Study of ZIO-101 in Multiple Myeloma | NCT00303199

Studies
Study of ZIO-101 in Multiple Myeloma

NCT00303199

Sponsor

Alaunos Therapeutics

Status

Completed

Last Update Posted

Jul 19, 2012Estimated

Enrollment

35Actual

Phase

Phase 1Phase 2

Conditions

Multiple Myeloma

Interventions

ZIO-101 (Darinaparsin)

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Mar 13, 2006

First Submission Date that Met QC Criteria

Mar 14, 2006

First Posted Date

Mar 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2012

Last Update Posted Date

Jul 19, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental		Drug: ZIO-101 (Darinaparsin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZIO-101 (Darinaparsin)	Drug	IV zio-101 (Darinaparsin) give for 5 consecutive days to be repeated every 28 days for up to 6 months	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pharmacokinetics of ZIO-101		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C515055	darinaparsin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Little Rock	Arkansas		United States