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Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib 400 mg b.i.d. | Experimental | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants for Each Type of Response | Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria. | Until 30 days after termination of active therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion. | up to 3 years later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90057 | 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. | |
| 21673874 | Result |
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Of 147 enrolled patients, 137 received treatment. 10 patients failed screening; reasons were: target lesions identified at baseline (3), liver function tests too high for inclusion (2), prior systemic anticancer treatment (2), creatinine too high for inclusion (1), platelets too low for inclusion (1), diagnosis of HCC not confirmed (1)
Only subjects with measurable, histologically or cytologically documented hepatocellur carcinoma (HCC) which was inoperable or who had refused surgery could participate in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib 400 mg b.i.d. | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
Not provided
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| Time to Response | Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation). | up to 3 years later |
| Time to Progression | Time from the first date of receiving study drug until the first documented PD. | up to 3 years later |
| Duration of Stable Disease | Time from the first day of receiving study drug until there was a documented PD or response. | up to 3 years later |
| Time to Minor Response | Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression. | up to 3 years later |
| Duration of Minor Response | Time from the date that MR was first documented to the date that PD was first documented. | Time from MR to PD |
| Overall Survival | Time from the first date of receiving study medication to death. | Start of treatment to death |
| New York |
| New York |
| 10021-6007 |
| United States |
| Bruxelles - Brussel | 1000 | Belgium |
| Bruxelles - Brussel | 1070 | Belgium |
| Bruxelles - Brussel | 1090 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Lille | 59020 | France |
| Marseille | 13005 | France |
| Paris | 75020 | France |
| Rennes | 35062 | France |
| Saint-Herblain | 44805 | France |
| Haifa | Israel | 31096 | Israel |
| Jerusalem | Israel | 91120 | Israel |
| Petah Tikva | Israel | 49100 | Israel |
| Rehovot | Israel | 76100 | Israel |
| Tel Aviv | Israel | 64239 | Israel |
| Tel Litwinsky | 52621 | Israel |
| Rozzano | Milano | 20089 | Italy |
| Forlì | 47100 | Italy |
| Milan | 20122 | Italy |
| Pisa | 56126 | Italy |
| Verona | 37126 | Italy |
| Abou-Alfa GK, Amadori D, Santoro A, Figer A, De Greve J, Lathia C, Voliotis D, Anderson S, Moscovici M, Ricci S. Safety and Efficacy of Sorafenib in Patients with Hepatocellular Carcinoma (HCC) and Child-Pugh A versus B Cirrhosis. Gastrointest Cancer Res. 2011 Mar;4(2):40-4. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Follow Up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib 400 mg b.i.d. | Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Child Pugh Status | A Child-Pugh (CP) score (determined by encephalopathy grade, ascites, serum bilirubin and albumin, prothrombin time) is used to assess the prognosis of chronic liver disease, mainly cirrhosis. One of the inclusion criterion for this study was a CP class A (good operative risk) or B (moderate risk) score; class C (poor operative risk) was excluded. | Number | participants |
| ||||||||||||||||||||||
| Eastern Cooperative Group performance status (ECOG PS) at study entry | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. 0 = fully active, 1 = restricted strenuous activity, 2 = ambulatory, 3 = limited selfcare, 4 = completely disabled, 5 = dead. Subjects entering this study must have had an ECOG score of 0 or 1. | Number | participants |
| ||||||||||||||||||||||
| Stage of Disease at study entry (TNM Classification) | TNM (Tumor, Nodes, Metastasis) is a solid tumor classification system. T1-T4 = size and degree of spreading. N0-N3 = degree of spreading into lymph nodes. M0-M1 = whether the cancer has metastazied beyond the lymph nodes or not. Bigger numbers are worse. One of the inclusion criteria for this study was inoperable tumor T2-T4, any N, M0 or M1. | 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 | Percentage of Participants for Each Type of Response | Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria. | Intention to Treat (ITT) analyses were performed on subgroups of patients categorized by baseline characteristics of ECOG Performance Status, Child Pugh status, TNM stage at study entry, prior surgical procedure, hepatitis A and B status, and age. | Posted | Number | percentage of participants | Until 30 days after termination of active therapy |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion. | Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and C status (positive vs negative). The 3 subjects are censored at time of evaluation. The Median is not estimable so the reported number is biased. | Posted | Median | Full Range | days | up to 3 years later |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response | Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation). | Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). | Posted | Median | 95% Confidence Interval | days | up to 3 years later |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression | Time from the first date of receiving study drug until the first documented PD. | Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). | Posted | Median | 95% Confidence Interval | days | up to 3 years later |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Stable Disease | Time from the first day of receiving study drug until there was a documented PD or response. | Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). | Posted | Median | 95% Confidence Interval | days | up to 3 years later |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Minor Response | Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression. | Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). | Posted | Median | 95% Confidence Interval | days | up to 3 years later |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Minor Response | Time from the date that MR was first documented to the date that PD was first documented. | Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). | Posted | Mean | Full Range | days | Time from MR to PD |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from the first date of receiving study medication to death. | Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative). | Posted | Median | 95% Confidence Interval | days | Start of treatment to death |
