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

This study has been completed.
Sponsor:
Collaborators:
Serenex, Inc.
Pfizer
Information provided by (Responsible Party):
Esanex Inc.
ClinicalTrials.gov Identifier:
NCT00506805
First received: July 24, 2007
Last updated: May 25, 2012
Last verified: May 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • tumor response measured by X-rays or scans [ Time Frame: after every 2 cycles ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Esanex Inc.
ClinicalTrials.gov Identifier: NCT00506805     History of Changes
Other Study ID Numbers: B1311001, SNX-5422-CLN1-001
Study First Received: July 24, 2007
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2014