Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT00286793
Status:
COMPLETED
Last Update Posted:
2011-06-29
First Post:
2006-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028178', 'term': 'gossypol acetic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'dispFirstSubmitDate': '2011-06-27', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-27', 'studyFirstSubmitDate': '2006-02-03', 'dispFirstSubmitQcDate': '2011-06-27', 'studyFirstSubmitQcDate': '2006-02-03', 'dispFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of AT-101 in combination with docetaxel and prednisone', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Preliminary efficacy of AT-101 in combination with docetaxel and prednisone', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['at-101', 'at101', 'cancer', 'hormone refractory', 'prostate', 'docetaxel', 'prednisone'], 'conditions': ['Prostate 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 docetaxel and prednisone in men with hormone-refractory prostate cancer that are either chemotherapy naive or have received and progressed on a docetaxel containing regimen,'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Rising prostate specific antigen (PSA) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy.\n2. Patients must have metastatic disease by bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI).\n3. ECOG performance status 0 or 1\n4. Adequate hematologic function\n5. Adequate liver and renal function\n6. Able to swallow and retain oral medication.\n7. Patients enrolled into Cohort B must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising PSA, progression of disease per RECIST, or \\>2 new lesions on bone scan.\n8. Patients enrolled into Cohort B must have received at least two cycles of docetaxel. Minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.\n9. At least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.\n\nExclusion Criteria:\n\n1. Patients enrolled into Cohort A must not have received prior chemotherapy for HRPC.\n2. Known history of or clinical evidence of central nervous system (CNS) metastases.\n3. Active secondary malignancy or history of other malignancy within the last 5 years.\n4. Prior history of radiation therapy to \\> 25% of the bone marrow\n5. Peripheral neuropathy of \\> Grade 2\n6. Uncontrolled concurrent illness\n7. Failure to recover fully, as judged by the investigator, from prior surgical procedures.\n8. Concurrent anti-cancer therapy other than docetaxel and prednisone.\n9. Patients must not be receiving concurrent anti-androgen hormonal therapy for HRPC (LHRH therapies are acceptable to maintain castrate levels of testosterone)'}, 'identificationModule': {'nctId': 'NCT00286793', 'briefTitle': 'Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascenta Therapeutics'}, 'officialTitle': 'An Open-label, Multicenter, Phase I/II Study of AT-101 in Combination With Docetaxel and Prednisone in Men With Hormone Refractory Prostate Cancer (HRPC)', 'orgStudyIdInfo': {'id': 'AT-101-CS-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIngle Arm Study of AT-101 in combination with Docetaxel', 'interventionNames': ['Drug: AT-101']}], 'interventions': [{'name': 'AT-101', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['SIngle Arm Study of AT-101 in combination with Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Fort Meyers', 'state': 'Florida', 'country': 'United States'}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'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}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Richardson', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}], 'overallOfficials': [{'name': 'Lance Leopold, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ascenta Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascenta Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kimberli Brill, Associate Director, Clinical Development', 'oldOrganization': 'Ascenta Therapeutics'}}}}