CORT has opened a phase I-II study of sapacitabine for second-line therapy of unresectable advanced or metastatic non-small cell lung cancer (NSCLC). Sapacitabine is an oral nucleoside analog prodrug that acts through a dual mechanism. The compound interferes with DNA synthesis by causing single-strand DNA breaks and induces arrest of the cell division cycle at G2 phase.
Both sapacitabine and its major metabolite, CNDAC, have demonstrated potent anti-tumor activity in both blood and solid tumors in preclinical studies. In a liver metastatic mouse model, sapacitabine was shown to be superior to gemcitabine (Gemzar®; Lilly) or 5-FU, two widely used nucleoside analogs, in delaying the onset and growth of liver metastasis.
A number of clinical trials are evaluating sapacitabine in both solid and hematological tumors to establish a foundation for future Phase 2 studies and combination studies with other anti-cancer agents. Three Phase 1 studies have been completed, which evaluated safety and pharmacokinetics of a variety of dosing schedules in approximately 120 patients with solid tumors. Sapacitabine is currently being evaluated in Phase 2 trials in patients with advanced cutaneous T-cell lymphoma (CTCL), in elderly patients with acute myeloid leukemias (AML), and in therapy of NSCLC.
For more information about the CORT study in NSCLC, contact a CORT Research Coordinator at 972-566-5588 (Dallas), or 972-981-4012 (Plano). Addtional information may be found at the CORT website: www.CORTPA.com.
Tags: clinical trial, Locally Advanced, Metastatic, non-small cell lung cancer, NSCLC, nucleoside analogue, oral drug therapy, sapacitabine, second-line
January 29, 2009 at 12:52 am |
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