Primary Outcome Measures:
- To determine the safety, tolerability and maximum tolerated dose (MTD) of AP23573 when administered orally as an enteric or film coated tablet to patients with progressive or recurrent malignancies. Several dosage regimens will be examined in this trial [ Time Frame: Complete duration of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Examine pharmacokinetic and pharmacodynamic characteristics of AP23573 (e.g., AP23573 blood levels, phospho-4E-BP1 levels, plasma partitioning) [ Time Frame: Complete duration of study ] [ Designated as safety issue: No ]
- Describe the antitumor activity of the study drug regimens [ Time Frame: Complete duration of the study ] [ Designated as safety issue: No ]
Intervention Details:
Drug: AP23573
10 mg tablet of AP23573 administered orally according to one of six different dosing regimens for a four-week treatment cycle.
The advent of oral anticancer therapy has created a means to reduce dependency on a system for treating cancer that relies on hospital-based services to administer treatment. While known disadvantages of oral therapies such as potential variable absorption, unpredictable bioavailability and sometimes poor patient compliance pose challenges, the use of orally administered compounds permits investigation of alternative or varied dose regimens, which may ultimately enhance overall patient care.
AP23573 is currently being studied in phase 1 and phase II clinical trials in patients with advanced cancers. Thus far, these trials have demonstrated that AP23573 has a favorable safety profile and possesses anticancer activity when administered as a 30-minute intravenous (IV) infusion daily x 5 every-two-weeks or on a weekly schedule. The primary objective of this current phase I trial is to study the safety and tolerability of an orally administered dosage form of AP23573. This will be accomplished by an ascending dose study of several dosage regimens in patients with advanced malignancies.