Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-19 @ 3:41 AM
Study NCT ID:
NCT00397293
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2006-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028178', 'term': 'gossypol acetic acid'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'dispFirstSubmitDate': '2010-08-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-20', 'studyFirstSubmitDate': '2006-11-07', 'dispFirstSubmitQcDate': '2010-08-12', 'studyFirstSubmitQcDate': '2006-11-07', 'dispFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events.', 'timeFrame': '13 months'}], 'secondaryOutcomes': [{'measure': 'complete or partial remission of disease', 'timeFrame': '16 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AT101', 'AT-101', 'cancer', 'lung', 'small-cell', 'topotecan'], 'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer', 'detailedDescription': 'Further Study Details provided by Ascenta:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible.\n* Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan\n* All patients must have measurable disease.\n* Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.\n* ECOG performance status 0-1\n* Adequate hematologic function\n* Adequate liver and renal function\n* Ability to swallow oral medication\n\nExclusion Criteria:\n\n* Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study.\n* Prior chemotherapy regimen containing irinotecan.\n* Active secondary malignancy.\n* Unstable or progressive brain metastases.\n* Prior history of radiation therapy to \\> 25% of the bone marrow.\n* Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.\n* Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).'}, 'identificationModule': {'nctId': 'NCT00397293', 'briefTitle': 'Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascenta Therapeutics'}, 'officialTitle': 'An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy', 'orgStudyIdInfo': {'id': 'AT-101-CS-101'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AT-101', 'type': 'DRUG', 'description': '40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.'}, {'name': 'topotecan', 'type': 'DRUG', 'description': '40 mg of AT-101 (by mouth) on days 1-5 of each 21 day cycle with topotecan 1.25 mg/m2, IV (in the vein) on days 1-5 of each 21 day cycle for approx. 4 cycles or until progression or unacceptable toxicity develops.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Lake City', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.18968, 'lon': -82.63929}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Hilton Head Island', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.19382, 'lon': -80.73816}}, {'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}, {'city': 'Russia', 'state': 'Russia', 'country': 'Russia', 'facility': 'Research Center (16)'}, {'city': 'Ukraine', 'state': 'Ukraine', 'country': 'Ukraine', 'facility': 'Research Centers (8)'}], 'overallOfficials': [{'name': 'Lance Leopold, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ascenta Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascenta Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Janet Maleski, Associate Director, Clinical Development', 'oldOrganization': 'Ascenta Therapeutics, Inc.'}}}}