Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT01018069
Status:
TERMINATED
Last Update Posted:
2011-07-13
First Post:
2009-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AEG35156 in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015473', 'term': 'Leukemia, Promyelocytic, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C498209', 'term': 'AEG 35156'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Failed to reach endpoints', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-12', 'studyFirstSubmitDate': '2009-11-19', 'studyFirstSubmitQcDate': '2009-11-20', 'lastUpdatePostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if AEG35156 can enhance the CR and CR with incomplete platelet recovery (CRp) rate and duration of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To determine if AEG35156 can enhance overall survival, is safe and measured (Pharmacokinetic) following high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute', 'myeloid', 'leukemia', 'antisense', 'chemotherapy', 'idarubicin', 'cytarabine', 'Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen.'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'To determine if AEG35156 can enhance the combined complete remission (CR) and CR with incomplete platelet recovery (CRp) rate of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either \\> 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb \\< 10 g/dL, or platelets \\< 100 x 109/L, or neutrophil count \\< 1.0 x 109/L).\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.\n* Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.\n* Patients must have adequate organ and immune function as indicated by the following laboratory values:\n\nParameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN\n\n* The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.\n\nExclusion Criteria:\n\n* Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy\n* Patients with a prior history of peripheral neuropathy of grade 2 or higher.\n* Clinical evidence of active CNS leukemic involvement.\n* Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.\n* Current evidence of invasive fungal infection (blood or tissue culture).\n* Current evidence of an active second malignancy except for non-melanoma skin cancer.\n* Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.\n* Neurological or psychiatric disorders that would interfere with consent or study follow-up.\n* Known or suspected intolerance or hypersensitivity to the study drugs \\[or closely related compounds\\] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.\n* History of alcohol or other substance abuse within the last year.\n* Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.\n* Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded."}, 'identificationModule': {'nctId': 'NCT01018069', 'briefTitle': 'AEG35156 in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aegera Therapeutics'}, 'officialTitle': 'An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen', 'orgStudyIdInfo': {'id': 'AEG35156-206'}, 'secondaryIdInfos': [{'id': '2009-013669-25', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AEG35156', 'description': 'Patient receive AEG35156 prior to chemotherapy', 'interventionNames': ['Drug: AEG35156']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Patients receive chemotherapy only', 'interventionNames': ['Drug: AEG35156']}], 'interventions': [{'name': 'AEG35156', 'type': 'DRUG', 'description': '2 hr infusion of 650 mg of AEG35156 on days 1, 2, 3 and 8. Idarubicin 12 mg/m2 over 30 minutes daily on each of days 4, 5 and 6. The dose of cytarabine will be 1.5 g/m2 daily by continuous infusion x 4 days (days 4-7) in patients under age 65 and x 3 days (days 4-6) in patients age 65 and above.', 'armGroupLabels': ['AEG35156', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Blood & Marrow Transplant Program', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Med School, div. Oncology & Hematology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '77303', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76502', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Research Institute of Scott & White Hospital', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Charles Lemoyne', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Sacre Coeur', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '09113', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Klinikum Chemnitz gGmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '47166', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'St. Johannes Hospital', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitatsklinimum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitatsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '24116', 'city': 'Kiel', 'country': 'Germany', 'facility': '2. Medizinische Klinik und Poliklinik im Stadtischen Krankenhaus Kile GmgH', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'III. Medizinische Klinik und Poliklinik der Johannes Gutenberg-Universitat', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '48129', 'city': 'Münster', 'country': 'Germany', 'facility': 'Medizinische Klinik a Hamatologie und Onkologie', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert Boasch Krankenhaus Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Aaron Schimmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aegera Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jacques Jolivet', 'oldOrganization': 'Aegera Therapeutics Inc.'}}}}