Study of ZIO-201 in Advanced Sarcoma

Advanced Sarcoma Clinical Trial

Official title:

A Phase IB/IIA Study of the Saftey and Activity of Intravenous Isophosporamide Mustard (ZIO-201) in Patients With Advanced Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439686
• Other study ID #: IPM2001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 22, 2007
• Last updated: January 29, 2014
• Start date: February 2006
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2013
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older
• Eligibility: Metastatic and /or unresectable disease state after previous standard chemotherapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Sarcoma
• Sarcoma

Intervention

Drug:
• ZIO-201
ZIO-201 given for 3 consecutive days to be repeated every 21 days for up to 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicities		6 months	Yes
Secondary	pharmacokinetics		6 months	No