Clinical studies on Sorafenib tosylate

Sorafenib tosylate is a white to yellowish or brownish solid with a molecular formula of C21H16ClF3N4O3 x C7H8O3S and a molecular weight of 637.0 g/mole. It is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400. The CAS NO is 475207-59-1.

Each red, round NEXAVAR film-coated tablet contains sorafenib tosylate (274 mg) equivalent to 200 mg of sorafenib and the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium lauryl sulphate, magnesium stearate, polyethylene glycol, titanium dioxide and ferric oxide red.

This article we will talk about the Clinical studies on Sorafenib tosylate from 5 aspects.

For Lung
In some kinds of lung cancer, Sorafenib tosylate(CAS NO:475207-59-1) administered in addition to paclitaxel and carboplatin may be detrimental to patients.

For Liver
At ASCO 2007, results from the SHARP trial were presented, which showed efficacy of Sorafenib tosylate in hepatocellular carcinoma. The primary endpoint was median overall survival, which showed a 44% improvement in patients who received sorafenib compared to placebo. 

Both median survival and time to progression showed 3-month improvements. There was no difference in quality of life measures, possibly attributable to toxicity of Sorafenib tosylate or symptoms related to underlying progression of liver disease. Of note, this trial only included patients with Child-Pugh Class A (i.e. mildest) cirrhosis. The results of the study appear in the July 24, 2008, edition of The New England Journal of Medicine. Because of this trial Sorafenib obtained FDA approval for the treatment of advanced hepatocellular carcinoma in November 2007.

In a randomized, double-blind, phase II trial combining sorafenib with doxorubicin, the median time to progression was not significantly delayed compared with doxorubicin alone in patients with advanced hepatocellular carcinoma. Median durations of overall survival and progression-free survival were significantly longer in patients receiving Sorafenib tosylate plus doxorubicin than in those receiving doxorubicin alone.

A prospective single-center phase II study which included the patients with unresectable hepatocellular carcinoma (HCC)concluding that the combination of Sorafenib tosylate and DEB-TACE in patients with unresectable HCC is well tolerated and safe, with most toxicities related to sorafenib.

For Thyroid
A phase 3 clinical trial has started recruiting to use sorafenib for non-responsive thyroid cancer.

For Kidney
An article in The New England Journal of Medicine, published January 2007, showed compared with placebo, treatment with Sorafenib tosylate prolongs progression-free survival in patients with advanced clear cell renal cell carcinoma in whom previous therapy has failed. The median progression-free survival was 5.5 months in the Sorafenib tosylate group and 2.8 months in the placebo group. A few reports described patients with stage IV renal cell carcinomas that were successfully treated with a multimodal approach including neurosurgical, radiation, and Sorafenib tosylate.

For Brain
There is a phase I/II study at the Mayo Clinic of Sorafenib tosylate and temsirolimus for recurrent glioblastoma.

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