Number: 201107068 Principal Investigator: Lockhart, A. Craig
Title: Phase I Safety and Pharmacokinetic Study of XRP6258 (Cabazitaxel) In Advanced Solid Tumor Patients with Varying Degrees of Hepatic Impairment
Phase: I Disease Site: Multiple Sites
Participating Site(s):
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The purpose of this study is to determine if Cabazitaxel is a safe treatment for patients with advanced cancers of different types who also have different levels of liver dysfunction. The highest safe dose of cabazitaxel (the maximum tolerated dose, or MTD) that can be given to patients with your level of liver dysfunction will be determined. Based on the results of your liver function tests, you will be placed into 1 of 5 cohorts, or groups of patients. At least 6 patients will be placed in each of cohorts 1-4 and 12 patients will be placed in cohort 5. Each cohort will be given different starting doses of cabazitaxel.If enough patients get through one dose level with acceptable side effects, the next group of patients will get a higher dose of cabazitaxel. This is called dose escalation. If 2 of the 6 patients in each cohort experience unacceptable side effects, we will know that the maximum tolerated dose, or MTD, has been reached and we have found the highest safe dose of cabazitaxel for that particular level of liver dysfunction.
Each patient will participate at only one dose level. Your study doctor will tell you your dose ofcabazitaxel before you begin the study. Your dose of cabazitaxel may be decreased while you are receiving treatment, but it will never go up.
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Internal Protocol Documents (requires Siteman administrative database password)