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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506805
First Posted: July 25, 2007
Last Update Posted: May 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Serenex, Inc.
Pfizer
Information provided by (Responsible Party):
Esanex Inc.
  Purpose
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.

Condition Intervention Phase
Cancer Drug: SNX-5422 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Mesylate In Subjects With Refractory Solid Tumor Malignancies Or Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Esanex Inc.:

Primary Outcome Measures:
  • adverse events and other safety assessments [ Time Frame: continuous ]

Secondary Outcome Measures:
  • tumor response measured by X-rays or scans [ Time Frame: after every 2 cycles ]

Enrollment: 44
Study Start Date: June 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: SNX-5422
dose escalated, tablets every other day; undetermined duration until disease progression

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506805


Locations
United States, Arizona
Pfizer Investigational Site
Scottsdale, Arizona, United States, 85258
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Esanex Inc.
Serenex, Inc.
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Esanex Inc.
ClinicalTrials.gov Identifier: NCT00506805     History of Changes
Other Study ID Numbers: B1311001
SNX-5422-CLN1-001
First Submitted: July 24, 2007
First Posted: July 25, 2007
Last Update Posted: May 28, 2012
Last Verified: May 2012

Keywords provided by Esanex Inc.:
solid tumor malignancy; Hsp90

Additional relevant MeSH terms:
Neoplasms