Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001770-40 | EudraCT Number |
Not provided
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The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).
In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (TTP), time to symptomatic progression (TTSP), response rate (RR) and overall survival between the 2 study populations.
The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.
The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib + Doxorubicin | Experimental | "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 | Active Comparator | "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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin | Drug | Multi kinase inhibitor plus Chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | TTP was defined as the time from randomization to radiological disease progression by independent assessment. | from date of randomization of the first patient until 3 years later |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The time from date of randomization to date of death | from date of randomization of the first patient until 3 years later |
| Progression Free Survival (PFS) | 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 |
Not provided
Inclusion Criteria:
Patients who have a life expectancy of at least 12 weeks
Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
Patients must have at least one tumor lesion that meets both of the following criteria:
Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16908937 | Result | Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14. | |
| 21081728 | Result |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
Not provided
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.
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.)
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib + Doxorubicin | "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) |
| FG001 | Placebo + Doxorubicin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
Not provided
Not provided
Not provided
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| Doxorubicin/Placebo | Drug | Chemotherapy plus Placebo |
|
| from date of randomization of the first patient until 3 years later |
| Percentage of Participants in Each Category of Best Tumor Response | 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. | achieved during treatment or within 30 days after termination of active therapy |
| Time to Symptomatic Progression (TTSP) | 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 | from date of randomization of the first patient until 3 years later |
| Duration of Response | 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 | from date of randomization of the first patient until 3 years later |
| Time to Response (TTR) | 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 | from date of randomization until 3 years later at end of study |
| Percentage of Participants for Whom Disease Control Was Achieved | 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) | from date of randomization to end of treatment plus 30 days |
| Beverly Hills |
| California |
| 90211-1850 |
| United States |
| Orange | California | 92668-3298 | United States |
| Palo Alto | California | 94304-1207 | United States |
| San Francisco | California | 94115 | United States |
| San Francisco | California | 94121 | United States |
| Sylmar | California | 91342 | United States |
| Miami | Florida | 33136 | United States |
| Lafayette | Louisiana | 70506 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Hackensack | New Jersey | 07601 | United States |
| New York | New York | 10065 | United States |
| Rochester | New York | 14642 | United States |
| Nashville | Tennessee | 37203 | United States |
| Seattle | Washington | 98101 | United States |
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1264AAA | Argentina |
| Neuquén | Neuquén Province | Q8300HDH | Argentina |
| Buenos Aires | Argentina |
| Toronto | Ontario | M5G 2M9 | Canada |
| Hong Kong | Hong Kong | Hong Kong |
| Kazan' | 420111 | Russia |
| Kirov | 610002 | Russia |
| Krasnodar | 350040 | Russia |
| Maidstone | Kent | ME16 9QQ | United Kingdom |
| London | London | W12 0HS | United Kingdom |
| Manchester | Manchester | M20 4BX | United Kingdom |
| Bebington | Merseyside | CH63 4JY | United Kingdom |
| Birmingham | West Midlands | B15 2TT | United Kingdom |
| Abou-Alfa GK, Johnson P, Knox JJ, Capanu M, Davidenko I, Lacava J, Leung T, Gansukh B, Saltz LB. Doxorubicin plus sorafenib vs doxorubicin alone in patients with advanced hepatocellular carcinoma: a randomized trial. JAMA. 2010 Nov 17;304(19):2154-60. doi: 10.1001/jama.2010.1672. |
"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) |
| COMPLETED |
|
| NOT COMPLETED |
|
| Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib + Doxorubicin | "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) |
| BG001 | Placebo + Doxorubicin | "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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Child Pugh Status | 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. | Number | participants |
| |||||||||||||||
| Eastern Cooperative Group performance status (ECOG PS) at study entry | 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. | Number | participants |
| |||||||||||||||
| Tumor burden: Extrahepatic spread | Tumor spread outside the liver, which describes an aggressive and advanced tumor pattern. | Number | participants |
| |||||||||||||||
| Tumor burden: Macroscopic vascular invasion | Tumor spread into the blood vessels as determined through radiological assessment (e.g., x-ray, imaging), which describes an aggressive and advanced tumor pattern. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Progression (TTP) | TTP was defined as the time from randomization to radiological disease progression by independent assessment. | The intent-to-treat (ITT) population, primary population for efficacy analysis, includes all randomized patients. | Posted | Median | 95% Confidence Interval | days | from date of randomization of the first patient until 3 years later |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The time from date of randomization to date of death | 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. | Posted | Median | 95% Confidence Interval | days | from date of randomization of the first patient until 3 years later |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | 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 | The ITT population, primary population for efficacy analysis, includes all randomized patients. | Posted | Median | 95% Confidence Interval | days | from date of randomization of the first patient until 3 years later |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Each Category of Best Tumor Response | 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. | The ITT population, primary population for efficacy analysis, includes all randomized patients. | Posted | Number | Percentage of participants | achieved during treatment or within 30 days after termination of active therapy |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Symptomatic Progression (TTSP) | 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 | The ITT population, primary population for efficacy analysis, includes all randomized patients. | Posted | Median | 95% Confidence Interval | days | from date of randomization of the first patient until 3 years later |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | 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 | The ITT population, primary population for efficacy analysis, includes all randomized patients. | Posted | Median | Full Range | days | from date of randomization of the first patient until 3 years later |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | 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 | The ITT population, primary population for efficacy analysis, includes all randomized patients. | Posted | Median | Full Range | days | from date of randomization until 3 years later at end of study |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants for Whom Disease Control Was Achieved | 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) | The ITT population, primary population for efficacy analysis, includes all randomized patients. | Posted | Number | Percentage of participants | from date of randomization to end of treatment plus 30 days |
