Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-27 @ 5:39 PM
Study NCT ID:
NCT00112060
Status:
WITHDRAWN
Last Update Posted:
2014-03-31
First Post:
2005-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C085590', 'term': 'N(alpha)-(4-amino-4-deoxypteroyl)-N(delta)-hemiphthaloyl-L-ornithine'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-27', 'studyFirstSubmitDate': '2005-05-27', 'studyFirstSubmitQcDate': '2005-05-27', 'lastUpdatePostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Talotrexin', 'PT-523', 'Non-Small Cell Lung Carcinoma (NSCLC)'], 'conditions': ['Non-Small-Cell Lung Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hanabiosciences.com', 'label': 'Hana Biosciences, Inc. is a South San Francisco, CA - based biopharmaceutical company that acquires, develops, and commercializes innovative products to advance cancer care.'}]}, 'descriptionModule': {'briefSummary': 'This phase I/II, multi-centered, non-randomized trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically or cytologically confirmed NSCLC which is stage III or stage IV, or recurrent disease, and failed therapy with a standard first line (Phase I/II) as well as second line chemotherapy regimen (Phase I), or be intolerant of standard chemotherapy. Receipt of one additional prior chemotherapy regimen for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant is allowable. A prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TK) antagonist is allowable (Phase II).\n* Asymptomatic or treated brain metastases (including steroids) if last therapy was received \\> 4 weeks from study entry and is deemed by the investigator to have a low likelihood of rapid deterioration.\n* ECOG performance status 0 - 2.\n* Adequate organ function and bone marrow reserve.\n* Use of appropriate contraceptive method.\n* Signed patient informed consent.\n\nExclusion Criteria:\n\n* Investigational agents within 30 days prior to Day 1 of study.\n* Known symptomatic or uncontrolled brain metastases.\n* Uncontrolled intercurrent illness.\n* Known human immunodeficiency virus (HIV), hepatitis A, B, C, D and E.\n* Patient has uncontrolled pleural effusions.\n* Patient has received nitrosoureas or mitomycin-C within 6 weeks or other chemotherapy or radiation therapy within 3 weeks before study entry.'}, 'identificationModule': {'nctId': 'NCT00112060', 'briefTitle': 'A Study to Assess the Safety and Preliminary Efficacy of PT-523 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectrum Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase I/II, Open-Label, Multicenter Study of Single Agent PT-523 in the Treatment of Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'HBS101'}, 'secondaryIdInfos': [{'id': 'HBS101.00'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'PT-523 for Injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami and Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University & University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '454087', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Chelyabinsk Regional Oncology Center Chemotherapy Department', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '664035', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Irkutsk Regional Oncology Center', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Blokhin Cancer Research Center Department of Chemotherapy and Combination Treatment of Neoplasia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Blokhin Cancer Research Center Department of Clinical Pharmacology and Chemotherapy', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129128', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Semashko Central Clinical Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg Pavlov State Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Petrov Research Institute of Oncology', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198255', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg Oncology Center Thoracic Department', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '150054', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Yaroslavl City Oncology Center', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spectrum Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}