Multiple Myeloma Clinical Trial
Official title:
A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Daily x 5 Administration of AP23573, an mTOR Inhibitor, in Patients With Refractory or Advanced Malignancies
Phase 1 trial to determine the safety, tolerability and maximum tolerated dose (MTD) of AP23573 in patients with refractory or recurrent malignancies, including myeloma and lymphoma.
The primary objectives of the study are to determine the safety, tolerability, and MTD of
AP23573, when administered once daily for 5 days to be repeated every 2 weeks (two 2-week
courses equals 1 cycle). The secondary objectives of the study are to characterize the
pharmacokinetic profile of AP23573, to evaluate potential pharmacodynamic markers of
AP23573, and to obtain preliminary information on the antineoplastic activity of AP23573.
Protocol Outline: This is a dose-escalation study. Patients receive AP23573 over 30 minutes
by intravenous infusion once daily for 5 days to be repeated every 2 weeks. If tolerated, a
total of at least 2 cycles will be administered (8-week treatment period). Treatment repeats
every 4 weeks in the absence of disease progression or unacceptable toxicity.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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