Safety And Pharmacology Study Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies

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NCT00506805

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Study Location
Pfizer Investigational Site
Scottsdale, Arizona, 85258, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- >18 years old

- histologically confirmed solid tumor malignancy

- refractory to available therapy or for which no therapy is available

- adequate organ function

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- CNS malignancy


- significant GI disease


- at risk for prolonged QT interval

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Pharmacology Study Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies
Official Title  ICMJE A Phase 1, Open-label, Dose-escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Solid Tumor Malignancies Or Non-Hodgkin's Lymphoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE Drug: SNX-5422
dose escalated, tablets every other day; undetermined duration until disease progression
Study Arms  ICMJE Experimental: Single Arm
Intervention: Drug: SNX-5422
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2010)		44
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2007)		69
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • >18 years old
  • histologically confirmed solid tumor malignancy
  • refractory to available therapy or for which no therapy is available
  • adequate organ function

Exclusion Criteria:

  • CNS malignancy
  • significant GI disease
  • at risk for prolonged QT interval
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00506805
Other Study ID Numbers  ICMJE B1311001
SNX-5422-CLN1-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Esanex Inc.
Study Sponsor  ICMJE Esanex Inc.
Collaborators  ICMJE
  • Serenex, Inc.
  • Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Esanex Inc.
Verification Date May 2012

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