyperbilirubinemia) * 1  15/47 (31.91%)  15/48 (31.25%) 
AST * 1  11/47 (23.40%)  7/48 (14.58%) 
Alkaline Phosphatase * 2  5/47 (10.64%)  7/48 (14.58%) 
ALT * 2  8/47 (17.02%)  4/48 (8.33%) 
Hypercalcemia * 2  0/47 (0.00%)  3/48 (6.25%) 
Hyperglycemia * 2  0/47 (0.00%)  3/48 (6.25%) 
Hypoalbuminemia * 2  3/47 (6.38%)  3/48 (6.25%) 
Hypophosphatemia * 2  0/47 (0.00%)  3/48 (6.25%) 
Hyperkalemia * 2  3/47 (6.38%)  0/48 (0.00%) 
Hypocalcemia * 2  3/47 (6.38%)  0/48 (0.00%) 
Metabolic/Lab- Other * 2  3/47 (6.38%)  5/48 (10.42%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal- Other * 2  8/47 (17.02%)  4/48 (8.33%) 
Nervous system disorders     
Dizziness * 1  10/47 (21.28%)  4/48 (8.33%) 
Mood Alteration, Anxiety * 2  3/47 (6.38%)  3/48 (6.25%) 
Mood Alteration, Depression * 2  4/47 (8.51%)  0/48 (0.00%) 
Neuropathy: sensory * 2  7/47 (14.89%)  4/48 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  13/47 (27.66%)  9/48 (18.75%) 
Hiccoughs * 2  3/47 (6.38%)  0/48 (0.00%) 
Nasal/Paranasal Reactions * 2  0/47 (0.00%)  4/48 (8.33%) 
Pulmonary- Other * 2  5/47 (10.64%)  3/48 (6.25%) 
Dyspnea(Shortness of Breath) * 2  8/47 (17.02%)  8/48 (16.67%) 
Voice Changes * 2  5/47 (10.64%)  0/48 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  24/47 (51.06%)  25/48 (52.08%) 
Rash/Desquamation * 1  18/47 (38.30%)  8/48 (16.67%) 
Hand-Foot Skin Reaction * 1  14/47 (29.79%)  0/48 (0.00%) 
Dry Skin * 1  10/47 (21.28%)  4/48 (8.33%) 
Acne * 2  3/47 (6.38%)  0/48 (0.00%) 
Bruising * 2  6/47 (12.77%)  3/48 (6.25%) 
Nail changes * 2  5/47 (10.64%)  0/48 (0.00%) 
Dermatology- Other * 2  8/47 (17.02%)  6/48 (12.50%) 
Pruritus * 2  9/47 (19.15%)  3/48 (6.25%) 
Flushing * 2  3/47 (6.38%)  0/48 (0.00%) 
Vascular disorders     
Hemorrhage, GI, Oral Cavity * 2  3/47 (6.38%)  0/48 (0.00%) 
Hemorrhage Pulmonary, Nose * 2  5/47 (10.64%)  3/48 (6.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTC V3
2
Term from vocabulary, NCI CTCAE v. 3.0
The study had been prematurely terminated by the sponsor because positive results were obtained in another Nexavar trial (Phase 3 study 100554 NCT00105443). NCI-CTC was translated to MedDRA for SOCs only.
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.
The institution of the Coordinating Investigator (CI) has the right, consistent with academic standards, to publish any proposed publication written by the consultant as part of their services under this agreement. If the sponsor believes that any proposed publication contained any confidential information, the sponsor shall notify the CI, and the CI shall remove such confidential information.
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: NCT00108953    
Other Study ID Numbers: 11546
2004-001770-40 ( EudraCT Number )
First Submitted: April 21, 2005
First Posted: April 22, 2005
Results First Submitted: April 23, 2009
Results First Posted: June 11, 2009
Last Update Posted: October 31, 2014