|
|
Not provided
The following abbreviations were used in the Adverse Event section:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sorafenib + Doxorubicin | "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) | 19 | 47 | 47 | 47 | ||
| EG001 | Placebo + Doxorubicin | "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) | 20 | 48 | 48 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Supraventricular Arrhythmia, Atrial Fibrillation | Cardiac disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Supraventricular Arrhythmia, Sinus Tachycardia | Cardiac disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Cardiac Ischemia/Infarction | Cardiac disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Death not associated with CTCAE term, Disease Progression NOS | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Mucositis (Clinical Exam), Oral Cavity | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hemorrhage, GI, Stomach | Vascular disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hemorrhage, GI, Upper GI NOS | Vascular disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Liver Dysfunction | Hepatobiliary disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hepathobilary - other | Hepatobiliary disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | NCI CTC V3 | Non-systematic Assessment |
| |
| Infection with normal ANC, Skin (Cellulitis) | Infections and infestations | NCI CTC V3 | Non-systematic Assessment |
| |
| Infection (Documented Clinically), Blood | Infections and infestations | NCI CTC V3 | Non-systematic Assessment |
| |
| Infection (Documented Clinically), Kidney | Infections and infestations | NCI CTC V3 | Non-systematic Assessment |
| |
| Infection (Documented Clinically), Lung (Pneumonia) | Infections and infestations | NCI CTC V3 | Non-systematic Assessment |
| |
| Infection (Documented Clinically), Skin (Cellulitis) | Infections and infestations | NCI CTC V3 | Non-systematic Assessment |
| |
| Infection with normal ANC, Soft Tissue NOS | Infections and infestations | NCI CTC V3 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Bilirubin (Hyperbilirubinemia) | Metabolism and nutrition disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Neurology - other | Nervous system disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Pain, Back | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Pain, Abdomen NOS | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Pain, Chest/Thorax NOS | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Pain, Liver | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Dyspnea (Shortness of Breath) | Respiratory, thoracic and mediastinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Thrombosis/Thrombus/Embolism | Vascular disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Artery Injury, Visceral | Vascular disorders | NCI CTC V3 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Insomnia | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Mucositis (Functional/Symptomatic), Oral Cavity | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| GI - other | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Mucositis (Clinical Exam), Oral Cavity | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Taste Alteration | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Edema: Limb | Blood and lymphatic system disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Bilirubin (Hyperbilirubinemia) | Metabolism and nutrition disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| AST | Metabolism and nutrition disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Pain, Abdomen NOS | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Pain, Back | General disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Rash/Desquamation | Skin and subcutaneous tissue disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Hand-Foot Skin Reaction | Skin and subcutaneous tissue disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC V3 | Non-systematic Assessment |
| |
| Rhinits | Immune system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Blood Other | Blood and lymphatic system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| INR | Blood and lymphatic system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Supraventricular Arrhythmia, Sinus Tachycardia | Cardiac disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Left Ventricular Systolic Dysfunction | Cardiac disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Weight Loss | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Constitutional Symptoms- Other | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Rigors/Chills | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Sweating | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Distention | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Teeth | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hemorrhage, GI, Oral Cavity | Vascular disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hemorrhage Pulmonary, Nose | Vascular disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Liver Dysfunction | Gastrointestinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Infection(Documented Clinically), Oral cavity - gums | Infections and infestations | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Infections and infestations | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Infection- Other | Infections and infestations | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Musculoskeletal- Other | Musculoskeletal and connective tissue disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Alkaline Phosphatase | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Metabolic/Lab- Other | Metabolism and nutrition disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Mood Alteration, Anxiety | Nervous system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Mood Alteration, Depression | Nervous system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Ocular- Other | Eye disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Watery Eye | Eye disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Chest Wall | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Extremity-Limb | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Head/Headache | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Joint | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Muscle | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Other | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Liver | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Middle Ear | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Pain NOS | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Stomach | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pain, Throat/Pharynx/Larynx | General disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Hiccoughs | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Nasal/Paranasal Reactions | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pulmonary- Other | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Dyspnea(Shortness of Breath) | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Voice Changes | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Bruising | Skin and subcutaneous tissue disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Dermatology- Other | Skin and subcutaneous tissue disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | NCI CTCAE v. 3.0 | Non-systematic Assessment |
|
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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Study terminated by sponsor |
|
| Male |
|
| 6 (Child-Pugh A) |
|
| 7 (Child-Pugh B) |
|
| >7 |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| missing |
|
| no |
|
| no |
|
| missing |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|