Study of ZIO-101 in Multiple Myeloma

July 18, 2012 updated by: Alaunos Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Ontario
      • Toronto, Ontario, Canada
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • West Hollywood, California, United States
    • Florida
      • Miami, Florida, United States
    • Maryland
      • Bethesda, Maryland, United States
    • New York
      • New York, New York, United States
    • Ohio
      • Cleveland, Ohio, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • ZIO-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: 6 months
6 months
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
6 months
Phase II efficacy using EMBT criteria.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of ZIO-101
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaunos Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 14, 2006

First Posted (Estimate)

March 15, 2006

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGL2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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