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Study of ZIO-101 in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00303199
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : July 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: ZIO-101 (Darinaparsin) Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma
Study Start Date : January 2006
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single Arm 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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Phase II efficacy using EMBT criteria. [ Time Frame: 6 months ]
  3. Safety [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics of ZIO-101 [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00303199     History of Changes
Other Study ID Numbers: SGL2001
First Posted: March 15, 2006    Key Record Dates
Last Update Posted: July 19, 2012
Last Verified: July 2012

Keywords provided by Ziopharm:
Multiple Myeloma
Arsenic
Cancer study
Failed treatment

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases