Phase II Study of AS1411 Combined With Cytarabine to Trea... | NCT00512083

Studies
Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

NCT00512083

Sponsor

Antisoma Research

Status

Completed

Last Update Posted

Sep 25, 2009Estimated

Enrollment

70Estimated

Phase

Phase 2

Conditions

Leukemia, Myeloid

Interventions

AS1411

Countries

United States
New Zealand

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

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Not provided

First Submitted Date

Aug 6, 2007

First Submission Date that Met QC Criteria

Aug 6, 2007

First Posted Date

Aug 7, 2007Estimated

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

Sep 24, 2009

Last Update Posted Date

Sep 25, 2009Estimated

Description Module

Brief Summary

The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AS1411	Drug	AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary refractory or relapsed AML
confirmed diagnosis of AML (de novo or secondary) as defined by WHO classification (Vardiman 2002)
aged at least 18 years

Exclusion Criteria:

initial diagnosis of acute promyelocytic leukemia as defined by French-American-British criteria (Bennett 1976)
patient in blast crisis stage of chronic myeloid leukemia
received high-dose cytarabine (total cumulative dose of >6g/m sq)in last 6 months
interval of <6 months between first onset of last complete remission and current relapse
those with primary refractory leukemia who have received more than three previous induction cycles
relapsed patients who have received more than three previous treatment regimens

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Medical Center		Los Angeles	California	90095	United States
Univeristy of Colorado Health Cancer Center

Condition Browse Module

MeSH Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D000208	Acute Disease

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided