We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of ZIO-101 in Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00303199
First Posted: March 15, 2006
Last Update Posted: July 19, 2012
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.
Information provided by (Responsible Party):
Ziopharm
  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 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]
  • Phase II efficacy using EMBT criteria. [ Time Frame: 6 months ]
  • Safety [ Time Frame: 6 months ]

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

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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: March 13, 2006
First Posted: March 15, 2006
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