Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-04 @ 2:09 PM
Study NCT ID:
NCT00684918
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2008-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)
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': 'C520962', 'term': 'obatoclax'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2013-08-16', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-16', 'studyFirstSubmitDate': '2008-05-23', 'dispFirstSubmitQcDate': '2013-08-16', 'studyFirstSubmitQcDate': '2008-05-27', 'dispFirstPostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AML, obatoclax'], 'conditions': ['AML']}, 'referencesModule': {'references': [{'pmid': '25285531', 'type': 'DERIVED', 'citation': 'Schimmer AD, Raza A, Carter TH, Claxton D, Erba H, DeAngelo DJ, Tallman MS, Goard C, Borthakur G. A multicenter phase I/II study of obatoclax mesylate administered as a 3- or 24-hour infusion in older patients with previously untreated acute myeloid leukemia. PLoS One. 2014 Oct 6;9(10):e108694. doi: 10.1371/journal.pone.0108694. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.', 'detailedDescription': 'The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will randomize 16 patients in to one of two cohorts: 1) patients receiving obatoclax administered by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and safety in the Pilot Schedule portion of the study will then be utilized in the Phase II portion of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed AML\n* No prior chemotherapy for AML (with the exception that the patients enrolled in the Pilot Safety evaluation may have had 1 prior therapy)\n* Age ≥70 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2\n* Patients must have normal organ function as defined below:\n\n 1. Total bilirubin \\< or = 2 mg/dL unless resulting from hemolysis,\n 2. Aspartate transaminase (AST \\[SGOT\\])/alanine transaminase (ALT \\[SGPT\\]) \\< or = 2.5 x institutional ULN\n 3. Creatinine within normal institutional limits, OR creatinine clearance \\> or = 50 mL/min/1.73 meters squared for patients with creatinine levels above institutional ULN\n\nExclusion Criteria:\n\n* Patients who have received or are receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy (with the exception that the patients enrolled in the pilot safety evaluation may have had 1 prior therapy)\n* patients with history of allergic reactions attributed to components of the formulated product (PEG300 and polysorbate 20)\n* patients with history of seizure disorders or central nervous system leukemia\n* patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements\n* Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy'}, 'identificationModule': {'nctId': 'NCT00684918', 'briefTitle': 'Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Open-Label, 2-Stage, Phase II Study of Single-Agent Obatoclax Mesylate Administered For Three Consecutive Days Every 2 Weeks to Older Patients With Previously Untreated Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': 'GEM016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'In the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax.', 'interventionNames': ['Drug: Obatoclax']}], 'interventions': [{'name': 'Obatoclax', 'type': 'DRUG', 'otherNames': ['GX15-070MS'], 'description': 'A 3-hour IV infusion for 3 consecutive days or a 24-hour infusion for 3 consecutive days every 2 weeks for up to 6 cycles.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'The University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center Research Institute', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University - Breslin Cancer Center', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Vincent's Comprehensive Cancer Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Emanuel Hospital & Health Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Cancer Institute-Clinical Trials Office', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Benaroya Research Institute at Virginia Mason', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jean Viallet, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gemin X Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gemin X', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}