Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT01284920
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2011-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
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': 'C540278', 'term': 'enzalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2014-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2011-01-18', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC', 'timeFrame': '3 months during the study', 'description': 'This measure will be assessed on the dose escalation cohorts.'}, {'measure': 'Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)', 'timeFrame': 'Day 85 and end of long term dosing period', 'description': 'This measure will be assessed on the dose expansion cohort'}], 'secondaryOutcomes': [{'measure': 'Prostate Specific Antigen (PSA) Response', 'timeFrame': 'Day 85 and end of long term dosing period'}, {'measure': 'Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG', 'timeFrame': '3 months during the study', 'description': 'This measure will be assessed on the dose expansion cohort.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['docetaxel', 'Response Evaluation Criteria in Solid Tumor (RECIST)', 'PSA level', 'MDV3100'], 'conditions': ['Prostate Cancer', 'Prostate Neoplasms', 'Castration Resistant Prostate Cancer (CRPC)']}, 'referencesModule': {'references': [{'pmid': '26793974', 'type': 'DERIVED', 'citation': 'Akaza H, Uemura H, Tsukamoto T, Ozono S, Ogawa O, Sakai H, Oya M, Namiki M, Fukasawa S, Yamaguchi A, Uemura H, Ohashi Y, Maeda H, Saito A, Takeda K, Naito S. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer. Int J Clin Oncol. 2016 Aug;21(4):773-782. doi: 10.1007/s10147-016-0952-6. Epub 2016 Jan 21.'}], 'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=110', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.', 'detailedDescription': 'This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy\n* Progressive disease after prior androgen deprivation therapy (medical or surgical castration)\n* For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel\n* For Expansion Cohort, the patient must have measurable lesions by RECIST\n\nExclusion Criteria:\n\n* Metastases in the brain\n* History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years\n* Use of bicalutamide within 6 weeks prior to study\n* Radiation therapy within 12 weeks prior to study\n* Evidence of serious drug hypersensitivity'}, 'identificationModule': {'nctId': 'NCT01284920', 'briefTitle': 'A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': '9785-CL-0111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose-escalation cohort-1', 'description': 'MDV3100 low dose arm', 'interventionNames': ['Drug: MDV3100']}, {'type': 'EXPERIMENTAL', 'label': 'dose-escalation cohort-2', 'description': 'MDV3100 middle dose arm', 'interventionNames': ['Drug: MDV3100']}, {'type': 'EXPERIMENTAL', 'label': 'dose-escalation cohort-3', 'description': 'MDV3100 high dose arm', 'interventionNames': ['Drug: MDV3100']}, {'type': 'EXPERIMENTAL', 'label': 'dose-expansion cohort', 'description': 'dose expansion with MDV3100 middle dose', 'interventionNames': ['Drug: MDV3100']}], 'interventions': [{'name': 'MDV3100', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['dose-escalation cohort-1', 'dose-escalation cohort-2', 'dose-escalation cohort-3', 'dose-expansion cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan'}, {'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kanto', 'country': 'Japan'}, {'city': 'Kyusyu', 'country': 'Japan'}, {'city': 'Shikoku', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medivation LLC, a wholly owned subsidiary of Pfizer Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}