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Completed

NCT Number: NCT01611623

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SNX-5422

Drug

Tablets dose every other day; dose escalation based on safety

Primary outcomes

  1. Number of patients with dose limiting toxicities

    Time frame: First 28 day cycle

    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

Secondary outcomes

  1. Pharmacokinetic profiles of parent drug and metabolite

    Time frame: Day 1 and Day 21 first cycle

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

  2. Number of patients with adverse events as a measure of tolerability

    Time frame: Day 28 of each cycle

    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).

Sponsors and collaborators

Lead sponsor

Esanex Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 5, 2012
Registry last updated
Apr 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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