Back to resultsStudy of ZIO-201 in Advanced Sarcoma
Primary Purpose
Advanced Sarcoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ZIO-201
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Sarcoma
Eligibility Criteria
Metastatic and /or unresectable disease state after previous standard chemotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
toxicities
Secondary Outcome Measures
pharmacokinetics
Full Information
NCT ID
NCT00439686
First Posted
February 22, 2007
Last Updated
January 29, 2014
Sponsor
Alaunos Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT00439686
Brief Title
Study of ZIO-201 in Advanced Sarcoma
Official Title
A Phase IB/IIA Study of the Saftey and Activity of Intravenous Isophosporamide Mustard (ZIO-201) in Patients With Advanced Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alaunos Therapeutics
4. Oversight
5. Study Description
Brief Summary
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZIO-201
Intervention Description
ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months
Primary Outcome Measure Information:
Title
toxicities
Time Frame
6 months
Secondary Outcome Measure Information:
Title
pharmacokinetics
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Metastatic and /or unresectable disease state after previous standard chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Lewis, MD, PhD
Organizational Affiliation
ZIOPHARM Oncology, Inc
Official's Role
Study Director
Facility Information:
City
Santa Monica
State/Province
California
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of ZIO-201 in Advanced Sarcoma
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