Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01071018
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2010-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'interventionBrowseModule': {'meshes': [{'id': 'C548887', 'term': 'MK 2206'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-04', 'studyFirstSubmitDate': '2010-02-17', 'studyFirstSubmitQcDate': '2010-02-17', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)', 'timeFrame': 'Day 1 - Day 28 (Cycle 1)'}], 'secondaryOutcomes': [{'measure': 'Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax', 'timeFrame': 'Day 1 - Day 28 (Cycle 1)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['locally advanced or metastatic solid tumors'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '26104654', 'type': 'BACKGROUND', 'citation': 'Doi T, Tamura K, Tanabe Y, Yonemori K, Yoshino T, Fuse N, Kodaira M, Bando H, Noguchi K, Shimamoto T, Ohtsu A. Phase 1 pharmacokinetic study of the oral pan-AKT inhibitor MK-2206 in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Aug;76(2):409-16. doi: 10.1007/s00280-015-2810-z. Epub 2015 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy\n* Has adequate organ function\n* Is ECOG Performance Scale 0-1\n* Has a negative urine pregnancy test if patient is female\n* Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis\n\nExclusion Criteria:\n\n* Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment\n* Is currently participating or has participated in a study with an investigational compound or device within 28 days\n* Has a primary central nervous system tumor\n* Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure\n* Is a known diabetic who is taking insulin or oral antidiabetic therapy\n* Is pregnant or breastfeeding or planning to become pregnant during the study\n* Is positive HIV antibody, HBs antigen or HCV antibody'}, 'identificationModule': {'nctId': 'NCT01071018', 'briefTitle': 'A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': '2206-007'}, 'secondaryIdInfos': [{'id': '2010_509'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QOD Schedule', 'description': 'QOD Schedule, MK2206 every other day', 'interventionNames': ['Drug: MK2206 every other day']}, {'type': 'EXPERIMENTAL', 'label': 'QW Schedule', 'description': 'QW Schedule, MK2206 once weekly', 'interventionNames': ['Drug: MK2206 once weekly']}], 'interventions': [{'name': 'MK2206 every other day', 'type': 'DRUG', 'otherNames': ['MK2206'], 'description': 'Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 45 mg and 60 mg, once daily every other day in repeating 4 week cycles.', 'armGroupLabels': ['QOD Schedule']}, {'name': 'MK2206 once weekly', 'type': 'DRUG', 'otherNames': ['MK2206'], 'description': 'Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 135 mg and 200 mg, once weekly in repeating 4 week cycles.', 'armGroupLabels': ['QW Schedule']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}