Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00075933
Status:
COMPLETED
Last Update Posted:
2009-04-28
First Post:
2004-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ARQ 501 in Subjects With Cancer
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-27', 'studyFirstSubmitDate': '2004-01-12', 'studyFirstSubmitQcDate': '2004-01-12', 'lastUpdatePostDateStruct': {'date': '2009-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': "ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints known to be defective in cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT).\n\nARQ 501 has the potential for improved activity and reduced toxicity over other molecular approaches and traditional cancer chemotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Histologically or cytologically confirmed solid tumor that is metastatic, unresectable or recurrent and for which standard curative or palliative measures do not exist or are no longer effective.\n* ECOG performance status greater than or equal to 1\n* Life expectancy greater than three months\n* Acceptable pretreatment clinical laboratory results\n\nExclusion Criteria\n\n* Subjects who have had chemotherapy or radiotherapy within 4 weeks\n* Subjects receiving any other investigational agents\n* Subjects with known untreated brain metastases\n* Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD")\n* Subjects with uncontrolled intercurrent illnesses\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT00075933', 'briefTitle': 'ARQ 501 in Subjects With Cancer', '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 I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'ARQ 501-101'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ARQ 501', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber/Partners CancerCare Inc', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Medical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Geoffrey I Shapiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}, {'name': 'C. Casey Cunningham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mary Crowley Medical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)', 'class': 'INDUSTRY'}}}}