Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
Study NCT ID:
NCT00079950
Status:
SUSPENDED
Last Update Posted:
2012-09-06
First Post:
2004-03-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C115093', 'term': 'pegamotecan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2004-03-18', 'studyFirstSubmitQcDate': '2004-03-19', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['soft', 'sarcoma', 'metastatic'], 'conditions': ['Sarcoma, Soft Tissue']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease.\n* Target tumors outside prior radiation field(s).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.\n* Adequate renal function\n* Adequate liver function\n* No history of hemorrhagic cystitis or evidence of microscopic hematuria\n* Capable of understanding the protocol requirements and risks and providing written informed consent.\n* Either 0 or 1 prior chemotherapy regimens\n\nExclusion Criteria:\n\n* Subject has a diagnosis of gastrointestinal stromal tumors.\n* Concurrent serious medical illness unrelated to tumor within the past 6 months.\n* Known chronic infectious disease, such as AIDS or hepatitis.\n* Positive screening pregnancy test or is breast-feeding.\n* A female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this study.\n* Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide field radiation within the previous 4 weeks.\n* History of another active malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for the last 2 years.\n* Known or clinically suspected brain metastases.\n* Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant therapy) for soft tissue sarcoma.\n* Received any investigational drug within the last 30 days.\n* Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy or radiation therapy.\n* Received a prior camptothecin analog (e.g., topotecan, irinotecan).'}, 'identificationModule': {'nctId': 'NCT00079950', 'briefTitle': 'Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enzon Pharmaceuticals, Inc.'}, 'orgStudyIdInfo': {'id': 'CAM-9009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pegamotecan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90067', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Century City Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Oncology Hematology Association', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Institute for Drug Development Cancer Therapy and Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enzon Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Senior Director, Regulatory Affairs', 'oldOrganization': 'Enzon Pharmaceuticals'}}}}