Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas
Primary Purpose
Solid Tumor Malignancy, Lymphoid Malignancy (Lymphoma and CLL), Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SNX-5422 Mesylate Hsp90 inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor Malignancy
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
MTD, safety and toxicity
Secondary Outcome Measures
pharmacokinetic profile of SNX-5422
tumor response measured by X-rays or scans
Full Information
NCT ID
NCT00647764
First Posted
March 27, 2008
Last Updated
May 15, 2012
Sponsor
Esanex Inc.
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00647764
Brief Title
Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas
Official Title
Phase 1 Study Of SNX-5422 Mesylate In Adults With Refractory Solid Tumor Malignancies And Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Esanex Inc.
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor Malignancy, Lymphoid Malignancy (Lymphoma and CLL), Leukemia, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SNX-5422 Mesylate Hsp90 inhibitor
Intervention Description
dose escalated, tablets twice a week; undetermined duration until disease progression
Primary Outcome Measure Information:
Title
MTD, safety and toxicity
Time Frame
continuous
Secondary Outcome Measure Information:
Title
pharmacokinetic profile of SNX-5422
Time Frame
first cycle
Title
tumor response measured by X-rays or scans
Time Frame
after every 2 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1311003&StudyName=Safety%20Study%20Of%20SNX-5422%20To%20Treat%20Solid%20Tumor%20Cancers%20And%20Lymphomas
Description
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Safety Study Of SNX-5422 To Treat Solid Tumor Cancers And Lymphomas
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