Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT00407303
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2006-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520962', 'term': 'obatoclax'}, {'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2013-08-16', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2006-12-01', 'dispFirstSubmitQcDate': '2013-08-16', 'studyFirstSubmitQcDate': '2006-12-04', 'dispFirstPostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile', 'timeFrame': '4 weeks to 2 years'}], 'secondaryOutcomes': [{'measure': 'Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements', 'timeFrame': '4 weeks to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mantle-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.', 'detailedDescription': "This is a multi-center, open-label, Phase I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological confirmation of Mantle Cell Lymphoma (ML)\n* Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy\n* Must have normal organ function\n* Must have the ability to understand and willingness to sign a written informed consent form\n\nExclusion Criteria:\n\n* No other agents or therapies administered with the intent to treat malignancy\n* Patients with prior exposure to obatoclax\n* Uncontrolled, intercurrent illness\n* Pregnant women and women who are breast feeding'}, 'identificationModule': {'nctId': 'NCT00407303', 'briefTitle': 'Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)', 'orgStudyIdInfo': {'id': 'GEM012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '30mg obatoclax, 1.0mg/m2 bortezomib', 'interventionNames': ['Drug: Obatoclax mesylate', 'Drug: Bortezomib']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'obatoclax 30 mg, bortezomib 1.3 mg/m2', 'interventionNames': ['Drug: Obatoclax mesylate', 'Drug: Bortezomib']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Obatoclax 45 mg, Bortezomib 1.3 mg/m2', 'interventionNames': ['Drug: Obatoclax mesylate', 'Drug: Bortezomib']}], 'interventions': [{'name': 'Obatoclax mesylate', 'type': 'DRUG', 'otherNames': ['(GX15-070MS)'], 'description': '30 mg, 45 mg', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Bortezomib', 'type': 'DRUG', 'description': '1.0mg/m2, 1.3 mg/m2', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NW Georgia Oncology Centers', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Jean Viallet, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gemin X, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gemin X', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}