An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma
This is a multi-center, open-label, dose escalation study intended to identify the MTD of
atiprimod alone and the MTD of atiprimod when given in combination with ursodiol. The
atiprimod dose will be escalated in sequential cohorts. Ten dose levels of atiprimod are
planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420,
and 480 mg/day to be given orally. Six dose levels of atiprimod are planned for the
atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480
mg/day to be given orally. The dose of ursodiol will remain constant for all cohorts (300
mg ursodiol orally three times a day everyday). Up to 105 patients will participate
depending on the level at which toxicity is observed. Patients will be assigned to dose
level in the order of study entry.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this study is to identify the maximum tolerated dose
1 year
No
Gary Jacob, PhD
Study Director
Callisto Pharmaceuticals
United States: Food and Drug Administration
CP-101
NCT00086216
May 2004
November 2007
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |