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NCT00506805 Clinical Trial

Safety And Pharmacology Study Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies

Cancer Clinical Trial

Official title:
A Phase 1, Open-label, Dose-escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies Or Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00506805
Other study ID # B1311001
Secondary ID SNX-5422-CLN1-00
Status Completed
Phase Phase 1
First received July 24, 2007
Last updated May 25, 2012
Start date June 2007
Est. completion date March 2010

Study information
Verified date May 2012
Source Esanex Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 and efficacy in patients with cancer.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SNX-5422
dose escalated, tablets every other day; undetermined duration until disease progression

Locations
Country Name City State
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Scottsdale Arizona

Sponsors (3)
Lead Sponsor Collaborator
Esanex Inc. Pfizer, Serenex, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary adverse events and other safety assessments continuous Yes
Secondary tumor response measured by X-rays or scans after every 2 cycles No
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