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

Esanex Inc.9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

SNX-5422DRUG

Tablets dose every other day; dose escalation based on safety

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients with dose limiting toxicities

Number of patients with dose limiting toxicities defined as Grade 3 or higher on the CTCAE version 4.03 clearly related to disease progression in each dose cohort during the first cycle of study drug administration

Time frame: First 28 day cycle

Secondary Outcomes

Pharmacokinetic profiles of parent drug and metabolite

Assessment of standard pharmacokinetic parameters including area under the plasma-concentration time curve, volume of distribution, clearance elimination half life

Time frame: Day 1 and Day 21 first cycle

Number of patients with adverse events as a measure of tolerability

Frequency and severity of AEs, changes in vital signs (including self-reported pain), ECG, physical examination, and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis).

Time frame: Day 28 of each cycle

Data from ClinicalTrials.gov

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