Phase I study of RX-0201 in patients with advanced or metastatic solid tumors

13102 Background: RX-0201 is a 20-mer oligonucleotide that is complementary to Akt-1 mRNA. Strong evidence exists that Akt plays a very important role in cancer progression by stimulating cell proliferation and inhibiting apoptosis. Over-expression of constitutively activated Akt in many cell types promotes cellular transformation. In addition to reducing Akt mRNA levels and inhibiting the expression of Akt protein, in vitro pharmacology studies have demonstrated that RX-0201 suppressed cell proliferation in carcinomas of the brain, breast, cervix, colon, head & neck, kidney, liver, lung, ovary, pancreas, prostate, stomach and melanoma. In vivo studies have also shown that RX-0201 significantly inhibits the growth of tumor in human prostate and brain cancer of nude mice models. This study is designed to determine the maximum tolerated RX-0201 dose in patients with advanced malignancies. Methods: Patients with solid tumors for whom no standard therapies exist, Karnofsky PS>70, adequate hepatic and renal fu...