Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT00327327
Status:
COMPLETED
Last Update Posted:
2010-09-15
First Post:
2006-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C014919', 'term': '4-imino-1,3-diazabicyclo(3.1.0)hexan-2-one'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-14', 'studyFirstSubmitDate': '2006-05-17', 'studyFirstSubmitQcDate': '2006-05-17', 'lastUpdatePostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine maximally tolerated dose (MTD)', 'timeFrame': 'until MTD reached'}, {'measure': 'determine dose limiting toxicities.', 'timeFrame': 'until MTD reached'}], 'secondaryOutcomes': [{'measure': 'Changes in plasma thiol levels', 'timeFrame': 'until MTD reached'}, {'measure': 'pharmacokinetics', 'timeFrame': 'until MTD reached'}, {'measure': 'objective tumor responses.', 'timeFrame': 'until MTD reached'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '19855966', 'type': 'RESULT', 'citation': 'Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007/s00280-009-1162-y. Epub 2009 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inoperable cancer of the pancreas.\n* Blood cell counts and blood chemistries in or near normal range.\n* Able to perform the activities of daily living.\n* A projected life expectancy of at least 2 months.\n* If female, neither pregnant nor nursing.\n* Willing to use contraceptives to prevent pregnancy.\n* No other serious illnesses.\n* No other active malignancy.\n* No serious infections.\n* No current other drug therapy for the cancer or steroid therapy.\n* Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.\n\nExclusion Criteria:\n\n* Prior chemotherapy for metastatic disease.\n* Brain metastases'}, 'identificationModule': {'nctId': 'NCT00327327', 'briefTitle': 'Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AmpliMed Corporation'}, 'officialTitle': 'A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma', 'orgStudyIdInfo': {'id': 'AMP-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'imexon', 'type': 'DRUG', 'description': '30-60 minutes IV, days 1,8,15 every 28 days'}, {'name': 'gemcitabine', 'type': 'DRUG', 'description': '30 minutes IV, days 1,8,15 every 28 days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'US Oncology Orlando, Cancer Centers of FL', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'US Oncology Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Univ of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'US Oncology Albany, New York Oncology', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '45409', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'US Oncology Kettering', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Ctr.', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'US Oncology, Virginia Oncology Assoc', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'US Oncology Northwest, Northwest Cancer Specialists', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': 'Mark Zalupski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Steven Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AmpliMed Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Evan Hersh, VP Medical Affairs', 'oldOrganization': 'AmpliMed Corporation'}}}}