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Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced,

A Awada1, A Hendlisz, T Gil

  • 1Jules Bordet Institute, Brussels, Belgium. ahmad.awada@bordet.be

British Journal of Cancer
|May 5, 2005
PubMed

Insights

This Phase I study found that oral BAY 43-9006, a dual Raf kinase and VEGFR inhibitor, is safe and well-tolerated in patients with advanced solid tumors. The drug demonstrated antitumour activity, with a maximum tolerated dose of 400 mg twice daily.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • BAY 43-9006 is a novel dual-action inhibitor targeting Raf kinase and vascular endothelial growth factor receptor (VEGFR).
  • It aims to inhibit tumor cell proliferation and angiogenesis.
  • This study focuses on its initial safety and efficacy evaluation in cancer patients.

Purpose of the Study:

  • Determine the safety profile and maximum tolerated dose (MTD) of oral BAY 43-9006.
  • Evaluate dose-limiting toxicities (DLTs), pharmacokinetics, and tumor response.
  • Assess the drug's tolerability in patients with advanced, refractory solid tumors.

Main Methods:

  • Phase I clinical trial design.
  • Oral administration of BAY 43-9006 in cycles of 21 days on/7 days off.
  • Dose escalation from 50 to 800 mg twice daily in 44 patients.

Main Results:

  • The maximum tolerated dose (MTD) was determined to be 400 mg twice daily.
  • Common adverse events included gastrointestinal, dermatologic, and constitutional symptoms.
  • Antitumor activity was observed, with one partial response in renal cell carcinoma and stable disease in 16 patients.

Conclusions:

  • Oral BAY 43-9006 is safe and well-tolerated in patients with advanced solid tumors at the tested doses.
  • The drug exhibits promising antitumour activity, warranting further investigation.
  • Pharmacokinetic analysis showed rapid absorption and dose-dependent exposure.

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