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Study of ZIO-101 in Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT00303199
First received: March 13, 2006
Last updated: July 18, 2012
Last verified: July 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
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

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
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, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00303199     History of Changes
Other Study ID Numbers: SGL2001
Study First Received: March 13, 2006
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 19, 2014