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Lookup NU author(s): Dr Keith Faulkner
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Purpose To describe the strategy used for large-scale ophthalmological monitoring in the clinical development of the novel anticancer agent gefitinib (`Iressa', ZD1839), an epidermal growth factor receptor tyrosine kinase inhibitor, which had demonstrated ocular effects in preclinical animal models. Methods In this extensive clinical trial programme, patients in Phase I and II trials underwent frequent and intensive ophthalmological monitoring at baseline and during the trials. Data were reviewed by an external independent Ophthalmology Advisory Board. Results Ophthalmological data for 221 patients in Phase I trials of gefitinib and 425 patients in Phase II trials revealed no evidence of any consistent or drug-related ophthalmological toxicity. Interestingly, the baseline data revealed that, in an asymptomatic population, transient ophthalmological events are identified during monitoring. Conclusions This study reports the methodology and normative data in an ophthalmological screening programme that should prove useful for future studies.
Author(s): Tullo AB, Esmaeli B, Murray PI, Bristow E, Forsythe BJ, Faulkner K
Publication type: Review
Publication status: Published
ISSN (print): 0950-222X
ISSN (electronic): 1476-5454