NCT00303199

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

1.6 years

First QC Date

March 13, 2006

Last Update Submit

July 18, 2012

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaArsenicCancer studyFailed treatment

Outcome Measures

Primary Outcomes (3)

  • Phase I: toxicity defined in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) 12/12/03

    6 months

  • Phase II efficacy using EMBT criteria.

    6 months

  • Safety

    6 months

Secondary Outcomes (1)

  • Pharmacokinetics of ZIO-101

    6 months

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: ZIO-101 (Darinaparsin)

Interventions

ZIO-101 (Darinaparsin)DRUG

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

Also known as: ZIO-101
Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Subjects with multiple myeloma who have received at least two prior therapies and currently require therapy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

West Hollywood, California, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Bethesda, Maryland, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

darinaparsin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 15, 2006

Study Start

January 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

July 19, 2012

Record last verified: 2012-07

Locations

CA(2)US(6)