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Sorafenib (BAY 43-9006): review of clinical development

Raymond Ng1, Eric X Chen

  • 1Department of Medical Oncology and Hematology, Princess Margaret Hospital and Faculty of Medicine, University of Toronto, Toronto, Canada.

Current Clinical Pharmacology
|August 1, 2008
PubMed

Insights

Sorafenib is a novel oral cancer drug that inhibits tumor cell proliferation and blood vessel growth. Phase I studies show it is well-tolerated and effective against kidney and liver cancers.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Sorafenib (BAY 43-9006) is an oral bis-aryl urea compound.
  • It functions as a RAF kinase inhibitor with anti-proliferative properties.
  • It also inhibits receptor tyrosine kinases (RTKs) involved in angiogenesis, including VEGFRs, Flt-3, and PDGFR-beta.

Purpose of the Study:

  • To evaluate the anti-proliferative and anti-angiogenic properties of sorafenib.
  • To determine the safety and tolerability of sorafenib in cancer patients.
  • To assess the anti-tumor activity of sorafenib in various cancer types.

Main Methods:

  • Phase I clinical studies were conducted to assess safety, tolerability, and recommended dosage.
  • Recommended Phase II dose established at 400 mg twice daily continuously.
  • Anti-tumor activity was evaluated in patients with different tumor types.

Main Results:

  • Sorafenib demonstrated good tolerability in Phase I trials.
  • Common toxicities included skin and gastrointestinal issues, and fatigue.
  • Observed anti-tumor activity in renal cell carcinoma and hepatocellular carcinoma.

Conclusions:

  • Sorafenib's dual anti-proliferative and anti-angiogenic mechanisms make it a promising cancer therapeutic.
  • Phase III randomized trials are underway for renal cell and hepatocellular carcinoma.
  • Results from ongoing Phase III studies are anticipated to further define sorafenib's role in cancer treatment.

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