Study of ZIO-201 in Advanced Sarcoma

This study is ongoing, but not recruiting participants.

First Received: February 22, 2007 Last Updated: August 22, 2008 History of Changes

Sponsored by:	ZIOPHARM
Information provided by:	ZIOPHARM
ClinicalTrials.gov Identifier:	NCT00439686

Purpose

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

Condition	Intervention	Phase
Advanced Sarcoma	Drug: ZIO-201	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Soft Tissue Sarcoma

Further study details as provided by ZIOPHARM:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	40
Study Start Date:	February 2006
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: Experimental	Drug: ZIO-201 ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months

Eligibility

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

More Information

No publications provided

Responsible Party:	ZIOPHARM Oncology, Inc ( Jon Lewis, Chief Medical Officer )
Study ID Numbers:	IPM2001
Study First Received:	February 22, 2007
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00439686 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Mechlorethamine
Sarcoma

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Sarcoma

ClinicalTrials.gov processed this record on September 10, 2009