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

Sponsor

Esanex Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01611623

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: SNX-5422	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: SNX-5422 Tablets dose every other day; dose escalation based on safety

Arm

Intervention/Treatment

Experimental: 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

Drug: SNX-5422

Tablets dose every other day; dose escalation based on safety

Outcome Measures

Primary Outcome Measures

Number of patients with dose limiting toxicities [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 Outcome Measures

Pharmacokinetic profiles of parent drug and metabolite [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
Number of patients with adverse events as a measure of tolerability [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Esanex Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Esanex Inc.

ClinicalTrials.gov Identifier:

NCT01611623

Other Study ID Numbers:

SNX-5422-CLN1-004

First Posted:

Jun 5, 2012

Last Update Posted:

Apr 2, 2013

Last Verified:

Mar 1, 2013

Keywords provided by Esanex Inc.

Solid tumor malignancy

Hsp90

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Apr 2, 2013