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NCT00303199 Clinical Trial

Study of ZIO-101 in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
A Phase I/II Trial of ZIO-101 in Advanced Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00303199
Other study ID # SGL2001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 13, 2006
Last updated July 18, 2012
Start date January 2006
Est. completion date August 2007

Study information
Verified date July 2012
Source Ziopharm
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ZIO-101 (Darinaparsin)
IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ziopharm

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03 6 months Yes
Primary Phase II efficacy using EMBT criteria. 6 months No
Primary Safety 6 months Yes
Secondary Pharmacokinetics of ZIO-101 6 months Yes
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