Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-29 @ 1:08 PM
Study NCT ID:
NCT01110603
Status:
TERMINATED
Last Update Posted:
2016-05-05
First Post:
2010-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545685', 'term': 'niraparib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-04', 'studyFirstSubmitDate': '2010-04-22', 'studyFirstSubmitQcDate': '2010-04-23', 'lastUpdatePostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with dose limiting toxicities (DLTs)', 'timeFrame': 'Each cycle (21 or 28 Days)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with clinical and laboratory adverse events (AEs)', 'timeFrame': 'Baseline to 30 days post last dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Advanced Solid Tumors'], 'conditions': ['Cancer: Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.', 'detailedDescription': 'The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.\n* Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n\nExclusion Criteria:\n\n* Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.\n* Participant has had more than two prior lines of chemotherapy.\n* Participant has known central nervous system metastases or a primary central nervous system tumor.\n* Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.\n* Participant is known to be human immunodeficiency virus (HIV) positive.\n* Participant has a history of Hepatitis B or C.\n* Participant has a symptomatic pleural effusion.\n* Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.'}, 'identificationModule': {'nctId': 'NCT01110603', 'briefTitle': 'A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tesaro, Inc.'}, 'officialTitle': 'A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '2010_528'}, 'secondaryIdInfos': [{'id': 'MK-4827-008'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-4827 + carboplatin', 'interventionNames': ['Drug: MK-4827', 'Drug: carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'MK-4827 + carboplatin/paclitaxel', 'interventionNames': ['Drug: MK-4827', 'Drug: carboplatin', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MK-4827 + carboplatin/liposomal doxorubicin', 'interventionNames': ['Drug: MK-4827', 'Drug: carboplatin', 'Drug: liposomal doxorubicin']}], 'interventions': [{'name': 'MK-4827', 'type': 'DRUG', 'description': 'Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.', 'armGroupLabels': ['MK-4827 + carboplatin', 'MK-4827 + carboplatin/liposomal doxorubicin', 'MK-4827 + carboplatin/paclitaxel']}, {'name': 'carboplatin', 'type': 'DRUG', 'description': 'Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle', 'armGroupLabels': ['MK-4827 + carboplatin', 'MK-4827 + carboplatin/liposomal doxorubicin', 'MK-4827 + carboplatin/paclitaxel']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': 'Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle', 'armGroupLabels': ['MK-4827 + carboplatin/paclitaxel']}, {'name': 'liposomal doxorubicin', 'type': 'DRUG', 'description': 'Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle', 'armGroupLabels': ['MK-4827 + carboplatin/liposomal doxorubicin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tesaro, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}