Back to resultsStudy of ZIO-101 in Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ZIO-101 (Darinaparsin)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Arsenic, Cancer study, Failed treatment
Eligibility Criteria
Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
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
Phase II efficacy using EMBT criteria.
Safety
Secondary Outcome Measures
Pharmacokinetics of ZIO-101
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00303199
Brief Title
Study of ZIO-101 in Multiple Myeloma
Official Title
A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alaunos Therapeutics
4. Oversight
5. Study Description
Brief Summary
The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Arsenic, Cancer study, Failed treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZIO-101 (Darinaparsin)
Other Intervention Name(s)
ZIO-101
Intervention Description
IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months
Primary Outcome Measure Information:
Title
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
Title
Phase II efficacy using EMBT criteria.
Time Frame
6 months
Title
Safety
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics of ZIO-101
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
West Hollywood
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
New York
State/Province
New York
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Edmonton
State/Province
Alberta
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of ZIO-101 in Multiple Myeloma
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