Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00808418
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2008-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-31', 'studyFirstSubmitDate': '2008-12-12', 'studyFirstSubmitQcDate': '2008-12-12', 'lastUpdatePostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects', 'timeFrame': 'Jan 2011'}, {'measure': 'To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel', 'timeFrame': 'Jan 2011'}, {'measure': 'To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population', 'timeFrame': 'Jan 2011'}], 'secondaryOutcomes': [{'measure': 'To evaluate anti-tumor activity at the MTD in castration refractory prostate cancer', 'timeFrame': 'Jan 2011'}, {'measure': 'Evaluate OS', 'timeFrame': 'Jan 2011'}, {'measure': 'To characterize the pharmacokinetics of elesclomol metabolites', 'timeFrame': 'Jan 2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate', 'cancer', 'metastatic', 'castration', 'refractory', 'elesclomol', 'sodium', 'docetaxel', 'prednisone'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.', 'detailedDescription': 'This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Confirmed metastatic prostate cancer\n* No more than one prior chemotherapy on which the disease progressed\n* ECOG performance status of less than or equal to 2\n* Adequate bone marrow, renal and hepatic functions as defined in the protocol\n* Neuropathy less than or equal to 2\n* Reliable venous access for frequent study drug infusions\n\nExclusion Criteria\n\n* Significant cardiovascular disease\n* Known active brain metastases\n* Subjects that have received treatment for other malignancies with in the past 5 years\n* Other clinically significant uncontrolled conditions'}, 'identificationModule': {'nctId': 'NCT00808418', 'briefTitle': 'A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synta Pharmaceuticals Corp.'}, 'officialTitle': 'A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)', 'orgStudyIdInfo': {'id': '4783-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort', 'interventionNames': ['Drug: Elesclomol Sodium', 'Drug: Docetaxel']}], 'interventions': [{'name': 'Elesclomol Sodium', 'type': 'DRUG', 'description': 'Chemotherapy agent', 'armGroupLabels': ['Cohort']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Chemotherapy agent', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Coast Hematology/Oncology Medical Group', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mayo Clinic'}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Mid Dakota Clinic', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Paul P. Carbone Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synta Pharmaceuticals Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}