A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2002-10-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of
XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive
weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment
cycle).
Secondary Objectives :
- To define the safety profile of the drug
- To establish the recommended dose and time interval for future Phase II trials
- To determine the pharmacokinetic (PK) profile of XRP6258 in man
- To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose
(following Protocol Amendment No. 2)
- To look for evidence of antitumor activity