Study of ZIO-101 in Multiple Myeloma - Full Text View

Sponsored by:	ZIOPHARM
Information provided by:	ZIOPHARM
ClinicalTrials.gov Identifier:	NCT00303199

Purpose

The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma

Condition	Intervention	Phase
Multiple Myeloma	Drug: Darinaparsin	Phase I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Arsenic Cancer Multiple Myeloma

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma

Further study details as provided by ZIOPHARM:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Pharmacokinetics of ZIO-101 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	January 2006
Estimated Study Completion Date:	February 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: Experimental	Drug: Darinaparsin IV Darinaparsin give for 5 consecutive days to be repeated every 28 days for up to 6 months

Eligibility

Criteria

Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303199

Locations

United States, Arkansas

Little Rock, Arkansas, United States
United States, California

West Hollywood, California, United States
United States, Florida

Miami, Florida, United States
United States, Maryland

Bethesda, Maryland, United States
United States, New York

New York, New York, United States
United States, Ohio

Cleveland, Ohio, United States
Canada, Alberta

Edmonton, Alberta, Canada
Canada, Ontario

Toronto, Ontario, Canada

Sponsors and Collaborators

ZIOPHARM

More Information

Responsible Party:	ZIOPHARM Oncology, Inc ( Jon Lewis, MD )
Study ID Numbers:	SGL2001
Study First Received:	March 13, 2006
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00303199
Health Authority:	United States: Food and Drug Administration

Keywords provided by ZIOPHARM:

Multiple Myeloma
Arsenic
Cancer study
Failed treatment

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Multiple myeloma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders

Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009