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: ZIO-101 (Darinaparsin)	Phase I Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Arsenic Cancer Multiple Myeloma

U.S. FDA Resources

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 ]

Enrollment:	35
Study Start Date:	January 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: Experimental	Drug: ZIO-101 (Darinaparsin) IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

No publications provided

Responsible Party:	ZIOPHARM Oncology, Inc ( Jon Lewis, MD )
Study ID Numbers:	SGL2001
Study First Received:	March 13, 2006
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00303199 History of Changes
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
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 by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on September 02, 2009