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Study of ZIO-201 in Advanced Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZIOPHARM
ClinicalTrials.gov Identifier:
NCT00439686
First received: February 22, 2007
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.


Condition Intervention Phase
Advanced Sarcoma
 Drug: ZIO-201
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IB/IIA Study of the Saftey and Activity of Intravenous Isophosporamide Mustard (ZIO-201) in Patients With Advanced Sarcoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ZIOPHARM:

Primary Outcome Measures:
  • toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: February 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: ZIO-201
ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Metastatic and /or unresectable disease state after previous standard chemotherapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439686

Locations
United States, California
Santa Monica, California, United States
United States, Michigan
Ann Arbor, Michigan, United States
Sponsors and Collaborators
ZIOPHARM
Investigators
Study Director: Jonathan Lewis, MD, PhD ZIOPHARM Oncology, Inc
  More Information

No publications provided

Responsible Party: ZIOPHARM
ClinicalTrials.gov Identifier: NCT00439686     History of Changes
Other Study ID Numbers: IPM2001
Study First Received: February 22, 2007
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013