Goss G, Hirte H, Batist G, Stewart D, Miller W, Lorimer I, Averbuch S, Abugaber A, Matthews S, Seymour L. NCI-Canada CTG IND Program. Kingston, Canada and Astra Zeneca. Phase I studies of novel agents provide a unique opportunity to test both dose-response and biologic or target effect. IND.122 is a phase I dose seeking study being conducted at 3 NCIC CTG member centres in Ontario and Quebec which incorporates traditional endpoints such as PK, toxicity, efficacy and mandatory PD assessment.
Treatment is continued in the absence of disease progression or unacceptable toxicity.
Fresh tumour samples are shipped centrally and examined for EGFR expression, mutations, EGFR phosphorylation and apoptosis to seek evidence of biologic or target effect. Drug related effects included grade 2 acneiform rash and mild gastrointestinal effects. Complete PK and PD data as well as updated toxicity data will be presented from pts accrued to Part 1. I trials is feasible and does not preclude rapid accrual to such trials.