Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00130702
Status:
COMPLETED
Last Update Posted:
2014-05-01
First Post:
2005-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-29', 'studyFirstSubmitDate': '2005-08-15', 'studyFirstSubmitQcDate': '2005-08-15', 'lastUpdatePostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the response rate of Iressa in patients with acute myelogenous leukemia'}], 'secondaryOutcomes': [{'measure': 'To determine the safety of Iressa in patients with acute myelogenous leukemia', 'timeFrame': '2 years'}, {'measure': 'to determine the biologic activity of Iressa in patients with acute myelogenous leukemia', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AML', 'acute myelogenous leukemia', 'gefitinib', 'Iressa'], 'conditions': ['Myelogenous Leukemia, Acute']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.', 'detailedDescription': 'Patients will receive Iressa daily until either disease progression or intolerable toxicity develops. On Day 1 of treatment, a physical exam and bloodwork will be performed. Once weekly for the first 8 weeks, a physical exam and complete blood count with differential will be performed.\n\nFor the first year, a physical exam, bloodwork will be performed monthly. Bone marrow biopsies will be performed after the first month of therapy and then every 3 months for the first year. After the first year a physical exam, bloodwork will be performed every 3 months and bone marrow biopsies every 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* ECOG performance status 0, 1 or 2\n* Age \\> 18 years\n* Adequate kidney and hepatic function\n* Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea.\n* Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or donor lymphocyte infusion.\n\nExclusion Criteria:\n\n* Uncontrolled active infection\n* Urgent need for cytoreductive chemotherapy, surgery, or radiotherapy\n* Current chemotherapy or chemotherapy within the last 4 weeks.\n* Pregnancy or nursing mothers\n* Infection with HIV'}, 'identificationModule': {'nctId': 'NCT00130702', 'briefTitle': 'Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '05-086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gefitinib (Iressa)', 'description': 'All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.', 'interventionNames': ['Drug: gefitinib']}], 'interventions': [{'name': 'gefitinib', 'type': 'DRUG', 'otherNames': ['Iressa'], 'description': 'gefitinib (Iressa) at a dose of 750 mg, once per day', 'armGroupLabels': ['Gefitinib (Iressa)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Daniel J DeAngelo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': "Boston Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daniel J. DeAngelo, MD, PhD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}