Redefining the primary objective of phase I oncology trials
- 5 August 2014
- journal article
- Published by Springer Science and Business Media LLC in Nature Reviews Clinical Oncology
- Vol. 11 (9), 503-504
- https://doi.org/10.1038/nrclinonc.2014.135
Abstract
Cytotoxic agents are conventionally dosed on the basis of the maximum tolerated dose defined in phase I trials. A study assessing adverse events in over 2,000 patients treated with molecularly targeted agents suggests a need to redefine criteria for dosing of molecularly targeted agents, which should be based on randomized, dose-ranging phase II trials.Keywords
This publication has 7 references indexed in Scilit:
- Defining dose-limiting toxicity for phase 1 trials of molecularly targeted agents: Results of a DLT-TARGETT international surveyEuropean Journal of Cancer, 2014
- Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents – Dose-Limiting Toxicity and Toxicity Assessment Recommendation Group for Early Trials of Targeted therapies, an European Organisation for Research and Treatment of Cancer-led studyEuropean Journal Of Cancer, 2014
- Ceritinib inALK-Rearranged Non–Small-Cell Lung CancerNew England Journal of Medicine, 2014
- Playing Russian Roulette With Tyrosine Kinase InhibitorsClinical Pharmacology & Therapeutics, 2012
- The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double‐blind, placebo‐controlled phase IIa trial of three dosage levels of CP‐690,550 versus placeboArthritis & Rheumatism, 2009
- Randomized Phase II Study of Multiple Dose Levels of CCI-779, a Novel Mammalian Target of Rapamycin Kinase Inhibitor, in Patients With Advanced Refractory Renal Cell CarcinomaJournal of Clinical Oncology, 2004
- A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol acetate in postmenopausal patients with advanced breast cancerEuropean Journal Of Cancer, 1996