A Phase I Dose-Escalation Study of AG2037 Administered Once Weekly for Three Weeks to Patients With Advanced Cancer
- Determine the maximum tolerated dose and dose-limiting toxic effects of AG2037 in
patients with advanced, metastatic, or recurrent solid tumor.
- Determine the safety and tolerance of this drug in these patients.
- Assess the pharmacokinetics of this drug in these patients.
- Document any antitumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive AG2037 IV weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 6
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of AG2037 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
patients experience dose-limiting toxicity.
Patients are followed weekly for 4 weeks.
PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.
Primary Purpose: Treatment
Francisco Robert, MD, FACP
University of Alabama at Birmingham
United States: Federal Government
|Arizona Cancer Center||Tucson, Arizona 85724|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|