Multiple Myeloma Clinical Trial
Official title:
A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Weekly 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 ridaforolimus 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
ridaforolimus when administered once weekly for 4 weeks (4 week cycle). The secondary
objectives of the study are to characterize the pharmacokinetic profile of ridaforolimus, to
evaluate potential pharmacodynamic markers of ridaforolimus, and to obtain preliminary
information on the antineoplastic activity of ridaforolimus.
Protocol Outline: This is a dose-escalation study. Patients receive ridaforolimus over 30
minutes by intravenous infusion once weekly for 8 weeks (two 4-week cycles). 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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