- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00647764
Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas
May 15, 2012 updated by: Esanex Inc.
Phase 1 Study Of SNX-5422 Mesylate In Adults With Refractory Solid Tumor Malignancies And Lymphomas
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
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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
-
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Maryland
-
Bethesda, Maryland, United States, 20892
- Pfizer Investigational Site
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-
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:
- Solid tumors or lymphoid malignancies refractory to standard therapy
- measurable disease
- recovery to Grade < 1 toxicity due to prior adverse event or chemotherapy
- no chemotherapy within 4 weeks of entering study
- Age > 18 years
- Karnofsy >= 60%
- Life expectancy > 3 months
- normal or adequate organ and marrow function
Exclusion Criteria:
- receiving other investigational agents
- brain metastases
- uncontrolled medical illness
- HIV+ receiving combination antiretroviral therapy
- significant GI disease
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 twice a week; undetermined duration until disease progression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MTD, safety and toxicity
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
|
pharmacokinetic profile of SNX-5422
Time Frame: first cycle
|
first cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
March 1, 2008
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
March 27, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
May 17, 2012
Last Update Submitted That Met QC Criteria
May 15, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1311003
- PO7318
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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Clinical Trials on SNX-5422 Mesylate Hsp90 inhibitor
-
Esanex Inc.Completed
-
Esanex Inc.Completed
-
Esanex Inc.Pfizer; Serenex, Inc.Completed
-
National Cancer Institute (NCI)Completed
-
Esanex Inc.Serenex, Inc.CompletedHematologic NeoplasmsUnited States
-
Esanex Inc.TerminatedCancerUnited States
-
Esanex Inc.Terminated
-
Esanex Inc.Completed
-
Esanex Inc.Completed