Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT00460460
Status:
TERMINATED
Last Update Posted:
2011-01-25
First Post:
2007-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568512', 'term': 'N-(3-aminopropyl)-N-(1-(5-benzyl-3-methyl-4-oxo-(1,2)thiazolo(5,4-d)pyrimidin-6-yl)-2-methylpropyl)-4-methylbenzamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'whyStopped': 'Study was terminated due to low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2007-04-12', 'studyFirstSubmitQcDate': '2007-04-12', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Phase I', 'cancer', 'lymphoma', 'leukemia', 'myeloma', 'AML', 'ALL', 'NHL', 'MM'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a weekly basis in these diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with AML, a certain type of ALL, NHL and MM\n* certain types of cancer of the lymph nodes\n* certain types of leukemias (blood cancers)\n* disease has or will fail with other treatments\n* relatively good overall health other than your cancer\n\nExclusion Criteria:\n\n* poor bone marrow function (not producing enough blood cells)\n* serious heart conditions\n* poor liver or kidney function'}, 'identificationModule': {'nctId': 'NCT00460460', 'briefTitle': 'Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open-label, Dose Escalation Study to Assess the Safety, Tolerability & Pharmacokinetics of AZD4877 Administered Once Weekly in Adult Patients With Recurrent or Refractory AML, PH Negative ALL, NHL or MN', 'orgStudyIdInfo': {'id': 'D2782C00002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AZD4877', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Judith Ochs, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}