Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT00310518
Status:
COMPLETED
Last Update Posted:
2009-04-29
First Post:
2006-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C014638', 'term': 'beta-lapachone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-28', 'studyFirstSubmitDate': '2006-03-31', 'studyFirstSubmitQcDate': '2006-03-31', 'lastUpdatePostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the overall response rate (ORR) of persistent, recurrent or metastatic leiomyosarcoma in patients treated with ARQ 501.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide signed and dated informed consent prior to study-specific screening procedures.\n* Histologically or cytologically confirmed leiomyosarcoma that is persistent, recurrent or metastatic.\n* Measurable disease as defined by RECIST.\n* Karnofsky performance status \\>= 70%\n* Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501.\n* Hemoglobin (Hgb) \\>= 10 g/dL.\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9/L (\\>= 1,500/mm3).\n* Platelet count \\>= 100 x 10\\^9/L (\\>= 100,000/mm3).\n* Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 3.0 x ULN with metastatic liver disease.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN less than or equal to 5.0 ULN with metastatic liver disease.\n* Creatinine less than or equal to 1.5 x ULN.\n\nExclusion Criteria:\n\n* Received three or more prior anticancer chemotherapy regimens.\n* Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.\n* Have received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or investigational agents within four weeks of first infusion.\n* Have symptomatic or untreated central nervous system (CNS) involvement.\n* Are pregnant or breastfeeding.\n* Previous exposure to ARQ 501.'}, 'identificationModule': {'nctId': 'NCT00310518', 'briefTitle': 'Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)'}, 'officialTitle': 'A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma', 'orgStudyIdInfo': {'id': 'ARQ 501-221'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ARQ 501', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Premiere Oncology of Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Premiere Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Oncology Hematology Associates', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)', 'class': 'INDUSTRY'}}}}