Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 3:31 PM
Study NCT ID:
NCT00777959
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2008-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Colombia', 'Denmark', 'Finland', 'Italy', 'Netherlands', 'Peru', 'Poland', 'Spain', 'Sweden', 'United Kingdom', 'United States']}, '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': 'C515074', 'term': 'ridaforolimus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2008-10-21', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30% Prostate specific antigen (PSA) decline within 12 weeks', 'timeFrame': '12 weeks'}, {'measure': 'Number of dose limiting toxicities (DLTs)', 'timeFrame': 'Day 1 to Day 35'}], 'secondaryOutcomes': [{'measure': 'Prostate specific antigen (PSA) response rate', 'timeFrame': '12 weeks'}, {'measure': 'Number of patients with progression free survival (PFS)', 'timeFrame': '12 weeks'}, {'measure': 'Time to prostate specific antigen (PSA) progression', 'timeFrame': '12 weeks'}, {'measure': 'Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus', 'timeFrame': '30 Minutes to 24 hour postdose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '23921574', 'type': 'RESULT', 'citation': 'Meulenbeld HJ, de Bono JS, Tagawa ST, Whang YE, Li X, Heath KH, Zandvliet AS, Ebbinghaus SW, Hudes GR, de Wit R. Tolerability, safety and pharmacokinetics of ridaforolimus in combination with bicalutamide in patients with asymptomatic, metastatic castration-resistant prostate cancer (CRPC). Cancer Chemother Pharmacol. 2013 Oct;72(4):909-16. doi: 10.1007/s00280-013-2250-6. Epub 2013 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.', 'detailedDescription': 'Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed adenocarcinomas of the prostate.\n* Evidence of metastatic disease\n* Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan\n* PSA level is greater or equal to 7 ng/ml.\n* ECOG performance status less than or equal to 1\n\nExclusion Criteria :\n\n* Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).\n* Prior chemotherapy for prostate cancer\n* Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.\n* Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer\n* Patient has pain related to prostate cancer that warrants the initiation of chemotherapy'}, 'identificationModule': {'nctId': 'NCT00777959', 'briefTitle': 'Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer', 'orgStudyIdInfo': {'id': '8669-002'}, 'secondaryIdInfos': [{'id': '2008_572'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open Label', 'description': 'ridaforolimus (MK8669)+ bicalutamide', 'interventionNames': ['Drug: open-label ridaforolimus (MK8669)']}, {'type': 'EXPERIMENTAL', 'label': 'Ridaforolimus', 'description': 'ridaforolimus (MK8669)+ bicalutamide', 'interventionNames': ['Drug: ridaforolimus (MK8669)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo + bicalutamide', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'ridaforolimus (MK8669)', 'type': 'DRUG', 'otherNames': ['AP23573'], 'description': 'Three 10 mg tablets administered daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.', 'armGroupLabels': ['Ridaforolimus']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Three tablets of matching placebo to ridaforolimus administered daily for 5 consecutive days each week followed by 2 days without matching placebo and on 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.', 'armGroupLabels': ['Placebo']}, {'name': 'open-label ridaforolimus (MK8669)', 'type': 'DRUG', 'otherNames': ['AP23573'], 'description': 'Single dose of three 10 mg tablets ridaforolimus on Day 1, and 50 mg bicalutamide once daily starting on Day 2. On Day 8, patients will begin taking three 10 mg tablets of ridaforolimus daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide once daily for 7 days each week. Treatment will continue until disease progression.', 'armGroupLabels': ['Open Label']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ariad Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}