Study of ZIO-201 in Advanced Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439686
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : January 31, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Advanced Sarcoma Drug: ZIO-201 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2006
Primary Completion Date : June 2008
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm Drug: ZIO-201
ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months

Primary Outcome Measures :
  1. toxicities [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. pharmacokinetics [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Metastatic and /or unresectable disease state after previous standard chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439686

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

Responsible Party: Ziopharm Identifier: NCT00439686     History of Changes
Other Study ID Numbers: IPM2001
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents