PD18-04 A PHASE 1 SAFETY STUDY OF ONCOFID-P-B ADMINISTERED FOR 12 CONSECUTIVE WEEKS IN BCG UNRESPONSIVE/INTOLERANT PATIENTS WITH BLADDER CARCINOMA IN SITU (CIS): PRELIMINARY RESULTS

INTRODUCTION AND OBJECTIVES:Oncofid-P-B (Fidia Farmaceutici) is a novel water-soluble muco-adhesive conjugate of paclitaxel-hyaluronic acid (P-HA. Very favorable safety and efficacy after 6 weeks in BCG unresponsive CIS patients and after 6 weeks followed by 6+6 months in Ta G1-G2 patients was previously reported. The excellent safety profile prompted the design of this trial to assess safety, tolerability and efficacy of P-HA administered for 12 consecutive weeks, followed by 12 monthly instillations, in BCG unresponsive/intolerant CIS patients.METHODS:This is an open-label, single arm, multicenter study to assess safety, tolerability and efficacy of P-HA administered in 20 patients with CIS, who are unresponsive or intolerant to BCG and unwilling or unfit for cystectomy. P-HA was administered weekly by intravesical instillation for 12 consecutive weeks (intensive phase), followed, in responsive patients, by 12 monthly instillations (maintenance). The primary end-point is the overall safety profile. Seco...