Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-04 @ 5:00 PM
Study NCT ID:
NCT00057395
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C054367', 'term': 'bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'statusVerifiedDate': '2004-04', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2003-04-01', 'studyFirstSubmitQcDate': '2003-04-01', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Esophageal Neoplasms', 'Esophagus Neoplasm', 'Esophagus Cancer', 'Esophageal Cancer', 'Esophageal Tumors', 'Esophagus Tumors', 'Neoplasms, Esophageal', 'Hepatocellular Carcinoma', 'Carcinoma, Hepatocellular', 'Hepatoma', 'Colorectal Neoplasms', 'Colorectal Cancer', 'Colorectal Carcinoma', 'Colorectal Tumor', 'Neoplasms, Colorectal', 'Ovarian Neoplasms', 'Ovary Neoplasms', 'Ovary Cancer', 'Ovary Carcinoma', 'Ovarian Cancer', 'Ovarian Carcinoma', 'Neoplasms, Ovarian', 'Pancreatic Neoplasms', 'Pancreatic Cancer', 'Pancreas Neoplasms', 'Pancreas Cancer', 'Neoplasms, Pancreatic', 'Neoplasms, Pancreas', 'and other solid tumors'], 'conditions': ['Esophageal Neoplasms', 'Hepatocellular Carcinoma', 'Colorectal Neoplasms', 'Ovarian Neoplasms', 'Pancreatic Neoplasms', 'Neoplasms']}, 'descriptionModule': {'briefSummary': 'To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.', 'detailedDescription': 'Primary Objective:\n\n* Determine response rate (RR; complete and partial response \\[CR, PR\\]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.\n\nSecondary Objective:\n\n* Determine the safety and tolerability of Aroplatin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced solid malignancies;\n* Amenable to therapy with DACH platinum agents;\n* Measurable disease (RECIST criteria);\n* ECOG performance score of 0-2;\n* Adequate hematopoietic, liver and renal function;\n* Adequate cardiac function (maximum of class II, NYHA);\n* Women of childbearing potential must have a negative urine or serum pregnancy test;\n* Signed written informed consent;\n* Subjects must be willing to be followed during the course of treatment/observation and follow-up.\n\nExclusion Criteria:\n\n* No other active malignancies;\n* No prior therapy with oxaliplatin;\n* No known brain metastases;\n* Active, uncontrolled infection or other serious medical illnesses;\n* Not using or have used any investigational therapy during four weeks before start of protocol treatment.'}, 'identificationModule': {'nctId': 'NCT00057395', 'briefTitle': 'A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aronex Pharmaceuticals'}, 'officialTitle': 'A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies', 'orgStudyIdInfo': {'id': 'C-726-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aroplatin (Liposomal NDDP, L-NDDP)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'John Wayne Cancer Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aronex Pharmaceuticals', 'class': 'INDUSTRY'}}}}