- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00506805
Safety And Pharmacology Study Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies
May 25, 2012 updated by: Esanex Inc.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Pfizer Investigational Site
-
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Tennessee
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Nashville, Tennessee, United States, 37203
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
|
dose escalated, tablets every other day; undetermined duration until disease progression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
adverse events and other safety assessments
Time Frame: continuous
|
continuous
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tumor response measured by X-rays or scans
Time Frame: after every 2 cycles
|
after every 2 cycles
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
July 24, 2007
First Submitted That Met QC Criteria
July 24, 2007
First Posted (Estimate)
July 25, 2007
Study Record Updates
Last Update Posted (Estimate)
May 28, 2012
Last Update Submitted That Met QC Criteria
May 25, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1311001
- SNX-5422-CLN1-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Esanex Inc.Terminated
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Esanex Inc.Completed