Study of ZIO-101 in Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: ZIO-101 (Darinaparsin)

• Registration Number: NCT00303199
• Lead Sponsor: Alaunos Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-13
• Study First Submitted QC: 2006-03-14
• Study First Posted: 2006-03-15
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-18
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	ZIO-101 (Darinaparsin)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacokinetics of ZIO-101	6 months