Study of ZIO-101 in Multiple Myeloma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ZIOPHARM

ClinicalTrials.gov Identifier:

NCT00303199

First received: March 13, 2006

Last updated: July 18, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 13, 2006
Last Updated Date	July 18, 2012
Start Date ^ICMJE	January 2006
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 26, 2007)	Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] Phase II efficacy using EMBT criteria. [ Time Frame: 6 months ] [ Designated as safety issue: No ] Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: March 14, 2006)	Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03 Phase II efficacy using EMBT criteria. Safety
Change History	Complete list of historical versions of study NCT00303199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 26, 2007)	Pharmacokinetics of ZIO-101 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 14, 2006)	Pharmacokinetics of ZIO-101
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of ZIO-101 in Multiple Myeloma
Official Title ^ICMJE	A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma
Brief Summary	The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Multiple Myeloma
Intervention ^ICMJE	Drug: ZIO-101 (Darinaparsin) IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months Other Name: ZIO-101
Study Arm (s)	Experimental: Single Arm Intervention: Drug: ZIO-101 (Darinaparsin)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	35
Completion Date	August 2007
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00303199
Other Study ID Numbers ^ICMJE	SGL2001
Has Data Monitoring Committee	Not Provided
Responsible Party	ZIOPHARM
Study Sponsor ^ICMJE	ZIOPHARM
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ZIOPHARM
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top