Nctid:
NCT06221072
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009362", "term"=>"Neoplasm Metastasis"}, {"id"=>"D001859", "term"=>"Bone Neoplasms"}, {"id"=>"D001855", "term"=>"Bone Marrow Diseases"}], "ancestors"=>[{"id"=>"D009385", "term"=>"Neoplastic Processes"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D001847", "term"=>"Bone Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}], "browseLeaves"=>[{"id"=>"M12307", "name"=>"Neoplasm Metastasis", "asFound"=>"Metastases", "relevance"=>"HIGH"}, {"id"=>"M5138", "name"=>"Bone Neoplasms", "asFound"=>"Bone Metastases", "relevance"=>"HIGH"}, {"id"=>"M5134", "name"=>"Bone Marrow Diseases", "asFound"=>"Bone Metastases", "relevance"=>"HIGH"}, {"id"=>"M12330", "name"=>"Neoplastic Processes", "relevance"=>"LOW"}, {"id"=>"M5126", "name"=>"Bone Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077211", "term"=>"Zoledronic Acid"}], "ancestors"=>[{"id"=>"D050071", "term"=>"Bone Density Conservation Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M1699", "name"=>"Zoledronic Acid", "asFound"=>"Everolimus", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Double-blind"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"multicenter, randomized, double-blind clinical Trail"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1360}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-04-05", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2028-05-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-14", "studyFirstSubmitDate"=>"2024-01-14", "studyFirstSubmitQcDate"=>"2024-01-14", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-05-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Time to the First on-study Skeletal-Related Event (SRE)", "timeFrame"=>"Up to approximately 48 months"}], "secondaryOutcomes"=>[{"measure"=>"Time to First and Subsequent SRE (21 days from the last SRE is subsequent SRE)", "timeFrame"=>"Up to approximately 48 months"}, {"measure"=>"Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (NTx/Cr)", "timeFrame"=>"Up to approximately 28 months"}, {"measure"=>"Quality of life score (concise pain assessment Scale and EQ-5D-5L scale);", "timeFrame"=>"Up to approximately 48 months"}, {"measure"=>"Incidence and severity of adverse events (AEs)", "timeFrame"=>"Up to approximately 48 months"}, {"measure"=>"JMT103 The incidence of injection anti-drug antibodies (ADA) and neutralizing antibodies (Nab)", "timeFrame"=>"Up to approximately 48 months"}, {"measure"=>"Serum concentration of JMT103", "timeFrame"=>"Up to approximately 48 months"}, {"measure"=>"Overall survival (OS)", "timeFrame"=>"Up to approximately 6 years"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors"]}, "descriptionModule"=>{"briefSummary"=>"This is a phase Ⅲ, multicenter, randomized, double-blind, study to evaluate the efficacy and safety of JMT103 in patients with bone metastases from malignant solid tumors. The purpose of this study is to determine if JMT103 is non-inferior to zoledronic acid."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age: older than 18 years;\n2. Breast cancer, prostate cancer, lung cancer and other solid tumors diagnosed by histological or cytological examination (prostate patients should also meet: castration-resistant prostate cancer with serum testosterone \\<50 ng/dL or 1.7 nmol/L and serum PSA progression after surgery or drug castration treatment);\n3. Patients with imaging studies showing at least one tumor bone metastasis;\n4. With a good organ function;\n5. Expected survival of at least 6 months.\n\nExclusion Criteria:\n\n1. Previous or ongoing osteomyelitis or osteonecrosis of the jaw; dental or oral surgery; acute dental or jaw disease requiring oral surgery; invasive dental procedures planned during the study; patients with pulpitis during the screening period;\n2. Radiotherapy or surgery for the bone metastases is planned during the study;\n3. Patients with brain metastasis or meningeal metastasis (patients with neurological symptoms should undergo MRI/CT examination to exclude patients with brain metastasis);\n4. Patients with bone metabolic diseases \\[e.g., Paget's disease, Cushing's syndrome, hyperprolactinemia, hyperthyroidism/hypothyroid (except for hypothyroidism with normal TSH, FT3, and FT4 after stable thyroid hormone replacement therapy, and subclinical hypothyroidism that does not need to be treated), hyper/hypoparathyroidism, etc.\\];\n5. Uncontrolled concurrent diseases, including but not limited to: uncontrolled diabetes mellitus (≥grade 3, NCI-CTCAE 5.0), symptomatic congestive heart failure, hypertension (BP\\> 150/90 mmHg after standard therapy), unstable angina, arrhythmia requiring medical or instrumental treatment, history of myocardial infarction within 6 months, echocardiography with left ventricular ejection fraction \\<50%;\n6. Treatment with anti-RANKL antibody, bisphosphonates (except for bone scan purposes) within 6 months prior to the first dose;\n7. Patients considered by the investigator as unsuitable for this study (such as poor compliance, etc.)."}, "identificationModule"=>{"nctId"=>"NCT06221072", "briefTitle"=>"A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Shanghai JMT-Bio Inc."}, "officialTitle"=>"A Phase III, Multicenter, Randomized, Double-blind Clinical Trail to Assess JMT103 Compared to Azoledronic Acid for the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors", "orgStudyIdInfo"=>{"id"=>"JMT103-012"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group 1-JMT103", "description"=>"Participants will receive JMT103 and zoledronic acid placebo.", "interventionNames"=>["Drug: JMT103"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group 2-zoledronic acid", "description"=>"Participants will receive zoledronic acid and JMT103 placebo.", "interventionNames"=>["Drug: zoledronic acid"]}], "interventions"=>[{"name"=>"JMT103", "type"=>"DRUG", "description"=>"120 mg by subcutaneous injection every 4 weeks", "armGroupLabels"=>["Group 1-JMT103"]}, {"name"=>"zoledronic acid", "type"=>"DRUG", "description"=>"4 mg by intravenous drip (100mL:4mg) every 4 weeks", "armGroupLabels"=>["Group 2-zoledronic acid"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Clinical Trials Information Group officer", "role"=>"CONTACT", "email"=>"ctr-contact@cspc.cn", "phone"=>"86-0311-69085587"}, {"name"=>"Zefei Jiang, M.D", "role"=>"CONTACT", "email"=>"jzf_cscobc@csco.org.cn", "phone"=>"13901372170"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai JMT-Bio Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
