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Nexavar (Sorafenib) - Summary



Pregnancy Category D

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 >>


Media Articles Related to Nexavar (Sorafenib)

New surgical technique preserves kidney function following tumour removal
Source: Urology / Nephrology News From Medical News Today [2015.07.13]
Renal cell carcinomas are one of the most common types of cancer. In order to preserve its wide range of functions, every effort is made not to remove the entire kidney, but rather just a portion...

more news >>

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

more studies >>

Clinical Trials Related to Nexavar (Sorafenib)

Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv.) Renal Cell Carcinoma (RCC) [Completed]
The ROSORC trial is a randomized study comparing the efficacy of a new association (sorafenib and IL-2) versus the standard therapy (sorafenib) in patients affected by different histotypes of metastatic RCC. This study is a first line therapy for the advanced disease. The primary objective is the progression free survival (PFS) in the 2 arms of therapy and the secondary objective is the overall survival (OS) and the response rate (RR) and the safety profile of the combination comparing to sorafenib alone.

BAY 43-9006 (Sorafenib) Versus Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma [Active, not recruiting]
The purpose of the study is to:

- Find out if patients receiving BAY 43-9006 will live longer without tumor progression

than those receiving standard therapy with interferon alpha-2a

- Find out if a higher dose of BAY 43-9006 can inhibit tumor progression in patients who

progressed during standard dose treatment with BAY 43-9006, and for how long these patients live without progression

- Find out how long patients live without progression who receive BAY 43-9006 after

failing to respond to standard therapy with interferon alpha-2a

- Find out in how many percent of patients BAY 43-9006 prevents the growth of or shrinks

kidney tumors and/or their metastases depending on treatment and dosage

- Find out if BAY 43-9006 has any effect on the quality of life of patients with kidney


- Find out the level of BAY 43-9006 in the blood once per month and any changes in this


- Find out whether Bay 43-9006 effects are associated with specific biomarkers

Sorafenib in Resected Non-Small Cell Lung Carcinoma [Active, not recruiting]
This is an open-label, single-armed, multicentric, phase II study of Sorafenib treatment following surgery for NSCLC.

The primary hypothesis is to increase the progression-free survival (PFS) of the experimental group in comparison to a historical control group. For sample size calculation a 2 year PFS of 50% was calculated for the historical control group, and a 2 year PFS of 67% was estimated for the intervention group. These estimates are based on the actual PFS and overall survival (OS) of a defined population of 120 NSCLC patients treated at a single institution with surgery alone or surgery followed by adjuvant radiotherapy, which compares favorably to published international results, and the improvement of PFS achieved by 4 cycles of cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.

Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN) [Not yet recruiting]

Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib [Recruiting]
This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

more trials >>

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: 2015-07-13

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