Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-22 @ 3:56 PM
Study NCT ID:
NCT01046916
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen
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': 'C571806', 'term': 'orteronel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'dispFirstSubmitDate': '2016-03-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-04', 'studyFirstSubmitDate': '2010-01-11', 'dispFirstSubmitQcDate': '2016-03-04', 'studyFirstSubmitQcDate': '2010-01-11', 'dispFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months', 'timeFrame': '3 and 6 months'}, {'measure': 'To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment', 'timeFrame': '6 months'}, {'measure': 'To determine time to PSA progression, time to metastases, and duration of progression-free survival', 'timeFrame': 'Evidence of PSA or disease progression'}, {'measure': 'To monitor changes in endocrine markers', 'timeFrame': 'Evidence of PSA or disease progression'}, {'measure': 'To evaluate the safety of TAK-700', 'timeFrame': 'Evidence of PSA or disease progression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '24965748', 'type': 'DERIVED', 'citation': 'Hussain M, Corn PG, Michaelson MD, Hammers HJ, Alumkal JJ, Ryan CJ, Bruce JY, Moran S, Lee SY, Lin HM, George DJ; Prostate Cancer Clinical Trials Consortium, a program of the Department of Defense Prostate Cancer Research Program and the Prostate Cancer Foundation. Phase II study of single-agent orteronel (TAK-700) in patients with nonmetastatic castration-resistant prostate cancer and rising prostate-specific antigen. Clin Cancer Res. 2014 Aug 15;20(16):4218-27. doi: 10.1158/1078-0432.CCR-14-0356. Epub 2014 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEach patient must meet all of the following inclusion criteria:\n\n* Male patients 18 years or older\n* Eastern Cooperative Oncology Group performance status 0-2\n* Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse.\n* Voluntary written consent\n* Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone\n* Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to 8 months OR baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than 8 months\n* Has undergone orchiectomy or will continue receiving GnRH analogue therapy\n* Meet screening laboratory values as specified in protocol\n\nExclusion Criteria:\n\nPatients meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n* Known hypersensitivity to TAK-700 or related compounds\n* Received any of the following within 30 days prior to the first dose of TAK-700: any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; OR chronic therapy with corticosteroids\n* Received prior therapy with aminoglutethimide or ketoconazole\n* Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug\n* Received prior chemotherapy for prostate cancer\n* Current bladder neck outlet obstruction caused by prostate cancer, current spinal cord compression, or current bilateral hydronephrosis\n* Symptoms that investigator deems related to prostate cancer\n* Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected\n* History of adrenal insufficiency\n* Uncontrolled cardiovascular condition\n* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C\n* Unwilling or unable to comply with protocol\n* Major surgery or serious infection within 14 days of first dose of TAK-700\n* Life-threatening illness unrelated to cancer\n* Uncontrolled nausea, vomiting or diarrhea\n* Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700"}, 'identificationModule': {'nctId': 'NCT01046916', 'briefTitle': 'Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Millennium Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2 Multicenter Open-label Study Evaluating the Safety and Efficacy of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer (CRPC) and a Rising Prostate-specific Antigen (PSA)', 'orgStudyIdInfo': {'id': 'C21001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAK-700', 'interventionNames': ['Drug: TAK-700']}], 'interventions': [{'name': 'TAK-700', 'type': 'DRUG', 'description': 'TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule', 'armGroupLabels': ['TAK-700']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospitals and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Millennium Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}