Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-20 @ 3:57 PM
Study NCT ID:
NCT00300950
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2006-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2006-03-08', 'studyFirstSubmitQcDate': '2006-03-08', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence free time and survival', 'timeFrame': '5 years'}]}, 'conditionsModule': {'keywords': ['Pancreas Cancer', 'resected pancreas cancer', 'non-metastatic pancreas cancer'], 'conditions': ['Pancreas Cancer']}, 'referencesModule': {'references': [{'pmid': '33786412', 'type': 'DERIVED', 'citation': 'Muscarella P, Bekaii-Saab T, McIntyre K, Rosemurgy A, Ross SB, Richards DA, Fisher WE, Flynn PJ, Mattson A, Coeshott C, Roder H, Roder J, Harrell FE, Cohn A, Rodell TC, Apelian D. A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer. J Pancreat Cancer. 2021 Mar 23;7(1):8-19. doi: 10.1089/pancan.2020.0021. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '(A few general items required)\n\nInclusion Criteria:\n\n* Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation\n* \\>18 years of age\n* Negative skin test for hypersensitivity to Saccharomyces cerevisiae\n\nExclusion Criteria:\n\n* Metastatic pancreas cancer patients post-resection\n* Patients with no product-related ras mutation.'}, 'identificationModule': {'nctId': 'NCT00300950', 'briefTitle': 'Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlobeImmune'}, 'officialTitle': 'A Phase 2 Double-Blind, Placebo Controlled, Multi-center Adjuvant Trial of the Efficacy, Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With a Gemcitabine Regimen Versus a Gemcitabine Regimen With Placebo, in Patients With Post-resection R0/R1 Pancreatic Cancer With Tumor Sequence Confirmation of Ras Mutations.', 'orgStudyIdInfo': {'id': 'GI-4000-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Gencitabine', 'interventionNames': ['Biological: GI-4000']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Gemcitabine with GI-4000', 'interventionNames': ['Drug: Gemcitabine']}], 'interventions': [{'name': 'GI-4000', 'type': 'BIOLOGICAL', 'description': 'Heat-killed yeast cell transfected with target ras mutation.', 'armGroupLabels': ['1']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Tower Cancer Research Foundation', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center / Lombardi Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical School', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Oncology Hematology, PA', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'State University of NY at Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, PA', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75237', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The Texas Cancer Center Dallas Southwest', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'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}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Multi-Disciplinary Cancer Clinic', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '641004', 'city': 'Peelamedu, Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'PSG Hospitals'}, {'zip': '600116', 'city': 'Ponur, Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Sri Ramchandra Medical College & Research Institute', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '500034', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Indo American Cancer Hospital and Research Centre', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '575001', 'city': 'Mangalore', 'country': 'India', 'facility': 'KMC Hospital', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'city': 'Nagpur', 'country': 'India', 'facility': 'Govt Medical Colleg & Hospital', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '682304', 'city': 'Nettoor, Cochin', 'country': 'India', 'facility': 'Lake Shore Hospital & Research Centre', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'zip': '110002', 'city': 'New Delhi', 'country': 'India', 'facility': 'G B Pan Hospital & Maulana Azad Medical College', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '500082', 'city': 'Panjagutta, Hyderaba', 'country': 'India', 'facility': "Nizam's Institute of Medical Sciences", 'geoPoint': {'lat': 17.42251, 'lon': 78.45204}}, {'zip': '600096', 'city': 'Perungudi, Chennai', 'country': 'India', 'facility': 'Lifeline Multispecialty Hospital'}, {'zip': '695011', 'city': 'Trivandrum', 'country': 'India', 'facility': 'Regional Cancer Centre', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlobeImmune', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}