This phase I, dose-escalation trial of GRN163L is primarily designed to demonstrate the safety and tolerability of GRN163L administered intravenously (IV) on a weekly basis in patients with refractory or relapsed solid tumor malignancies.
This study will also evaluate the tolerability of IV infusions of GRN163L at various rates of administration, and enable an assessment of the pharmacokinetic profile of GRN163L at escalating doses and at decreasing infusion durations. A secondary endpoint of the trial is the preliminary evaluation of anti-tumor activity of GRN163L in this patient population.
“Preclinical studies of GRN163L alone, and in combination with approved chemotherapeutic agents, indicate the importance of telomerase as a target for the treatment of cancer, and the potential utility of GRN163L in the treatment of patients with essentially any type of solid tumor malignancy. We are, therefore, very hopeful that our patients may benefit from this new drug,” said Dr Mark Ratain, associate director for clinical sciences at the cancer research center of the University of Chicago.