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Safety And Pharmacology Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies

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.
 
ClinicalTrials.gov Identifier: NCT00595686
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : May 17, 2012
Sponsor:
Collaborator:
Serenex, Inc.
Information provided by:
Esanex Inc.

Study Description
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Brief Summary:
Hsp90 is a chemical in the body that is involved in the 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 or disease Intervention/treatment Phase
Hematologic Neoplasms Drug: SNX-5422 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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 Hematological Malignancies
Study Start Date : January 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm Drug: SNX-5422
dose escalated; tablets every other day; undetermined duration until disease progression


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

Secondary Outcome Measures :
  1. disease response specific to the hematological malignancy [ Time Frame: after every 2 cycles ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years old
  • Karnofsky performance status > 60
  • confirmed hematological malignancy
  • refractory to available therapy or for which no therapy is available
  • adequate hepatic, renal and hematological function

Exclusion Criteria:

  • CNS malignancy
  • at risk for prolonged QT interval
  • significant GI/liver disease
  • other serious concurrent illness or medical condition
Contacts and Locations
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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): NCT00595686


Locations
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United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30912
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Esanex Inc.
Serenex, Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00595686    
Other Study ID Numbers: B1311002
SNX-5422-CLN1-002
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012
Keywords provided by Esanex Inc.:
Hematologic Malignancies Hsp90 Hematologic Malignancy
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases