Lymphoma Clinical Trial
Official title:
A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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