The primary objective of the Phase I combination study is to determine the recommended dose of seliciclib in combination with Tarceva. Secondary objectives include the evaluation of potential pharmacokinetic interactions between seliciclib and Tarceva and potential alterations of signal transduction biomarkers occurring downstream of EGFR, such as cyclin D1, by the combination of these two agents.
The Phase I combination study of seliciclib and Tarceva will be led by Emiliano Calvo, co-director of the Early Drug Development Program at Vall d’Hebron University Hospital, Barcelona, Spain.
Seliciclib, Cyclacel’s orally available cyclin dependent kinase inhibitor, has shown encouraging anti-cancer activity in several Phase I and Phase II studies. Seliciclib is currently being tested as a single agent in the treatment of patients with non-small cell lung cancer in the Phase IIb Appraise trial and in a Phase II study in patients with nasopharyngeal cancer.