Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia
This study has been completed.
Sponsor:
Antisoma Research
Information provided by:
Antisoma Research
ClinicalTrials.gov Identifier:
NCT00512083
First received: August 6, 2007
Last updated: September 24, 2009
Last verified: September 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myeloid |
Drug: AS1411 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia |
Resource links provided by NLM:
Further study details as provided by Antisoma Research:
Primary Outcome Measures:
- The prorportion of patients achieving a completel response (CR) after the first cycle of treatment in each treatment group [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2007 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: AS1411
AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512083
Locations
| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Univeristy of Colorado Health Cancer Center | |
| Aurora, Colorado, United States, 80010 | |
| United States, Indiana | |
| St. Francis Hospital and Health Center | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Kentucky | |
| University of Louisville, James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Missouri | |
| Washington University | |
| St Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Cancer Therapy and Research Center - Institute for Drug development | |
| San Antonio, Texas, United States, 78229 | |
| New Zealand | |
| Christchurch Hospital | |
| Christchurch, New Zealand | |
Sponsors and Collaborators
Antisoma Research
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00512083 History of Changes |
| Other Study ID Numbers: | AS1411-C-201 |
| Study First Received: | August 6, 2007 |
| Last Updated: | September 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Antisoma Research:
|
Leukemia, Myeloid + Acute Disease |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013