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Nexavar (Sorafenib) - Summary

 
 



NEXAVAR 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 >>

NEWS HIGHLIGHTS

Media Articles Related to Nexavar (Sorafenib)

Clinical Focus in Renal Cell Carcinoma: Indolent Disease Tx
Source: MedPage Today Oncology/Hematology [2014.11.19]
(MedPage Today) -- Initial observation and intermittent therapy might be options for selected patients.

Clinical Focus In Renal Cell Carcinoma: Clues from Gene Studies
Source: MedPage Today Oncology/Hematology [2014.11.17]
(MedPage Today) -- Mutations in four genes appear to play a key role in the origin of renal cell carcinoma.

more news >>

Published Studies Related to Nexavar (Sorafenib)

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

Field-practice study of sorafenib therapy for hepatocellular carcinoma: A prospective multicenter study in Italy. [2011.12]
A multicenter randomized controlled trial established sorafenib as a standard of care for patients with advanced hepatocellular carcinoma (HCC). Because the study was prematurely interrupted due to survival benefits in the sorafenib arm, we conducted an observational study to adequately assess risks and benefits of this regimen in field practice...

Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer. [2011.08.11]
BACKGROUND: The incidence of thyroid cancer and the number of patients who die from this disease are increasing globally... DISCUSSION: The DECISION study has been designed to test whether sorafenib improves PFS in patients with locally advanced or metastatic RAI-refractory DTC.

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

cancer

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

level

- 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: 2014-11-19

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