We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of ZIO-201 in Advanced Sarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00439686
First Posted: February 26, 2007
Last Update Posted: January 31, 2014
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.
Information provided by (Responsible Party):
Ziopharm
  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
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

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • toxicities [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • pharmacokinetics [ Time Frame: 6 months ]

Enrollment: 53
Study Start Date: February 2006
Study Completion Date: December 2013
Primary Completion Date: June 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Metastatic and /or unresectable disease state after previous standard chemotherapy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT00439686     History of Changes
Other Study ID Numbers: IPM2001
First Submitted: February 22, 2007
First Posted: February 26, 2007
Last Update Posted: January 31, 2014
Last Verified: January 2014

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