Anticipating Side Effects From Targeted Therapies in Clinical Trials

Grace Dy, MD, associate professor, Department of Medicine, Roswell Park Cancer Institute, discusses the anticipation of side effects from targeted therapies in clinical trials.

Grace Dy, MD, associate professor, Department of Medicine, Roswell Park Cancer Institute, discusses the anticipation of side effects from targeted therapies in clinical trials.

In phase I, first-in-human studies, side effects are difficult to anticipate. As an example, Dy cites a preclinical trial looking at SMAC-mimetic birinapant, which found that patients may be at risk for hypotension and cardiovascular side effects. Protocols were put in place in early phase trials to monitor patients' blood pressure for six hours, but found that patients did not experience cardiovascular side effects.

Clinical Pearls

Dy also says that when MEK inhibitors were first being developed, it was not anticipated that ocular side effects were a target effect. As researchers recognized this though, Dy says, protocol has been put in place to require baseline ophthalmologic exams for new generation MEK inhibitors.

  • Side effects from targeted therapies are difficult to anticipate in first-in-human studies
  • When MEK inhibitors were first being developed, it was not anticipated that ocular side effects were a target effect