Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-02 @ 1:40 AM
Study NCT ID:
NCT00530192
Status:
COMPLETED
Last Update Posted:
2009-07-10
First Post:
2007-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Profiling Protocol (SCRI-CA-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-03'}, 'lastUpdateSubmitDate': '2009-07-09', 'studyFirstSubmitDate': '2007-09-14', 'studyFirstSubmitQcDate': '2007-09-14', 'lastUpdatePostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.', 'timeFrame': 'Every 8 weeks disease assessments are performed'}], 'secondaryOutcomes': [{'measure': "To determine the frequency with which molecular profiling of a patient's tumor by IHC/FISH and/or microarray analysis yields a target against which there is a commercially available, approved therapeutic regimen.", 'timeFrame': 'Time of Profiling- Baseline'}, {'measure': 'To determine the response rate (according to RECIST or disease-specific response criteria) and the percent of patients with non-progression at 4 months in patients with solid tumors whose therapy is selected by molecular profiling.', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Refractory Cancer', 'Molecular Profile'], 'conditions': ['Refractory Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter pilot study in patients with advanced solid tumors.\n\nThe primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.\n\nTo be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease.\n* Be defined as refractory to the last line of therapy\n* Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study\n\nExclusion Criteria:\n\n* Patients with symptomatic CNS metastasis\n* Any previous history of another malignancy within 5 years of study entry\n* Uncontrolled intercurrent illness\n* Known HIV, HBV, HCV infection\n* Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00530192', 'briefTitle': 'Molecular Profiling Protocol (SCRI-CA-001)', 'organization': {'class': 'OTHER', 'fullName': 'Scottsdale Healthcare'}, 'officialTitle': "A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers", 'orgStudyIdInfo': {'id': 'SCRI-CA-001'}, 'secondaryIdInfos': [{'id': 'SCRI-CA-001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Treatment based on Molecular Profiling', 'type': 'OTHER', 'description': 'Treatment with commercially available treatments (per package insert instructions)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Oncology Specialties', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'TGen Clinical Research Services', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Tower Oncology', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Central Indiana Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Center of the Carolinas', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Oncology Hematology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cancer Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Daniel D Von Hoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TGen Clinical Research Services at Scottsdale Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scottsdale Healthcare', 'class': 'OTHER'}, 'collaborators': [{'name': 'Translational Genomics Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Scottsdale Healthcare'}}}}