This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral, once a day, 14 days on 14 days off
MD Anderson Cancer Center
Houston, Texas, United States
The primary objective of this study is to identify the maximum tolerated dose
Time frame: 1 year
The secondary objective of this study is to measure the pharmacokinetics of
Time frame: 1 year
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