Study of Atiprimod Treatment for Patients With Advanced Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00430014|
Recruitment Status : Terminated (Sponsor Withdrew)
First Posted : February 1, 2007
Last Update Posted : February 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Atiprimod||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Starting Dose of 60 mg/day orally for 14 days of 28 day cycle.
- Maximum Tolerated Dose (MTD) of Atiprimod [ Time Frame: With each 28 day (4 week) cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430014
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Razelle Kurzrock, MD||M.D. Anderson Cancer Center|