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Nexavar (Sorafenib) - Summary

 
 



NEXAVAR SUMMARY

NEXAVAR, a multikinase inhibitor targeting several serine/threonine and receptor tyrosine kinases, is the tosylate salt of sorafenib.

NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma.


See all Nexavar indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Nexavar (Sorafenib)

Argos Therapeutics announces pilot clinical trial of AGS-003 as neoadjuvant immunotherapy for localized renal cell carcinoma
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.08.11]
Argos Therapeutics Inc., an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies for the treatment of cancer based on the Arcelis®...

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Published Studies Related to Nexavar (Sorafenib)

Sorafenib or placebo with either gemcitabine or capecitabine in patients with HER-2-negative advanced breast cancer that progressed during or after bevacizumab. [2013]
CONCLUSION: The addition of sorafenib to gemcitabine/capecitabine provided a

Phase III trial of carboplatin and paclitaxel with or without sorafenib in metastatic melanoma. [2013]
metastatic melanoma... CONCLUSION: Sorafenib does not improve OS when given in combination with CP for

AMG 386 in combination with sorafenib in patients with metastatic clear cell carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2 study. [2012]
study... CONCLUSIONS: In patients with mRCC, AMG 386 plus sorafenib was tolerable but did

Sorafenib in locally advanced or metastatic breast cancer. [2012]
INTRODUCTION: Sorafenib is an oral multikinase inhibitor with anti-angiogenic and anti-proliferative activity that is indicated for use in hepatocellular and renal cell carcinomas.The variability in results across studies with sorafenib may be related to the chemotherapy combination and/or patient population.

Transarterial chemoembolization plus sorafenib: a sequential therapeutic scheme for HCV-related intermediate-stage hepatocellular carcinoma: a randomized clinical trial. [2012]
CONCLUSION: A conventional TACE procedure followed by sorafenib treatment

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Clinical Trials Related to Nexavar (Sorafenib)

Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC) [Completed]
This is a phase 1b, open-Label study of sorafenib with BIIB022 in subjects with advanced hepatocellular carcinoma.

Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia [Not yet recruiting]
There are 2 parts to this study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerated dose of the combination of selinexor (KPT-330) and sorafenib (Nexavar) that can be given to patients with FLT3-ITD mutated AML or FLT3-mutated high-risk MDS. The goal of Part 2 of this study is to learn if the dose found in Part 1 can help to control the disease. The safety of the drug combination will also be studied in both parts of this study.

Nexavar Post-marketing Surveillance for Renal Cell Carcinoma in Japan [Completed]
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). 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 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.

Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program [Completed]
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.

Nexavar Post-marketing Surveillance for Hepatocellular Carcinoma in Japan [Completed]
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.

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Reports of Suspected Nexavar (Sorafenib) Side Effects

Diarrhoea (345)Palmar-Plantar Erythrodysaesthesia Syndrome (282)Fatigue (194)Decreased Appetite (188)Nausea (171)Hepatic Neoplasm Malignant (164)Pyrexia (143)Rash (134)Hypertension (132)Ascites (126)more >>


Page last updated: 2015-08-11

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