Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle

• Published in: Clinical cancer research Vol. 22; no. 11; pp. 2613 - 2617
• Main Authors: Jänne, Pasi A., Kim, Geoffrey, Shaw, Alice T., Sridhara, Rajeshwari, Pazdur, Richard, McKee, Amy E.
• Format: Journal Article
• Language: English
• Published: United States 01.06.2016
• Subjects: Antineoplastic Agents - pharmacology; Antineoplastic Agents - therapeutic use; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Approval; Humans; Molecular Targeted Therapy; Neoplasms - drug therapy; Protein Kinase Inhibitors - pharmacology; Protein Kinase Inhibitors - therapeutic use
• ISSN: 1078-0432; 1557-3265; 1557-3265
• DOI: 10.1158/1078-0432.CCR-15-2643

In the current era of rapid marketing approval for promising new products in oncology, dose finding and optimization for small-molecule oncology drugs occurs throughout the development cycle and into the postmarketing setting. Many trials that support a regulatory application have high rates of dose...