Phase I Study of the Hsp90 Inhibitor, AT13387, in Adults With Refractory Solid Tumors
- Define the safety and tolerability of Hsp90 inhibitor AT13387 (AT13387) in adult
patients with refractory solid tumors.
- Establish the maximum-tolerated dose (MTD) of AT13387 in adult patients with refractory
- Determine the pharmacokinetics of AT13387 in patients with refractory solid tumors.
- Assess pharmacodynamic markers of Hsp90 inhibition and modulation of Hsp90 client
proteins by AT13387 in tumor tissue, serum, and PBMCs.
OUTLINE: This is a dose-escalation study followed by an expansion phase.
Patients receive Hsp90 inhibitor AT13387 IV over 1 hour on days 1, 2, 8, 9, 15, and 16.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood, urine, and tissue collection at baseline and periodically during the
study for pharmacokinetic and pharmacodynamic studies.
After completion of study therapy, patients are followed up for 30 days.
Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of Hsp90 inhibitor AT13387 (AT13387)
Shivaani Kummar, MD
NCI - Medical Oncology Branch
|NCI - Developmental Therapeutics Clinic||Bethesda, Maryland 20892|