Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-04-23 @ 11:51 AM
Study NCT ID:
NCT02949895
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2016-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BMS-986012 in Subjects With Small Cell Lung Caner
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of participants with serious adverse events (SAEs )', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Discontinuations due to AEs', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of Deaths due to AEs', 'timeFrame': 'Up to 2 years'}, {'measure': 'Number of participants with laboratory toxicity grade shift from baseline', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Maximum observed serum concentration (Cmax)', 'timeFrame': 'Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose'}, {'measure': 'Time of maximum observed serum concentration(Tmax)', 'timeFrame': 'Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T))', 'timeFrame': 'Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose'}, {'measure': 'Observed serum concentration at the end of a dosing interval(Ctau)', 'timeFrame': 'Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose'}, {'measure': 'Area under the concentration-time curve in 1 dosing interval(AUC(TAU))', 'timeFrame': 'Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose'}, {'measure': 'Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA)', 'timeFrame': 'Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose'}, {'measure': 'Best overall response (BOR)', 'timeFrame': 'Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\n* Histological or cytological confirmed small cell lung cancer (SCLC)\n* Eastern Cooperative Oncology Group Performance Status 0-1\n* at least one measurable lesion that is not amenable to resection.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastases\n* Grade ≥ 2 peripheral neuropathy\n* Uncontrolled or significant cardiac disease\n* Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT02949895', 'briefTitle': 'Study of BMS-986012 in Subjects With Small Cell Lung Caner', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CA001-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Dose 1', 'description': 'BMS-986012 Dose Escalation Dose 1', 'interventionNames': ['Drug: BMS-986012']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Dose 2', 'description': 'BMS-986012 Dose Escalation Dose 2', 'interventionNames': ['Drug: BMS-986012']}, {'type': 'EXPERIMENTAL', 'label': 'Chemotherapy Combination', 'description': 'BMS-986012 + Cisplatin + Etoposide', 'interventionNames': ['Drug: BMS-986012', 'Drug: Cisplatin', 'Drug: Etoposide']}], 'interventions': [{'name': 'BMS-986012', 'type': 'DRUG', 'armGroupLabels': ['Chemotherapy Combination', 'Dose Escalation Dose 1', 'Dose Escalation Dose 2']}, {'name': 'Cisplatin', 'type': 'DRUG', 'armGroupLabels': ['Chemotherapy Combination']}, {'name': 'Etoposide', 'type': 'DRUG', 'armGroupLabels': ['Chemotherapy Combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5698686', 'city': 'Takatsuki-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '1040045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}