Safety And Pharmacology Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies
Primary Purpose
Hematologic Neoplasms
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SNX-5422
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Neoplasms focused on measuring Hematologic Malignancies Hsp90 Hematologic Malignancy
Eligibility Criteria
Inclusion Criteria:
- >18 years old
- Karnofsky performance status > 60
- confirmed hematological malignancy
- refractory to available therapy or for which no therapy is available
- adequate hepatic, renal and hematological function
Exclusion Criteria:
- CNS malignancy
- at risk for prolonged QT interval
- significant GI/liver disease
- other serious concurrent illness or medical condition
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
adverse events and other safety assessments
Secondary Outcome Measures
disease response specific to the hematological malignancy
Full Information
NCT ID
NCT00595686
First Posted
January 7, 2008
Last Updated
May 15, 2012
Sponsor
Esanex Inc.
Collaborators
Serenex, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00595686
Brief Title
Safety And Pharmacology Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies
Official Title
A Phase 1, Open-label, Dose-Escalation Study Of The Safety And Pharmacokinetics Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Esanex Inc.
Collaborators
Serenex, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hsp90 is a chemical in the body that is involved in the 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
Hematologic Neoplasms
Keywords
Hematologic Malignancies Hsp90 Hematologic Malignancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SNX-5422
Intervention Description
dose escalated; tablets every other day; undetermined duration until disease progression
Primary Outcome Measure Information:
Title
adverse events and other safety assessments
Time Frame
continuous
Secondary Outcome Measure Information:
Title
disease response specific to the hematological malignancy
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:
>18 years old
Karnofsky performance status > 60
confirmed hematological malignancy
refractory to available therapy or for which no therapy is available
adequate hepatic, renal and hematological function
Exclusion Criteria:
CNS malignancy
at risk for prolonged QT interval
significant GI/liver disease
other serious concurrent illness or medical condition
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
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Pfizer Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1311002&StudyName=Safety%20And%20Pharmacology%20Of%20SNX-5422%20Mesylate%20In%20Subjects%20With%20Refractory%20Hematological%20Malignancies
Description
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Learn more about this trial
Safety And Pharmacology Of SNX-5422 Mesylate In Subjects With Refractory Hematological Malignancies
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