Study of Atiprimod Treatment for Patients With Advanced Cancer
The primary objectives of this study are to identify the maximum tolerated dose (MTD) and to evaluate the safety of atiprimod when given in doses starting at 60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in patients with advanced cancer.
The secondary objectives of this study are to measure the pharmacokinetics of atiprimod and to evaluate the efficacy of atiprimod treatment in patients with advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer|
- Maximum Tolerated Dose (MTD) of Atiprimod [ Time Frame: With each 28 day (4 week) cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Starting Dose of 60 mg/day orally for 14 days of 28 day cycle.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Razelle Kurzrock, MD||M.D. Anderson Cancer Center|