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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
There are sequential dosage cohorts ranging from 3 mg - 225 mg per dose. AP23573 is given intravenously over 30 minutes, administered once daily for 5 days every 2 weeks.
Cancer Therapy and Research Center, University of Texas Health Center at San Antonio
San Antonio, Texas, United States
To determine safety, tolerability, and maximum tolerated dose of AP23573 when administered once daily for 5 days on a every 2 week schedule
Time frame: Duration of study
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