ARMOR (Androgen Receptor Modulation Optimized for Response) is Tokai's clinical program for the evaluation of TOK-001. The first clinical trial in that program, ARMOR1, is a Phase 1/2 open-label trial that will assess both safety and efficacy of once-daily treatment with TOK-001 in patients with castration resistant prostate cancer (CRPC). The Phase 1 component of the trial is a multiple-dose safety study to evaluate escalating dose levels of TOK-001 and is expected to enroll 10 patients. The Phase 2 portion of the trial is expected to enroll 40 patients, who will receive one of two target dosing regimens as identified by the Phase 1 results. The primary endpoints of the Phase 1/2 trial are safety and reduction in prostate-specific antigen (PSA) levels from baseline levels measured at first visit. Patients who respond to therapy will have the opportunity to continue treatment with TOK-001 in an extension arm of the trial. Read more about ARMOR1 clinical trial initiation.
The Phase 1/2 trial is being conducted at leading prostate cancer treatment centers in the Unites States, including the Cancer Centers of the Carolinas/Greenville Hospital System University Medical Center, Comprehensive Cancer Centers of Nevada, Dana-Farber Cancer Institute, Fred Hutchinson/University of Washington Cancer Consortium, Roswell Park Cancer Institute, San Bernardino Urological Associates, Sidney Kimmel Comprehensive Cancer Center and University of California, Los Angeles. Please visit www.clinicaltrials.gov for clinical trial details and enrollment information.
