A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors

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

Timeline

Start

1999-10

Primary completion

2002-08

Completion

2002-10

Publications

• Fumoleau P, Trigo JM, Isambert N, Semiond D, Gupta S, Campone M. Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours. BMC Cancer. 2013 Oct 7;13:460. doi: 10.1186/1471-2407-13-460.

Drugs

Indications