Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT01709734
Status:
TERMINATED
Last Update Posted:
2023-03-15
First Post:
2012-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'C500627', 'term': '3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'whyStopped': "Study was terminated prematurely in all investigational study centers upon recommendation from the study's Data Monitoring Committee (DMC).\n\nStudy was stopped due to lack of efficacy.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2012-10-16', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmation of recommended dose and patient population for Part 2 of the study.', 'timeFrame': '3 months', 'description': 'Confirmation of recommended dose and patient population for Part 2 of the study.'}, {'measure': 'Assessment of efficacy by means of PSA response.', 'timeFrame': '3 months', 'description': 'Assessment of efficacy by means of PSA response.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer CRPC'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.', 'detailedDescription': 'This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and target patient population and Part 2 will be expansion of the dose and patient population selected in Part 1. For eligible patients, there will be an optional extension dosing following the completion of Part 1 or Part 2 of the trial.\n\nObtaining of informed consent and screening may be performed up to 28 days prior to enrollment. Each patient will be able to receive his specified regimen for 3 consecutive cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit assessments will be used to determine outcome and dosing may continue up to an additional 2 weeks until the results of all assessments are obtained. Eligible patients may continue treatment in an optional extension period following the completion of the primary parts of this trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically or cytologically confirmed adenocarcinoma of the prostate\n2. Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL\n3. Demonstration of progression while on androgen blockade\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status \\<2\n\nExclusion Criteria:\n\n1. Depending upon patient prior treatment the following apply:\n\n * Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole\\*, enzalutamide, or galeterone) - Treatment naïve only\n * Prior treatment with CYP17 inhibitors (e.g. TAK-700, ketoconazole\\*) or AR antagonists (e.g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory only\n * Prior treatment with CYP17 inhibitors (e.g. abiraterone, TAK-700, ketoconazole\\*) or AR antagonists (e.g. ARN -509) or galeterone - enzalutamide refractory only\n2. Prior chemotherapy (unless allowed for some study arms)\n3. Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment\n4. Prior use of any chronic systemic glucocorticoids .\n5. Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment\n6. Prior treatment with Alpharadin® (Xofigo®)\n7. Treatment with anti arrhythmia therapy for ventricular arrhythmia \\< 4 weeks prior to enrollment\n8. Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) \\< 4 weeks prior to enrollment\n9. Severe systemic diseases or active uncontrolled illnesses.\n10. Abnormal heart function\n11. Liver metastases\n12. Brain metastases (unless stable disease \\>3 mos. by scan without additional CNS-directed therapy)\n13. The patient has known allergy to any of the treatment components\n14. Any physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient's ability to comply with the trial procedures\n15. History of excessive alcohol consumption\n16. Use of any substance known to cause AME"}, 'identificationModule': {'nctId': 'NCT01709734', 'acronym': 'ARMOR2', 'briefTitle': 'A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'LTN PHARMACEUTICALS, INC.'}, 'officialTitle': 'ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'TOK-200-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Confirmation', 'description': 'Dose A - galeterone tablets once daily PO for three months + extension\n\nDose B - galeterone tablets once daily PO for three months + extension\n\nDose C - galeterone tablets once daily PO for three months + extension', 'interventionNames': ['Drug: galeterone']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion', 'description': 'Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension', 'interventionNames': ['Drug: galeterone']}], 'interventions': [{'name': 'galeterone', 'type': 'DRUG', 'otherNames': ['TOK-001'], 'armGroupLabels': ['Dose Confirmation', 'Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-7384', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA David Geffen School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92404', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'San Bernardino Urological Associates', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Raton Regional Hospital, Lynn Cancer Institute', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Cancer Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'AAHS Research Institute', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Urology Cancer Center and GU Research Network', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08724', 'city': 'Brick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Coastal Urology Associates', 'geoPoint': {'lat': 40.05928, 'lon': -74.13708}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Premier Urology Associates, LLC', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Center Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28025', 'city': 'Concord', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Clinical Trials', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System University Medical Center', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Urologic Research Center', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology Clinics of North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98136', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington/Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Bruce Montgomery, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington Seattle Cancer Care Alliance'}, {'name': 'Mary Ellen Taplin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LTN PHARMACEUTICALS, INC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}