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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

March 27, 2008
May 15, 2012
March 2008
September 2010   (final data collection date for primary outcome measure)
MTD, safety and toxicity [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00647764 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Solid Tumor Malignancy
  • Lymphoid Malignancy (Lymphoma and CLL)
  • Leukemia
  • Lymphoma
Drug: SNX-5422 Mesylate Hsp90 inhibitor
dose escalated, tablets twice a week; undetermined duration until disease progression
Experimental: Single Arm
Intervention: Drug: SNX-5422 Mesylate Hsp90 inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00647764
B1311003, PO7318
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Esanex Inc.
National Cancer Institute (NCI)
Study Director: Pfizer CT.gov Call Center Pfizer
Esanex Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP