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Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan

2014-09-30 16:38:23 | BioPortfolio

Summary

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Nexavar for unresectable hepatocellular carcinoma (HCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 2 or 3 months (dependent on sites) for Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be recruited and followed one year since starting Nexavar administration.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Carcinoma, Hepatocellular

Intervention

Sorafenib (Nexavar, BAY43-9006)

Location

Many locations
Japan

Status

Active, not recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-30T16:38:23-0400

Clinical Trials [1412 Associated Clinical Trials listed on BioPortfolio]

Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma

This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once d...

Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC)

To determine the tolerability, maximum tolerated dose, and pharmacokinetics of this drug.

A Study to Estimate Safety and Efficacy of Sorafenib (Bay 43-9006) in the Treatment of Hepatocellular Carcinoma

Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinom...

Sorafenib Gastric Cancer Asian Phase I Study

This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable / recurrent g...

Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer

The purpose of the study is to: - Find out if BAY 43-9006 prevents the growth of tumors - For patients who have stable cancer status after 3 months of treatment if it is safer ...

PubMed Articles [3269 Associated PubMed Articles listed on BioPortfolio]

The Outcome of Sorafenib Therapy on Unresectable Hepatocellular Carcinoma: Experience of Conversion and Salvage Hepatectomy.

We report the outcomes of sorafenib therapy for advanced hepatocellular carcinoma (HCC) in our Department.

Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial.

Sorafenib is the recommended treatment for patients with advanced hepatocellular carcinoma. We aimed to compare the efficacy and safety of sorafenib to that of selective internal radiotherapy (SIRT) w...

Glutamine synthetase mediates sorafenib sensitivity in β-catenin-active hepatocellular carcinoma cells.

The gene encoding β-catenin is frequently mutated in hepatocellular carcinoma cells. While the oncogenicity of β-catenin has been extensively studied, β-catenin's role in hepatocellular carcinoma t...

Complete response under sorafenib in patients with hepatocellular carcinoma. Relationship with dermatologic adverse events.

Background-aims: The clinical benefit of sorafenib in patients with hepatocellular carcinoma (HCC) has been undervalued due to the absence of complete responses even though patients who develop early ...

Sorafenib combined with radiofrequency ablation as treatment for patients with hepatocellular carcinoma: a systematic review and meta-analysis.

To evaluate the safety and efficacy of a combination of sorafenib and radiofrequency ablation (RFA) in patients with hepatocellular carcinoma (HCC).

Medical and Biotech [MESH] Definitions

An ORTHOHEPADNAVIRUS causing chronic liver disease and hepatocellular carcinoma in woodchucks. It closely resembles the human hepatitis B virus.

The type species of the genus ORTHOHEPADNAVIRUS which causes human HEPATITIS B and is also apparently a causal agent in human HEPATOCELLULAR CARCINOMA. The Dane particle is an intact hepatitis virion, named after its discoverer. Non-infectious spherical and tubular particles are also seen in the serum.

The first alpha-globulins to appear in mammalian sera during development of the embryo and the dominant serum proteins in early embryonic life. They reappear in the adult serum during certain pathologic states, primarily hepatocellular carcinoma. They may also be elevated in the amniotic fluid and maternal serum during pregnancy in ANENCEPHALY.

A primary malignant neoplasm of epithelial liver cells. It ranges from a well-differentiated tumor with EPITHELIAL CELLS indistinguishable from normal HEPATOCYTES to a poorly differentiated neoplasm. The cells may be uniform or markedly pleomorphic, or form GIANT CELLS. Several classification schemes have been suggested.

The founding member of the EPH FAMILY RECEPTORS. It was first cloned from an erythropoietin-producing human hepatocellular carcinoma cell line and is highly conserved among many mammalian species. Overproduction of the EphA1 receptor is associated with tumors and tumor cells of epithelial origin. It is also expressed at high levels in LIVER; LUNG; and KIDNEY; which is in contrast to many other members of the Eph receptor that are found primarily in tissues of the nervous system.

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