Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT00959959
Status:
COMPLETED
Last Update Posted:
2020-09-04
First Post:
2009-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARMOR1: Study of TOK-001 to Treat 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2009-08-14', 'studyFirstSubmitQcDate': '2009-08-14', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Incidence of adverse events', 'timeFrame': '3 months', 'description': 'Safety will be assessed by incidence of AEs and change from baseline in the following additional safety parameters: clinical laboratory assessments, physical examination, vital signs, and 12 lead electrocardiograms (ECGs)'}], 'secondaryOutcomes': [{'measure': 'Efficacy Measures', 'timeFrame': '3 months', 'description': 'Efficacy will be assessed by evaluation of change in PSA level, changes from baseline in CT/MRI and bone scans, response rate RECIST criteria and additional special laboratories'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CRPC', 'HRPC', 'TOK-001', 'ARMOR', 'ARMOR1', 'ESL', 'Galeterone'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether TOK-001 is safe and shows biological effect in the treatment of castration resistant prostate cancer (CRPC).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form\n* Confirmed cancer of the prostate\n* Progressing disease in spite of androgen ablation therapy\n* Able to swallow multiple capsules\n\nExclusion Criteria:\n\n* Participation in another clinical trial \\< 4 weeks prior to enrollment\n* Metastatic disease with one or more of the following:\n\n * Liver involvement\n * Bone pain associated with confirmed evidence of metastases\n * Non-hepatic visceral involvement\n* The following medications:\n\n * Prior treatment with MDV3100, abiraterone, Provenge or TAK700\n * Prior treatment with ketoconazole\n * Prior treatment with chemotherapy\n * Prior radiation therapy completed ≤ 4 weeks prior to enrollment\n* The following medical conditions:\n\n * Active angina pectoris\n * History of Hepatitis B or Hepatitis C\n * Known HIV infection\n * Ongoing hypertension\n\nNote: There are additional inclusion and exclusion criteria. The clinical site center will determine if you are eligible. If you are not eligible for the trial, site staff will detail the reasons to you.'}, 'identificationModule': {'nctId': 'NCT00959959', 'acronym': 'ARMOR1', 'briefTitle': 'ARMOR1: Study of TOK-001 to Treat Castration Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'LTN PHARMACEUTICALS, INC.'}, 'officialTitle': 'ARMOR1: Phase 1, Open Label, Dose Escalation Trial of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'TOK-200-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '650 mg TOK-001', 'interventionNames': ['Drug: TOK-001']}, {'type': 'EXPERIMENTAL', 'label': '1300 mg TOK-001', 'interventionNames': ['Drug: TOK-001']}, {'type': 'EXPERIMENTAL', 'label': '1950 mg TOK-001', 'interventionNames': ['Drug: TOK-001']}, {'type': 'EXPERIMENTAL', 'label': '975 mg TOK-001', 'interventionNames': ['Drug: TOK-001']}, {'type': 'EXPERIMENTAL', 'label': '975 mg TOK-001, supplement', 'interventionNames': ['Drug: TOK-001']}, {'type': 'EXPERIMENTAL', 'label': '1950 mg TOK-001, split dose', 'interventionNames': ['Drug: TOK-001']}, {'type': 'EXPERIMENTAL', 'label': '2600 mg TOK-001', 'interventionNames': ['Drug: TOK-001']}, {'type': 'EXPERIMENTAL', 'label': '2600 mg TOK-001, split dose', 'interventionNames': ['Drug: TOK-001']}], 'interventions': [{'name': 'TOK-001', 'type': 'DRUG', 'otherNames': ['Dose Group 1'], 'description': '2 capsules (325 mg each), once per day', 'armGroupLabels': ['650 mg TOK-001']}, {'name': 'TOK-001', 'type': 'DRUG', 'otherNames': ['Dose Group 3'], 'description': '4 capsules (325 mg each), once per day', 'armGroupLabels': ['1300 mg TOK-001']}, {'name': 'TOK-001', 'type': 'DRUG', 'otherNames': ['Dose Group 4'], 'description': '6 capsules (325 mg each), once per day', 'armGroupLabels': ['1950 mg TOK-001']}, {'name': 'TOK-001', 'type': 'DRUG', 'otherNames': ['Dose Group 2'], 'description': '3 capsules (325 mg each), once per day', 'armGroupLabels': ['975 mg TOK-001']}, {'name': 'TOK-001', 'type': 'DRUG', 'otherNames': ['Dose Group 5'], 'description': '3 capsules (325 mg each), once per day with supplement', 'armGroupLabels': ['975 mg TOK-001, supplement']}, {'name': 'TOK-001', 'type': 'DRUG', 'otherNames': ['Dose Group 6'], 'description': '6 capsules (325 mg each), split dose (3 capsules with breakfast, 3 capsules with dinner)', 'armGroupLabels': ['1950 mg TOK-001, split dose']}, {'name': 'TOK-001', 'type': 'DRUG', 'otherNames': ['Dose Group 7'], 'description': '8 capsules (325 mg each), once per day', 'armGroupLabels': ['2600 mg TOK-001']}, {'name': 'TOK-001', 'type': 'DRUG', 'otherNames': ['Dose Group 8'], 'description': '8 capsules (325 mg each), split dose (4 capsules with breakfast, 4 capsules with dinner)', 'armGroupLabels': ['2600 mg TOK-001, split dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', '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': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada & US Oncology Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'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': '98136', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington/Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'R. B. Montgomery, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'M. E. Taplin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LTN PHARMACEUTICALS, INC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}