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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00130702 |
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Date of registration:
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15/08/2005 |
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Primary sponsor: |
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Public title:
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Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
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Scientific title:
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A Phase II Study of Iressa (Gefitinib), in Patients With Relapsed or Refractory Acute Myelogenous Leukemia and in Older Patients With Newly Diagnosed Acute Myelogenous Leukemia |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00130702 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel J DeAngelo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dana-Farber Cancer Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients must have pathologically documented acute myelogenous leukemia and either
not be a candidate for myelosuppressive chemotherapy due to age or comorbid disease;
or have relapsed acute myelogenous leukemia or be refractory to standard therapy and
not likely to require cytoreductive therapy within 30 days.
- ECOG performance status 0, 1 or 2
- Age > 18 years
- Adequate kidney and hepatic function
- Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic
steroid therapy with the exception of hydroxyurea.
- Greater than 2 months following bone marrow or peripheral blood stem cell
transplantation or donor lymphocyte infusion.
Exclusion Criteria:
- Uncontrolled active infection
- Urgent need for cytoreductive chemotherapy, surgery, or radiotherapy
- Current chemotherapy or chemotherapy within the last 4 weeks.
- Pregnancy or nursing mothers
- Infection with HIV
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myelogenous Leukemia, Acute
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Intervention(s)
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Drug: gefitinib
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Primary Outcome(s)
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To determine the response rate of Iressa in patients with acute myelogenous leukemia
[Time Frame: TBD]
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Secondary Outcome(s)
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to determine the biologic activity of Iressa in patients with acute myelogenous leukemia
[Time Frame: 2 years]
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To determine the safety of Iressa in patients with acute myelogenous leukemia
[Time Frame: 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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