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Tissue-Based Trials: Windows of Opportunity in Neuro-Oncology Drug Development
Charuta G Furey1, Rian Chang2, An-Chi Tien3
1Department of Neurosurgical Oncology, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, 350 West Thomas Road, Phoenix, AZ 85013, USA; Ivy Brain Tumor Center, Barrow Neurological Institute, Phoenix, AZ 85013, USA.
Abstract:
Tissue-based trials use limited exposure to investigational agents to obtain human tumor pharmacokinetic and pharmacodynamic data early in development. This approach is particularly valuable in neuro-oncology, where preclinical models are imperfect and the blood-brain barrier complicates conventional drug development. Phase 0 and related tissue-based studies directly test whether an agent reaches the tumor, engages its intended target, and elicits the expected biological effect. This chapter describes the rationale and regulatory framework for tissue-based trials, distinguishes the principal designs, and addresses their operational requirements and interpretation.
