Spots Global Cancer Trial Database for A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors

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Trial Identification

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

Official Title: A Phase I Dose Finding Study of XRP6258 Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumors

Study ID: NCT01755390

Conditions

Advanced Solid Tumor

Interventions

Cabazitaxel (XRP6258)

Study Description

Brief 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

Detailed Description: The duration of the study will include the following periods: * Pretreatment: 28 to 7 days before first infusion * Treatment: Weekly for the first four consecutive weeks during 5-week treatment cycle * Post-treatment: 3 - 4 weeks after last infusion. Treatment may be continued until disease progression or unacceptable toxicity or patient refusal.