NCT00421135

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2006

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
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

January 10, 2007

Last Update Submit

September 16, 2009

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

  • toxicities

    6 months

Secondary Outcomes (1)

  • pharmacokinetics

    6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

ZIO-201

Drug: ZIO-201

Interventions

ZIO-201DRUG

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

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic and /or unresectable disease state after previous standard chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Detroit, 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

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

February 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

September 17, 2009

Record last verified: 2009-09

Locations

US(2)