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: January 29, 2014
Last verified: January 2014
  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:


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: 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

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
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, see Learn About Clinical Studies.

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: January 29, 2014
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 September 22, 2014