Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-23 @ 7:05 AM
Study NCT ID:
NCT00093132
Status:
TERMINATED
Last Update Posted:
2012-08-17
First Post:
2004-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D002282', 'term': 'Adenocarcinoma, Bronchiolo-Alveolar'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081294', 'term': 'satraplatin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Sponsor decided to discontinue study drug development.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'dispFirstSubmitDate': '2012-08-09', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-09', 'studyFirstSubmitDate': '2004-10-01', 'dispFirstSubmitQcDate': '2012-08-09', 'studyFirstSubmitQcDate': '2004-10-01', 'dispFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of MTD and recommended dose for phase II trials', 'timeFrame': '30 days'}]}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer (stage II or III)', 'NSCLC', 'Squamous Cell Lung Cancer', 'adenocarcinoma of the lung', 'adenosquamous cell lung cancer', 'bronchoalveolar cell lung cancer', 'carcinoma, non-small cell lung'], 'conditions': ['Carcinoma, Non-small Cell Lung', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'PURPOSE: This trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.\n\nWHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.\n\nRATIONALE: Intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced or medically inoperable NSCLC (stage II or III)\n* ECOG performance status score 0-2\n* Adequate bone marrow, liver, and pulmonary functions\n* Life expectancy \\> three months.\n\nExclusion Criteria:\n\n* Prior malignancy\n* Serious concurrent uncontrolled medical disorder.\n* Uncontrolled or significant cardiovascular disease\n* History of mastectomy\n* Pregnant or breast-feeding patients are not eligible\n* Prior radiotherapy to the primary tumor site or cytotoxic chemotherapy'}, 'identificationModule': {'nctId': 'NCT00093132', 'briefTitle': 'Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Agennix'}, 'officialTitle': 'A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'SAT1-04-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Satraplatin', 'description': 'Satraplatin', 'interventionNames': ['Drug: Satraplatin']}], 'interventions': [{'name': 'Satraplatin', 'type': 'DRUG', 'description': 'Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.', 'armGroupLabels': ['Satraplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agennix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}