Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT00716794
Status:
COMPLETED
Last Update Posted:
2011-03-09
First Post:
2008-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Study of HE3235 in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540077', 'term': '17-ethynylandrostane-3,17-diol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-08', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-14', 'lastUpdatePostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerance of HE3235 when administered orally to prostate cancer patients in 28 day cycles.', 'timeFrame': 'Treatment period'}, {'measure': 'To evaluate the pharmacokinetic profiles of HE3235 and major metabolites at different dose levels after 28 days of dosing.', 'timeFrame': 'Treatment period'}, {'measure': 'To assess potential activity of HE3235 in prostate cancer patients.', 'timeFrame': 'Treatment period and post-study follow-up period'}], 'secondaryOutcomes': [{'measure': 'Explore circulating tumor cell (CTC) enumeration in response to treatment as a marker evaluating whether an investigational therapy is effective for tumor treatment', 'timeFrame': 'Treatment period'}, {'measure': 'Evaluate the role of molecular profiling of CTC in predicting sensitivity to treatment and treatment response.', 'timeFrame': 'Treament period and post-study follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'HE3235', 'Apoptone'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase I/II, open-label, dose escalation study of HE3235 administered orally to patients with advanced prostate cancer who have failed hormone therapy and at least one taxane based chemotherapy regimen.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Patient is male and at least 18 years of age, at the time of screening;\n* Patient has metastatic disease (any T, any N, M1);\n* Patient has failed at least 1 taxane regimen; or Patient has symptomatic or asymptomatic CRPC and is chemotherapy-naìˆve\n* Patient has histologically or cytologically confirmed adenocarcinoma of the prostate;\n* Patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following:\n\n * PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart.\n * Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria;\n * Progression of metastatic bone disease on bone scan with \\> 2 new lesions\n* Patient has ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;\n\nMain Exclusion Criteria:\n\n* Patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation Treated epidural disease is allowed\n* Patient has active infection;\n* Patient having a history of clinically significant cardiovascular disease (such as CHF), clinically significant hepatic, respiratory or renal abnormalities;\n* Patient who has any clinically significant abnormalities in laboratory results at screening\n* Patient who has a history of clinically significant neurological or psychiatric condition;\n\nAdditional criteria are applicable to expansion cohorts.'}, 'identificationModule': {'nctId': 'NCT00716794', 'briefTitle': 'A Phase I/II Study of HE3235 in Patients With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Harbor Therapeutics'}, 'officialTitle': 'A Phase I/II, Open-Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Activity of HE3235 When Administered Orally to Patients With Prostate Cancer', 'orgStudyIdInfo': {'id': 'HE3235-0201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HE3235', 'type': 'DRUG', 'otherNames': ['Apoptone'], 'description': 'HE3235 will be administered orally in 28 day cycles.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Dwight Stickney, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harbor Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harbor Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Nanette Onizuka-Handa/Sr. Vice President, Regulatory Affairs and Quality', 'oldOrganization': 'Harbor BioSciences, Inc.'}}}}