Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092028', 'term': 'beta-D-glucosylisophosphoramide mustard'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-28', 'studyFirstSubmitDate': '2004-12-10', 'studyFirstSubmitQcDate': '2004-12-09', 'lastUpdatePostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival'}], 'secondaryOutcomes': [{'measure': 'Objective tumor response rate'}, {'measure': 'Duration of objective tumor response rate'}, {'measure': 'Progression-free survival'}, {'measure': '6 month and 12 month survival'}, {'measure': 'Serum CA 19-9'}, {'measure': 'Pain Intensity'}, {'measure': 'Performance Status'}]}, 'conditionsModule': {'keywords': ['Pancreas', 'Cancer', 'Pancreatic Adenocarcinoma', 'Metastatic', 'Glufosfamide'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.thresholdpharm.com', 'label': 'Threshold Pharmaceuticals Website'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of the study is to evaluate the effectiveness and safety of glufosfamide in subjects with pancreatic cancer who have been previously treated with gemcitabine as measured by overall survival compared with best supportive care.', 'detailedDescription': 'TH-CR-302 is a randomized Phase 3 study that will evaluate the efficacy and safety of glufosfamide plus best supportive care (BSC) compared to BSC alone for second line treatment of metastatic pancreatic cancer. BSC includes all medical or surgical interventions that a pancreatic cancer patient should receive to palliate the cancer but excludes treatment with systemic therapies intended to kill the cancer cells.\n\nStudy Hypothesis: Glufosfamide will provide benefits in survival to patients with metastatic pancreatic cancer over best supportive care.\n\nComparison: Glufosfamide versus best supportive care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years of age\n* Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)\n* Metastatic pancreatic cancer\n* Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses) for advanced/metastatic pancreatic cancer\n* Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)\n* Recovered from reversible toxicities of prior therapy\n* Karnofsky performance status ≥70\n* All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose\n* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee\n\nExclusion Criteria:\n\n* More than one prior systemic therapy regimen for metastatic/locally advanced pancreatic cancer (radiosensitizing doses of 5FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)\n* Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to study start\n* Symptomatic brain metastases (baseline CT scan is not required in asymptomatic subjects)\n* Active clinically significant infection requiring antibiotics\n* Known HIV positive or active hepatitis B or C\n* Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure\n* No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year\n* Major surgery within 3 weeks of the start of study treatment, without complete recovery\n* Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis) (Hemoglobin \\<9 g/dL (may receive transfusion or erythropoietin to maintain))"}, 'identificationModule': {'nctId': 'NCT00099294', 'briefTitle': 'Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Threshold Pharmaceuticals'}, 'officialTitle': 'A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Best Supportive Care in Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine', 'orgStudyIdInfo': {'id': 'TH-CR-302'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Glufosfamide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Augusta Oncology Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kenmar Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mile High Oncology', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06790', 'city': 'Torrington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Northwestern Connecticut Oncology - Hematology Associates', 'geoPoint': {'lat': 41.80065, 'lon': -73.12122}}, {'zip': '33435', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Institute of Hematology and Oncology', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hematology/Oncology of the North Shore', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '46815', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology/Hem', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Hattiesburg Clinic Oncology', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Columbia Comprehensive Cancer Care Clinic', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '65401', 'city': 'Rolla', 'state': 'Missouri', 'country': 'United States', 'facility': 'Bond Clinic', 'geoPoint': {'lat': 37.95143, 'lon': -91.77127}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Deaconess Billings Clinic', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '07652', 'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Office of Clinical Trials', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico Oncology Hematology Consultants', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hanover Medical Specialists', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Vita Hematology Oncology PC', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '38017', 'city': 'Collierville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Family Cancer Center , PLLC', 'geoPoint': {'lat': 35.04204, 'lon': -89.66453}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Oncology Research and Treatment', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'JPS Center for Cancer Care', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Northern Utah Associates', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '24211', 'city': 'Abingdon', 'state': 'Virginia', 'country': 'United States', 'facility': 'Cancer Outreach Association', 'geoPoint': {'lat': 36.70983, 'lon': -81.97735}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic Research Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '1650', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Interzonal General de Agudos', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1706', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Posadas', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B8000FTS', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Policlinica Privada Instituto de Medicina Nuclear', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1120AAF', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Udaondo', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1406FWY', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Alvarez', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1437JCP', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Churruca - 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