The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies.
The primary objective of the trial is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies by evaluating the response rates as defined for the individual malignancy categories. Secondary objectives include evaluating time to disease progression, progression-free survival and duration of response; evaluating the pharmacokinetic and pharmacodynamic characteristics of AP23573; describing health-related quality of life measurements; and exploring the safety and tolerability of AP23573 at the specified dose level. Protocol Outline: Open label, non-randomized parallel cohorts of five disease-specific cohorts with a minimum of 21 patients per cohort. Each patient receives a fixed dose of AP23573 administered intravenously (IV) over 30 minutes daily for five days (QDx5) to be repeated every 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks
University of Chicago Hospitals, Section of Hematology/Oncology
Chicago, Illinois, United States
Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place
St Louis, Missouri, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
To assess efficacy of AP23573 in patients with relapsed or refractory hematologic malignancies.
Time frame: Duration of study
Evaluating time to progression, progression-free survival, duration of response and safety
Time frame: Duration of study
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