Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 7:05 PM
Study NCT ID:
NCT00544960
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2007-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'dispFirstSubmitDate': '2010-08-12', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-24', 'studyFirstSubmitDate': '2007-10-12', 'dispFirstSubmitQcDate': '2010-08-12', 'studyFirstSubmitQcDate': '2007-10-12', 'dispFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of disease remission', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'number of participants with adverse events', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AT101', 'AT-101', 'cancer', 'lung', 'non-small cell', 'docetaxel', 'bcl'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-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 Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).\n* Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.\n* All patients must have measurable disease.\n* No unstable or progressive brain metastases.\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* Prior chemotherapy regimen containing docetaxel.\n* Active secondary malignancy.\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': 'NCT00544960', 'briefTitle': 'A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascenta Therapeutics'}, 'officialTitle': 'A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'AT-101-CS-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AT-101 and docetaxel', 'interventionNames': ['Drug: AT-101 and docetaxel']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo and docetaxel', 'interventionNames': ['Drug: placebo and docetaxel']}], 'interventions': [{'name': 'AT-101 and docetaxel', 'type': 'DRUG', 'description': 'AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops', 'armGroupLabels': ['1']}, {'name': 'placebo and docetaxel', 'type': 'DRUG', 'description': 'placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Kaliningrad', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 54.70639, 'lon': 20.51102}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Sites (4)', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Stavropol', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'city': 'Voronezh', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Luhansk', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 48.56814, 'lon': 39.30553}}, {'city': 'Uzhhorod', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}, {'city': 'Zaporizhzhya', 'country': 'Ukraine', 'facility': 'Research Site', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}], 'overallOfficials': [{'name': 'Lance Leopold, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ascenta Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascenta Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Brian Wood, Associate Director, Clinical Development', 'oldOrganization': 'Ascenta Therapeutics'}}}}