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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. Identifier: NCT00303199
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : July 19, 2012
Information provided by (Responsible Party):

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

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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
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

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 ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00303199

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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

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Responsible Party: Ziopharm 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
Cancer study
Failed treatment
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases