Phase I study of the oral platinum agent satraplatin (S) in sequential combination with capecitabine (C) in patients with advanced solid tumours

2560 Background: S is a novel, oral platinum (P) analogue with a preclinical safety and activity profile comparable to carboplatin. C is an oral pro-drug of 5’-DFUR approved as single agent or in combination with other cytotoxic agents for the treatment of breast and colon cancer. A sequential administration schedule of S and C was assessed in an open-label phase Ib study in adult patients (pts) with advanced solid tumours. Methods: S was given QD to fasting pts from d1 to 5, C BID from d8 to 21 of a 4-week cycle. The starting daily doses were S 60 mg/m2 and C 1,650 mg/m2 (825 BID). Prophylactic oral 5HT 3 antagonists and steroids were given 30–60 min before S. Three to six pts were entered per dose level (DL). The maximum tolerated dose (MTD) was one dose level below the dose at which ≥2 of 3 or ≥2 of 6 pts experienced dose-limiting toxicities (DLTs). Eligibility criteria included ECOG PS ≤2, adequate renal/liver function, ≤2 lines of prior chemotherapies (CTs) for advanced disease, lack of resistance to...