Neoplasms

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Digestive System Diseases

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Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

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Adenocarcinoma

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Digestive System Neoplasms

Gastrointestinal Diseases

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Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Sorafenib (Nexavar, BAY43-9006)

Bayer Study Director

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:

* Pharmacokinetics (PK) profile of Sorafenib
* Plasma and tissue tumor biomarkers

A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

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.

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.

Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).

Time from the first date of receiving study drug until the first documented PD.

Time from the first day of receiving study drug until there was a documented PD or response.

Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = \>25% regression.

Time from the date that MR was first documented to the date that PD was first documented.

Time from the first date of receiving study medication to death.

Bayer

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)

Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d."Other AE" section includes SAEs

Sorafenib 400 mg b.i.d.

Age, Categorical

Sex: Female, Male

Status A

Status B

Missing

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.

Child Pugh Status

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

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.

Eastern Cooperative Group performance status (ECOG PS) at study entry

Stage 1

Stage 2

Stage 3

Stage 4

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.

Stage of Disease at study entry (TNM Classification)

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.

Therapeutic Area Head

Complete response (CR)

Partial response (PR)

Minor response (MR)

Stable disease (SD)

Progressive disease (PD)

Not available for independent review (NA)

Not evaluable (NE)

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.

Percentage of Participants for Each Type of Response

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.

Duration of 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).

Spots Global Cancer Trial Database for A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

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