|
|
Not provided
Acronyms in Adverse Event section: Gastrointestinal (GI), Central Nervous System (CNS), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma Glutamyl Transpeptidase (GGT), Acute Respiratory Distress Syndrome (ARDS), Without grade 3 or 4 (W/O GR 3 or 4), Neutropenia (Neu)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sorafenib 400 mg b.i.d. | Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d."Other AE" section includes SAEs | 77 | 137 | 126 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Supraventricular Arrythmia, Sinus Bradicardia | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Supraventricular Arrythmia, Supraventricular Tachycardia | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Cardiac Ischemia / Infarction | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Cardiac General - Other (Specify) | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Constitutional Symptoms - Other (Specify) | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| GI - Other (Specify) | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hypercreatininemia | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Genito-Urinary - Other | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| CNS Hemorrhage | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Melena / GI Bleeding | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Epistaxis | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hemorrhage with Surgery | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hemorrhage - Other (Specify) | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Rectal Bleeding | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hematuria | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hematemesis | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hemorrhage / Bleeding W/O GR 3 or GR 4 Thrombo | Vascular disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Alkaline Phospharase | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| AST | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Liver Dysfunction | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| GGT increase | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hepatobiliary - Other (Specify) | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Infection W/GR 3 or GR 4 Neu | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Infection without Neutropenia | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Infection - Other (Specify) | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Lymphatics - Other (Specify) | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Musculoskeletal - Other (Specify) | Musculoskeletal and connective tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| CNS Ischemia | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Confusion | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Neurology - Other (Specify) | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Syncope (Fainting) | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pain, Abdomen NOS | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pain - Other (Specify) | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| ARDS | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pulmonary - Other (Specify) | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Dyspnea (Shortness of Breath) | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Head-Foot Skin Reaction | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Wound Complication, non-infectious | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Dermatology - Other (Specify) | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Rash/Desquamation | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| AST | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Bilirubin (Hyperbilirubinemia) | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pain, Abdomen NOS | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pain, Other | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hand-Foot Skin Reaction | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Rash/Desquamation | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Edema | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Weight Loss | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| GI-Other | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Alkaline Phosphatase | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| ALT | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| GGT | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hepatobiliary-Other | Hepatobiliary disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Infection Without Neutropenia | Infections and infestations | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Metabolic/Lab-Other | Metabolism and nutrition disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pain, Head/Headache | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pain, Muscle | General disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pulmonary-Other | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Dyspnea (Shortness of Breath) | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Voice Changes | Respiratory, thoracic and mediastinal disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Dermatology-Other | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | NCI CTC 2.0 | Non-systematic Assessment |
|
Subjects had advanced disease and were heavily pretreated. National Cancer Institute-Common Toxicity Criteria (NCI-CTC) was translated to Medical Dictionary for Regulatory Activities (MedDRA) for System Organ Class (SOC) only.
Agreement between Sponsor and PI should be reached before publication
| 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 |
| 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 |
Not provided
Not provided
| Missing |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
|
| Stage 3 |
|
| Stage 4 |
|
| Title | Measurements |
|---|---|
|
| Stable disease (SD) |
|
| Progressive disease (PD) |
|
| Not available for independent review (NA) |
|
| Not evaluable (NE) |
|
|
|
|
|
|
|
|