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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Esanex Inc.
ClinicalTrials.gov Identifier:
NCT00647764
First received: March 27, 2008
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  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
Solid Tumor Malignancy
Lymphoid Malignancy (Lymphoma and CLL)
Leukemia
Lymphoma
 Drug: SNX-5422 Mesylate Hsp90 inhibitor
 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: Phase 1 Study Of SNX-5422 Mesylate In Adults With Refractory Solid Tumor Malignancies And Lymphomas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Esanex Inc.:

Primary Outcome Measures:
  • MTD, safety and toxicity [ Time Frame: continuous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetic profile of SNX-5422 [ Time Frame: first cycle ] [ Designated as safety issue: No ]
  • tumor response measured by X-rays or scans [ Time Frame: after every 2 cycles ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: SNX-5422 Mesylate Hsp90 inhibitor
dose escalated, tablets twice a week; 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00647764     History of Changes
Other Study ID Numbers: B1311003, PO7318
Study First Received: March 27, 2008
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013