A Protocol for the Safety and Tolerance of Intravenous Is... | NCT00421135

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

NCT00421135

Sponsor

Alaunos Therapeutics

Status

Completed

Last Update Posted

Sep 17, 2009Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Advanced Cancer

Interventions

ZIO-201

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Jan 10, 2007

First Submission Date that Met QC Criteria

Jan 10, 2007

First Posted Date

Jan 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2009

Last Update Posted Date

Sep 17, 2009Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	ZIO-201	Drug: ZIO-201

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZIO-201	Drug	ZIO-201 as a single dose given once every 21 days. This is a dose escalation arm.	Single Arm

Measure	Description	Time Frame
toxicities		6 months

Measure	Description	Time Frame
pharmacokinetics		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastatic and /or unresectable disease state after previous standard chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan Lewis, MD, PhD	ZIOPHARM Oncology, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Santa Monica	California		United States

Intervention Browse Module

MeSH Terms

ID	Term
C542790	palifosfamide lysine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided