Primary Outcome Measures:
- determine the maximum tolerated dose (MTD) of oral AP23573 in combination with doxorubicin [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Describe the antitumor activity of the study drug combination for each dosing schedule [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- examine the pharmacokinetics of oral AP23573 and doxorubicin when given in combination [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Examine pharmacodynamic characteristics of AP23573 for those patients enrolled into the expanded MTD cohorts only [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Intervention Details:
Drug: AP23573
Different schedules and routes of administration of AP23573 will be examined. For each schedule, AP23573 + Doxorubicin will be co-administered on Day 1 of a 3-week cycle. AP23573 will be given orally and will range in dose from 10-30 mg per dose.
Drug: Doxorubicin
administered at 60 mg/m2 intravenously every 3 weeks
The primary objective is to determine the maximum tolerated dose (MTD) of AP23573 in combination with doxorubicin, to characterize the safety profile of AP23573 in combination with doxorubicin, and to examine the pharmacokinetics of AP23573 and doxorubicin when given in combination to patients with advanced malignancies.