AT13387 in Treating Patients With Refractory Solid Tumors
Recruitment status was Recruiting
RATIONALE: AT13387 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I clinical trial is studying the side effects and best dose of AT13387 in treating patients with refractory solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: Hsp90 inhibitor AT13387
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of the Hsp90 Inhibitor, AT13387, in Adults With Refractory Solid Tumors|
- Safety and tolerability of Hsp90 inhibitor AT13387 (AT13387) [ Designated as safety issue: Yes ]
- Maximum-tolerated dose and recommended phase II dose of AT13387 [ Designated as safety issue: Yes ]
- Pharmacokinetics of AT13387 [ Designated as safety issue: No ]
- Pharmacodynamic markers of Hsp90 inhibition and modulation of Hsp90 client proteins by AT13387 in tumor tissue, serum, and PBMCs [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
- 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 solid tumors.
- 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.
|United States, Maryland|
|NCI - Developmental Therapeutics Clinic||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Shivaani Kummar, MD 301-435-5402 firstname.lastname@example.org|
|Principal Investigator:||Shivaani Kummar, MD||NCI - Medical Oncology Branch|