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NCT00421135 Clinical Trial

A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:
A Protocol for the Safety and Tolerance of Intravenous Isophosphoramide Mustard (IPM) in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00421135
Other study ID # IPM1001
Secondary ID
Status Completed
Phase Phase 1
First received January 10, 2007
Last updated September 16, 2009
Start date February 2006
Est. completion date October 2007

Study information
Verified date September 2009
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 cancer.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Intervention

Drug:
• ZIO-201
ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.

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
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