Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT02673060
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2016-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of MBC-11 in Patients With CIBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2016-01-22', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'up to 20 weeks', 'description': 'evaluation of adverse events, physical examination, laboratory parameters'}, {'measure': 'Dose Limiting Toxicity [DLT]', 'timeFrame': 'up to 20 weeks', 'description': 'dose limiting toxicity is graded according to NCI CN CFT version 4'}, {'measure': 'Maximum tolerated dose', 'timeFrame': 'up to 20 weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration [Cmax] of MBC-11', 'timeFrame': '5 weeks', 'description': 'Cmax will be evaluated during Cycle 1'}, {'measure': 'Pharmacodynamic parameters', 'timeFrame': 'up to 20 weeks', 'description': 'Levels of bone turnover markers is measured'}, {'measure': 'Fluorodeoxyglucose positron emission tomography-computed tomography [FDG PET-CT] response after cycle 2 and cycle 4 therapy', 'timeFrame': 'up to 20 weeks', 'description': 'Response rate according to Positrone Emission Tomography Response Criteria in Solid Tumors \\[PERCIST\\] criteria using FDG PET/CT'}, {'measure': 'Maximum Plasma Concentration [Cmax] of etidronate', 'timeFrame': '5 weeks', 'description': 'pharmacokinetics \\[PK\\] assessment of MBC-11 metabolite'}, {'measure': 'Maximum Plasma Concentration [Cmax] of ara-U', 'timeFrame': '5 weeks', 'description': 'PK assessment of MBC-11 metabolite'}, {'measure': 'Peak time [Tmax] for MBC-11', 'timeFrame': '5 weeks', 'description': 'PK parameters assessment of study drug'}, {'measure': 'Peak time [Tmax] for etidronate', 'timeFrame': '5 weeks', 'description': 'PK assessment of MBC-11metabolite'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bone Metastasis']}, 'referencesModule': {'references': [{'pmid': '30413669', 'type': 'DERIVED', 'citation': 'Zinnen SP, Karpeisky A, Von Hoff DD, Plekhova L, Alexandrov A. First-in-Human Phase I Study of MBC-11, a Novel Bone-Targeted Cytarabine-Etidronate Conjugate in Patients with Cancer-Induced Bone Disease. Oncologist. 2019 Mar;24(3):303-e102. doi: 10.1634/theoncologist.2018-0707. Epub 2018 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates MBC-11 (a conjugate of a bone-targeting vehicle (etidronate) and a cytostatic agent \\[ara-C\\] in patients with malignant tumors with CIBD. This is a first use in human.', 'detailedDescription': 'A standard "3+3" dose escalation design to determine Maximum Tolerated Dose with consecutive different dose level cohort recruitment.\n\nThe following dose levels to be investigated: 0.5 mg/kg, 1.0 mg/kg, 2.5 mg/kg, 5.0 mg/kg, 10 mg/kgm 20 mg/kg. The study for each patient consists of 14-days screening period, single dose administration of MBC-11 followed by 7-day safety monitoring and then 2 cycles of multiple use of MBC-11 (28 days each cycle, study drug is administered at Days1-5). In case of partial metabolic reaction/stable metabolic reaction therapy maybe prolonged up to 4 cycles (at investigator and sponsor consideration)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed malignant tumor (breast cancer, prostate cancer etc)\n* Bone metastases, documented by radiographs, bone scan\n* No available standard chemotherapy or no indication for chemotherapy at the time of screening\n* Eastern Cooperative Oncology Group \\[ECOG\\] status 0-2\n* Adequate bone marrow function (hemoglobin ≥ 9 g/dL with or without transfusion requirement, absolute neutrophil count ≥ 1500/mm3, and platelets ≥ 75,000/mm3)\n* Adequate liver function (bilirubin ≤ 2 x Upper Limit of Normal \\[ULN\\], Alanine aminotransferase \\[ALT\\] ≤ 2.5 x ULN).\n* Adequate renal function (creatinine ≤ 1.5 x ULN) and creatinine clearance ≥ 50 mL/min \\[measured or calculated by nomogram\\]).\n\nExclusion Criteria:\n\n* Systemic chemotherapy and/or investigational therapy within the previous 4 weeks\n* Fracture ≤ 6 month prior the inclusion in the study\n* Brain metastasis\n* Serum calcium levels \\< 8.5 mg/dL (\\< 2.2 mmol/L)'}, 'identificationModule': {'nctId': 'NCT02673060', 'briefTitle': 'A Trial of MBC-11 in Patients With CIBD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Osteros Biomedica Ltd'}, 'officialTitle': 'A Phase 1 Multicenter, Open-label, Dose-escalation Trial of MBC-11, an Etidronate-ara-C Conjugate in Patients With Malignant Tumors With Cancer-induced Bone Disease (CIBD)', 'orgStudyIdInfo': {'id': 'OB-MBC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose escalation of MBC-11', 'description': 'MBC-11 was administered in 5 consecutively recruited cohort in dose 0.5 mg/kg, 1 mg/kg, 2.5 mg/kg, 5 mg/kg,10 mg/kg accordingly. The dose escalation is aimed at determining the maximum tolerated dose (MTD)', 'interventionNames': ['Drug: MBC-11']}], 'interventions': [{'name': 'MBC-11', 'type': 'DRUG', 'description': '0.5 mg/kg-10 mg/kg , IV (in the vein) on day 1-5 of each 28 day cycle. Number of cycles: 2, in case of partial metabolic reaction or stable metabolic reaction - up to 4.', 'armGroupLabels': ['dose escalation of MBC-11']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osteros Biomedica Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}