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Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas

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ClinicalTrials.gov Identifier: NCT00647764
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : May 17, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Esanex Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumor Malignancy Lymphoid Malignancy (Lymphoma and CLL) Leukemia Lymphoma Drug: SNX-5422 Mesylate Hsp90 inhibitor Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study Of SNX-5422 Mesylate In Adults With Refractory Solid Tumor Malignancies And Lymphomas
Study Start Date : March 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm Drug: SNX-5422 Mesylate Hsp90 inhibitor
dose escalated, tablets twice a week; undetermined duration until disease progression



Primary Outcome Measures :
  1. MTD, safety and toxicity [ Time Frame: continuous ]

Secondary Outcome Measures :
  1. pharmacokinetic profile of SNX-5422 [ Time Frame: first cycle ]
  2. tumor response measured by X-rays or scans [ Time Frame: after every 2 cycles ]


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:

  • 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

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): NCT00647764


Locations
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Esanex Inc.
National Cancer Institute (NCI)
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00647764     History of Changes
Other Study ID Numbers: B1311003
PO7318
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases