NCT00439686

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

2.3 years

First QC Date

February 22, 2007

Last Update Submit

January 29, 2014

Conditions

Advanced Sarcoma

Outcome Measures

Primary Outcomes (1)

  • toxicities

    6 months

Secondary Outcomes (1)

  • pharmacokinetics

    6 months

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: ZIO-201

Interventions

ZIO-201DRUG

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

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Metastatic and /or unresectable disease state after previous standard chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

MeSH Terms

Interventions

palifosfamide lysine

Study Officials

  • Jonathan Lewis, MD, PhD

    ZIOPHARM Oncology, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 26, 2007

Study Start

February 1, 2006

Primary Completion

June 1, 2008

Study Completion

December 1, 2013

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

US(2)