NCT01611623

Safety and Pharmacology Study of SNX-5422 in Subjects With Refractory Solid Tumor Malignancies

A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of SNX-5422 in Subjects With Refractory Solid Tumor Malignancies or Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Esanex Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety in patients with cancer.

Detailed description

Correlation has been observed between Hsp90 client protein level changes and functional effects in cells in in vitro studies of SNX-5422, supporting inhibition of Hsp90 as the mechanism of action for this compound. SNX-5422 has demonstrated significant antitumor activity in mouse xenograft models of human tumors, including breast (BT474, MX-1), colon (HT29), prostate (PC3), and melanoma (A375) with multiple oral dosing regimens. This study will employ critical risk management features including the use of the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, which provides a scale for consistently grading the severity of AEs, toxicity criteria analyses for dose escalation, frequent laboratory and clinical observations, correlation of AEs with plasma concentrations of drug, monitoring of the QTc interval at appropriate time points, and a conservative dose-escalation scheme.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	SNX-5422	Tablets dose every other day; dose escalation based on safety

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-11-01
• Completion: 2013-03-01
• First posted: 2012-06-05
• Last updated: 2013-04-02