Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-31 @ 7:17 AM
Study NCT ID:
NCT00656461
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2008-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of MKC-1 in Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-23', 'studyFirstSubmitDate': '2008-04-07', 'studyFirstSubmitQcDate': '2008-04-07', 'lastUpdatePostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.', 'timeFrame': 'Throughout study participation'}], 'secondaryOutcomes': [{'measure': 'Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement.', 'timeFrame': 'During study participation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced cancer'], 'conditions': ['Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective.\n* Age greater than or equal to 18 years.\n* ECOG performance status ≤1\n* ANC greater than or equal to 1,500/mm3;\n* Platelets greater than or equal to 100,000/mm3\n* creatinine ≤1.5 times institutional upper limit of normal (ULN)\n* T Bili within normal limits;\n* AST and ALT less than or equal to 2.5 times ULN; and\n* albumin greater than or equal to 3.0 g/dL\n* have measurable disease by RECIST, radiographically evaluable disease, or detectable disease\n* women of child-bearing potential and men must agree to use adequate contraception\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Have previously received MKC-1.\n* Have received radiation to greater than 25% of the bone marrow.\n* Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Are concurrently receiving any other investigational agents while on study.\n* Have known brain metastases\n* Have any condition that impairs the ability to swallow and retain MKC-1 capsules.\n* Uncontrolled intercurrent illness\n* Are pregnant or breastfeeding\n* HIV-positive patients\n* Patients with uncontrolled diabetes'}, 'identificationModule': {'nctId': 'NCT00656461', 'briefTitle': 'Phase 1 Study of MKC-1 in Patients With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'CASI Pharmaceuticals, Inc.'}, 'officialTitle': 'Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies', 'orgStudyIdInfo': {'id': 'MKC-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: MKC-1']}], 'interventions': [{'name': 'MKC-1', 'type': 'DRUG', 'description': '30 mg and 100 mg capsules, dosed BID daily on a continuous schedule', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Glenn Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U. of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CASI Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Miikana Therapeutics, an EntreMed, Inc. company'}}}}