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

NCT ID: NCT01611623

Last Updated: 2013-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SNX-5422

Open label administration of SNX-5422 tablets every other day for 21 days on a 28 day cycle. Dose escalation based on safety outcomes

Group Type: EXPERIMENTAL

SNX-5422

Intervention Type: DRUG

Tablets dose every other day; dose escalation based on safety

Interventions

SNX-5422

Tablets dose every other day; dose escalation based on safety

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• >18 years old histologically confirmed solid tumor malignancy refractory to available therapy or for which no therapy is available adequate organ function

Exclusion Criteria

• CNS malignancy significant GI disease at risk for prolonged QT interval

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esanex Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SNX-5422-CLN1-004

Identifier Type: -

Identifier Source: org_study_id