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A phase I study of subcutaneously administered aflibercept (VEGF trap) in a new formulation in patients with advanced

Andrea Wang-Gillam1, William P Tew, Mace L Rothenberg

  • 1Washington University School of Medicine, St. Louis, MO 63110, USA.

Investigational New Drugs
|October 18, 2011
PubMed

Insights

A new subcutaneous formulation of aflibercept effectively targets vascular endothelial growth factor (VEGF) in patients with advanced solid tumors. This phase I study assessed the safety, pharmacokinetics, and efficacy of the novel aflibercept formulation.

Area of Science:

  • Oncology
  • Pharmacology
  • Biochemistry

Background:

  • Targeting tumor angiogenesis, the formation of new blood vessels, is a key anti-cancer strategy.
  • Vascular Endothelial Growth Factor (VEGF) plays a critical role in angiogenesis.
  • Aflibercept is a fusion protein designed to inhibit VEGF signaling.

Purpose of the Study:

  • To evaluate the safety, pharmacokinetic profile, and efficacy of a new 100 mg/mL subcutaneous (SC) formulation of aflibercept.
  • To assess aflibercept's potential as a targeted anti-angiogenesis therapy in patients with advanced solid tumors.

Main Methods:

  • Phase I clinical trial.
  • Subcutaneous administration of aflibercept at 4 mg/kg every 2 weeks.
  • Evaluation of toxicity, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors.

Main Results:

  • The new subcutaneous aflibercept formulation was evaluated for toxicity, pharmacokinetics, and efficacy.
  • Data on the safety, drug absorption, distribution, metabolism, and excretion were collected.
  • Preliminary efficacy signals in patients with advanced solid tumors were observed.

Conclusions:

  • The subcutaneous formulation of aflibercept offers a potentially convenient administration route for anti-angiogenesis therapy.
  • Further investigation is warranted to confirm the efficacy and optimal use of this new aflibercept formulation in cancer treatment.

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