Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00405951
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2006-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520962', 'term': 'obatoclax'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2013-08-16', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2006-11-30', 'dispFirstSubmitQcDate': '2013-08-16', 'studyFirstSubmitQcDate': '2006-11-30', 'dispFirstPostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RECIST criteria with at least one lesion equal to or greater than 2.0cm using conventional technique or equal to greater than 1.0cm with spiral comupted tomography (CT) scan in a single dimension', 'timeFrame': '18 months', 'description': 'Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.'}], 'secondaryOutcomes': [{'measure': 'Peripheral blood counts; Bone marrow aspirates and biopsies', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': "Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic 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.\n\nThis is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological confirmation of Non-Small Cell Lung Cancer (NSCLC)\n* Must have been previously treated with a single platinum-based chemotherapy regimen and shown evidence of disease progression; no further limitations\n* Must have normal organ function\n* Must be willing to submit to blood sampling for planned PK and PD analysis\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 or docetaxel\n* Uncontrolled, intercurrent illness\n* Pregnant women and women who are breast feeding'}, 'identificationModule': {'nctId': 'NCT00405951', 'briefTitle': 'Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered Every 3 Weeks in Combination With Docetaxel to Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'GEM010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obatoclax Mesylate + Docetaxel', 'description': 'Obatoclax Mesylate 250mL in combination with Docetaxel', 'interventionNames': ['Drug: Obatoclax mesylate 250 ml', 'Drug: Docetaxel']}], 'interventions': [{'name': 'Obatoclax mesylate 250 ml', 'type': 'DRUG', 'armGroupLabels': ['Obatoclax Mesylate + Docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'armGroupLabels': ['Obatoclax Mesylate + Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic College of Medicine', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Tower Oncology', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Research Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Cancer Center', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}], 'overallOfficials': [{'name': 'Jean Viallet, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gemin X Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gemin X', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}